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Redesigning the ‘choice architecture’ of hospital prescription charts: a mixed methods study incorporating in situ simulation testing

D King, A Jabbar, E Charani

BMJ Open 2014

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Objectives To incorporate behavioural insights into the user-centred design of an inpatient prescription chart (Imperial Drug Chart Evaluation and Adoption Study, IDEAS chart) and to determine whether changes in the content and design of prescription charts could influence prescribing behaviour and reduce prescribing errors. Design A mixed-methods approach was taken in the development phase of the project; in situ simulation was used to evaluate the effectiveness of the newly developed IDEAS prescription chart. Setting A London teaching hospital. Interventions/methods A multimodal approach comprising (1) an exploratory phase consisting of chart reviews, focus groups and user insight gathering (2) the iterative design of the IDEAS prescription chart and finally (3) testing of final chart with prescribers using in situ simulation. Results Substantial variation was seen between existing inpatient prescription charts used across 15 different UK hospitals. Review of 40 completed prescription charts from one hospital demonstrated a number of frequent prescribing errors including illegibility, and difficulty in identifying prescribers. Insights from focus groups and direct observations were translated into the design of IDEAS chart. In situ simulation testing revealed significant improvements in prescribing on the IDEAS chart compared with the prescription chart currently in use in the study hospital. Medication orders on the IDEAS chart were significantly more likely to include correct dose entries (164/164 vs 166/174; p=0.0046) as well as prescriber's printed name (163/164 vs 0/174; p<0.0001) and contact number (137/164 vs 55/174; p<0.0001). Antiinfective indication (28/28 vs 17/29; p<0.0001) and duration (26/28 vs 15/29; p<0.0001) were more likely to be completed using the IDEAS chart. Conclusions In a simulated context, the IDEAS prescription chart significantly reduced a number of common prescribing errors including dosing errors and illegibility. Positive behavioural change was seen without prior education or support, suggesting that some common prescription writing errors are potentially rectifiable simply through changes in the content and design of prescription charts.

 


Stating Appointment Costs in SMS Reminders Reduces Missed Hospital Appointments: Findings from Two Randomised Controlled Trials

M Hallsworth, D Berry, M Sanders, Sallis A, D King, I Vlaev

PLoS ONE 10(9): e0137306. pmid:26366885

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Missed hospital appointments are a major cause of inefficiency worldwide. Healthcare providers are increasingly using Short Message Service reminders to reduce ‘Did Not Attend’ (DNA) rates. Systematic reviews show that sending such reminders is effective, but there is no evidence on whether their impact is affected by their content. Accordingly, we undertook two randomised controlled trials that tested the impact of rephrasing appointment reminders on DNA rates in the United Kingdom. Participants were outpatients with a valid mobile telephone number and an outpatient appointment between November 2013 and January 2014 (Trial One, 10,111 participants) or March and May 2014 (Trial Two, 9,848 participants). Appointments were randomly allocated to one of four reminder messages, which were issued five days in advance. Message assignment was then compared against appointment outcomes (appointment attendance, DNA, cancellation by patient). In Trial One, a message including the cost of a missed appointment to the health system produced a DNA rate of 8.4%, compared to 11.1% for the existing message (OR 0.74, 95% CI 0.61–0.89, P<0.01). Trial Two replicated this effect (DNA rate 8.2%), but also found that expressing the same concept in general terms was significantly less effective (DNA rate 9.9%, OR 1.22, 95% CI 1.00–1.48, P<0.05). Moving from the existing reminder to the more effective costs message would result in 5,800 fewer missed appointments per year in the National Health Service Trust in question, at no additional cost. The study’s main limitations are that it took place in a single location in England, and that it required accurate phone records, which were only obtained for 20% of eligible patients. We conclude that missed appointments can be reduced, for no additional cost, by introducing persuasive messages to appointment reminders. Future studies could examine the impact of varying reminder messages in other health systems.

 


Source Dispensers and Home Delivery of Chlorine in Kenya

S Asman, C Casarotto

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Researchers sought to examine the impact of factors including price, persuasion, promotion and the chlorination products themselves with a two-phase study. Prior to the study baseline surveys were administered to a random selection of households.In the first phase, households were given seven WaterGuard bottles, an individual water treatment product, each sufficient for one month’s supply of clean water. They were also provided with improved drinking water storage pots with a tap to prevent contamination and detailed instructions on use. One third of this group received twelve coupons for a 50 percent discount on WaterGuard bottles, each valid for one month during the next year, and calendars with reminders. Another third received additional verbal persuasion messages beyond the basic WaterGuard instructions, and another third received no additional coupons or messages. To estimate social networking effects, the free WaterGuard bottles were distributed in different percentages in each community, allowing researchers to see if higher community levels of use increased individual adoption. A follow-up survey was administered between 2 and 7 months after the free WaterGuard was distributed.In the second phase researchers compared six different treatments designed to increase WaterGuard adoption. For the first three treatments, scripted promotional messages were delivered at either the(1) household level, (2) community level, or (3) both. The second two treatments included repeated promotion of chlorination through a home visit by a community elected promoter. Despite volunteering to work for free, the promoter was paid either a (4) flat rate, or was (5) paid based on how many households had chlorinated water at follow-up visits. The last treatment (6) combined the incentivized promoter model with an unlimited supply of free WaterGuard delivered through a point-of-collection chlorine dispenser at the local water source. Follow-up surveys were conducted 3 weeks and 3-6 months after the start of the study.

 


Financial incentives for home-based health monitoring: a randomized controlled trial.

KG. Volpp, DA Asch, George Loewenstein, JD Park, J Zhu, Y Tao, MF Hu, SL Bellamy, B Stearman, EB Riley, TB Sewell, AP Sen

J Gen Intern Med. 2014 May;29(5):770-7.

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BACKGROUND: Home wireless device monitoring could play an important role in improving the health of patients with poorly controlled chronic diseases, but daily engagement rates among these patients may be low. OBJECTIVE: To test the effectiveness of two different magnitudes of financial incentives for improving adherence to remote-monitoring regimens among patients with poorly controlled diabetes. DESIGN: Randomized, controlled trial. (Clinicaltrials.gov Identifier: NCT01282957). PARTICIPANTS: Seventy-five patients with a hemoglobin A1c greater than or equal to 7.5% recruited from a Primary Care Medical Home practice at the University of Pennsylvania Health System. INTERVENTIONS: Twelve weeks of daily home-monitoring of blood glucose, blood pressure, and weight (control group; n = 28); a lottery incentive with expected daily value of $2.80 (n = 26) for daily monitoring; and a lottery incentive with expected daily value of $1.40 (n = 21) for daily monitoring. MAIN MEASURES: Daily use of three home-monitoring devices during the three-month intervention (primary outcome) and during the three-month follow-up period and change in A1c over the intervention period (secondary outcomes). KEY RESULTS: Incentive arm participants used devices on a higher proportion of days relative to control (81% low incentive vs. 58%, P = 0.007; 77% high incentive vs. 58%, P = 0.02) during the three-month intervention period. There was no difference in adherence between the two incentive arms (P = 0.58). When incentives were removed, adherence in the high incentive arm declined while remaining relatively high in the low incentive arm. In month 6, the low incentive arm had an adherence rate of 62% compared to 35% in the high incentive arm (P = 0.015) and 27% in the control group (P = 0.002). CONCLUSIONS: A daily lottery incentive worth $1.40 per day improved monitoring rates relative to control and had significantly better efficacy once incentives were removed than a higher incentive.

 


The Impact of Text Message Reminders on Adherence to Antimalarial Treatment in Northern Ghana: A Randomized Trial

JR Raifman

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Background Low rates of adherence to artemisinin-based combination therapy (ACT) regimens increase the risk of treatment failure and may lead to drug resistance, threatening the sustainability of current anti-malarial efforts. We assessed the impact of text message reminders on adherence to ACT regimens. Methods Health workers at hospitals, clinics, pharmacies, and other stationary ACT distributors in Tamale, Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment. The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals. The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation. We estimated the impact of the messages on treatment completion using logistic regression. Results 1140 individuals enrolled in both the study and the text reminder system. Among individuals in the control group, 61.5% took the full course of treatment. The simple text message reminders increased the odds of adherence (adjusted OR 1.45, 95% CI [1.03 to 2.04], p-value 0.028). Receiving an additional message did not result in a significant change in adherence (adjusted OR 0.77, 95% CI [0.50 to 1.20], p-value 0.252). Conclusion The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment. Further research is needed to develop the most effective text message content and frequency.

 


Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders

C Pop-Eleches

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Objective There is limited evidence on whether growing mobile phone availability in sub-Saharan Africa can be used to promote high adherence to antiretroviral therapy (ART). This study tested the efficacy of short message service (SMS) reminders on adherence to ART among patients attending a rural clinic in Kenya. Design A randomized controlled trial of four SMS reminder interventions with 48 weeks of follow-up. Methods Four hundred and thirty-one adult patients who had initiated ART within 3 months were enrolled and randomly assigned to a control group or one of the four intervention groups. Participants in the intervention groups received SMS reminders that were either short or long and sent at a daily or weekly frequency. Adherence was measured using the medication event monitoring system. The primary outcome was whether adherence exceeded 90% during each 12-week period of analysis and the 48-week study period. The secondary outcome was whether there were treatment interruptions lasting at least 48 h. Results In intention-to-treat analysis, 53% of participants receiving weekly SMS reminders achieved adherence of at least 90% during the 48 weeks of the study, compared with 40% of participants in the control group (P=0.03). Participants in groups receiving weekly reminders were also significantly less likely to experience treatment interruptions exceeding 48 h during the 48-week follow-up period than participants in the control group (81 vs. 90%, P = 0.03). Conclusion These results suggest that SMS reminders may be an important tool to achieve optimal treatment response in resource-limited settings.

 



Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices

D Meeker

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Importance Interventions based on behavioral science might reduce inappropriate antibiotic prescribing. Objective To assess effects of behavioral interventions and rates of inappropriate (not guideline-concordant) antibiotic prescribing during ambulatory visits for acute respiratory tract infections. Design, Setting, and Participants Cluster randomized clinical trial conducted among 47 primary care practices in Boston and Los Angeles. Participants were 248 enrolled clinicians randomized to receive 0, 1, 2, or 3 interventions for 18 months. All clinicians received education on antibiotic prescribing guidelines on enrollment. Interventions began between November 1, 2011, and October 1, 2012. Follow-up for the latest-starting sites ended on April 1, 2014. Adult patients with comorbidities and concomitant infections were excluded. Interventions Three behavioral interventions, implemented alone or in combination: suggested alternatives presented electronic order sets suggesting nonantibiotic treatments; accountable justification prompted clinicians to enter free-text justifications for prescribing antibiotics into patients’ electronic health records; peer comparison sent emails to clinicians that compared their antibiotic prescribing rates with those of “top performers” (those with the lowest inappropriate prescribing rates). Main Outcomes and Measures Antibiotic prescribing rates for visits with antibiotic-inappropriate diagnoses (nonspecific upper respiratory tract infections, acute bronchitis, and influenza) from 18 months preintervention to 18 months afterward, adjusting each intervention’s effects for co-occurring interventions and preintervention trends, with random effects for practices and clinicians. Results There were 14 753 visits (mean patient age, 47 years; 69% women) for antibiotic-inappropriate acute respiratory tract infections during the baseline period and 16 959 visits (mean patient age, 48 years; 67% women) during the intervention period. Mean antibiotic prescribing rates decreased from 24.1% at intervention start to 13.1% at intervention month 18 (absolute difference, −11.0%) for control practices; from 22.1% to 6.1% (absolute difference, −16.0%) for suggested alternatives (difference in differences, −5.0% [95% CI, −7.8% to 0.1%]; P = .66 for differences in trajectories); from 23.2% to 5.2% (absolute difference, −18.1%) for accountable justification (difference in differences, −7.0% [95% CI, −9.1% to −2.9%]; P < .001); and from 19.9% to 3.7% (absolute difference, −16.3%) for peer comparison (difference in differences, −5.2% [95% CI, −6.9% to −1.6%]; P < .001). There were no statistically significant interactions (neither synergy nor interference) between interventions. Conclusions and Relevance Among primary care practices, the use of accountable justification and peer comparison as behavioral interventions resulted in lower rates of inappropriate antibiotic prescribing for acute respiratory tract infections.

 


Nudging Guideline-Concordant Antibiotic Prescribing

D Meeker

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Importance “Nudges” that influence decision making through subtle cognitive mechanisms have been shown to be highly effective in a wide range of applications, but there have been few experiments to improve clinical practice. Objective To investigate the use of a behavioral “nudge” based on the principle of public commitment in encouraging the judicious use of antibiotics for acute respiratory infections (ARIs). Design, Setting, and Participants Randomized clinical trial in 5 outpatient primary care clinics. A total of 954 adults had ARI visits during the study timeframe: 449 patients were treated by clinicians randomized to the posted commitment letter (335 in the baseline period, 114 in the intervention period); 505 patients were treated by clinicians randomized to standard practice control (384 baseline, 121 intervention). Interventions The intervention consisted of displaying poster-sized commitment letters in examination rooms for 12 weeks. These letters, featuring clinician photographs and signatures, stated their commitment to avoid inappropriate antibiotic prescribing for ARIs. Main Outcomes and Measures Antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses in baseline and intervention periods, adjusted for patient age, sex, and insurance status. Results Baseline rates were 43.5% and 42.8% for control and poster, respectively. During the intervention period, inappropriate prescribing rates increased to 52.7% for controls but decreased to 33.7% in the posted commitment letter condition. Controlling for baseline prescribing rates, we found that the posted commitment letter resulted in a 19.7 absolute percentage reduction in inappropriate antibiotic prescribing rate relative to control (P = .02). There was no evidence of diagnostic coding shift, and rates of appropriate antibiotic prescriptions did not diminish over time. Conclusions and Relevance Displaying poster-sized commitment letters in examination rooms decreased inappropriate antibiotic prescribing for ARIs. The effect of this simple, low-cost intervention is comparable in magnitude to costlier, more intensive quality-improvement efforts.

 


Peer Mentoring and Financial Incentives to Improve Glucose Control in African American Veterans: A Randomized, Controlled Trial

JA Long

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Background Compared to whites, African Americans have a greater incidence of diabetes, decreased control, and higher rates of micro-vascular complications. A peer mentorship model could be a scalable approach to improving control in this population and reducing disparities in diabetic outcomes. Objective To determine whether peer mentors or financial incentives are superior to usual care in helping African American Veterans improve their glycosylated hemoglobin (HbA1c) levels. Design A six month randomized controlled trial. (ClinicalTrials.gov registration number: NCT01125956) Setting The Philadelphia VA Medical Center. Patients African American veterans, age 50-70 years old, with persistently poor diabetes control. Measurements Change in HbA1c at 6 months Intervention 118 participants were randomized to one of the three arms. Usual care participants were notified of their starting HbA1c and recommended goals for HbA1c. Those in the peer mentor arm were assigned a peer mentor who formerly had poor glycemic control but now had good control (HbA1c < 7.5%) who was asked to talk with the participant at least once a week. Peer mentors were matched on race, sex, and age. Those in the financial incentive arm could earn $100 by dropping their HbA1c by one point and $200 by dropping it by two points or to a HbA1c of 6.5%. Results Mentors and mentees talked the most in the first month (mean calls 4: range 0-30) and dropped to a mean of 2 calls (range 0-10) by the sixth month. HbA1c dropped from 9.9% to 9.8% in the control arm, 9.8% to 8.7% in the peer mentor arm and from 9.5% to 9.1% in the financial incentive arm. Mean change in HbA1c from baseline to 6 months relative to control was −1.07 (95% CI −1.84 to −0.31) in the peer mentor arm and −0.45 (95% CI −1.23 to 0.32) in the financial incentive arm. Limitations The study included only veterans and lasted only 6 months. Conclusions Peer mentorship improved glucose control in a cohort of African American Veterans with diabetes.

 



Web-Based Access to Positive Airway Pressure Usage with or without an Initial Financial Incentive Improves Treatment Use in Patients with Obstructive Sleep Apnea.

ST Kuna

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We tested whether providing adults with obstructive sleep apnea (OSA) with daily Web-based access to their positive airway pressure (PAP) usage over 3 mo with or without a financial incentive in the first week improves adherence and functional outcomes.Academic- and community-based sleep centers.One hundred thirty-eight adults with newly diagnosed OSA starting PAP treatment.Participants were randomized to: usual care, usual care with access to PAP usage, or usual care with access to PAP usage and a financial incentive. PAP data were transmitted daily by wireless modem from the participants' PAP unit to a website where hours of usage were displayed. Participants in the financial incentive group could earn up to $30/day in the first week for objective PAP use ≥ 4 h/day.Mean hours of daily PAP use in the two groups with access to PAP usage data did not differ from each other but was significantly greater than that in the usual care group in the first week and over 3 mo (P < 0.0001). Average daily use (mean ± standard deviation) during the first week of PAP intervention was 4.7 ± 3.3 h in the usual care group, and 5.9 ± 2.5 h and 6.3 ± 2.5 h in the Web access groups with and without financial incentive respectively. Adherence over the 3-mo intervention decreased at a relatively constant rate in all three groups. Functional Outcomes of Sleep Questionnaire change scores at 3 mo improved within each group (P < 0.0001) but change scores of the two groups with Web access to PAP data were not different than those in the control group (P > 0.124).Positive airway pressure adherence is significantly improved by giving patients Web access to information about their use of the treatment. Inclusion of a financial incentive in the first week had no additive effect in improving adherence.

 


Individual- versus group-based financial incentives for weight loss: a randomized, controlled trial

JT Kullgren

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BACKGROUND: Data on the effectiveness of employer-sponsored financial incentives for employee weight loss are limited. OBJECTIVE: To test the effectiveness of 2 financial incentive designs for promoting weight loss among obese employees. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov: NCT01208350) SETTING: Children's Hospital of Philadelphia. PARTICIPANTS: 105 employees with a body mass index between 30 and 40 kg/m2. INTERVENTION: 24 weeks of monthly weigh-ins (control group; n = 35); individual incentive, designed as $100 per person per month for meeting or exceeding weight-loss goals (n = 35); and group incentive, designed as $500 per month split among participants within groups of 5 who met or exceeded weight-loss goals (n = 35). MEASUREMENTS: Weight loss after 24 weeks (primary outcome) and 36 weeks and changes in behavioral mediators of weight loss (secondary outcomes). RESULTS: Group-incentive participants lost more weight than control participants (mean between-group difference, 4.4 kg [95% CI, 2.0 to 6.7 kg]; P < 0.001) and individual-incentive participants (mean between-group difference, 3.2 kg [CI, 0.9 to 5.5 kg]; P = 0.008). Twelve weeks after incentives ended and after adjustment for 3-group comparisons, group-incentive participants maintained greater weight loss than control group participants (mean between-group difference, 2.9 kg [CI, 0.5 to 5.3 kg]; P = 0.016) but not greater than individual-incentive participants (mean between-group difference, 2.7 kg [CI, 0.4 to 5.0 kg]; P = 0.024). LIMITATION: Single employer and short follow-up. CONCLUSION: A group-based financial incentive was more effective than an individual incentive and monthly weigh-ins at promoting weight loss among obese employees at 24 weeks.

 


Randomized trial of lottery-based incentives to improve warfarin adherence

SE Kimmel

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Background Poor adherence to medications is a major cause of morbidity and inadequate drug effectiveness. Efforts to improve adherence have typically been either ineffective or too complex to implement in clinical practice. Lottery-based incentive interventions could be a scalable approach to improving adherence.MethodsThis was a randomized, controlled clinical trial of a daily lottery-based incentive in patients on warfarin stratified by baseline international normalized ratio (INR). The trial randomized 100 patients to either a lottery-based incentive or no lottery intervention. Main outcome was out-of-range INRs.ResultsOver 6 months, the overall percentage of out-of-range INRs did not differ between the 2 arms (mean 23.0% in lottery arm and 25.9% in control arm, adjusted odds ratio[OR]0.93,95%CI0.62-1.41). However, among the a priori subgroup with a baseline INR below therapeutic range, there was a significant reduction in out-of-range INR in the lottery arm versus the control arm (adjusted OR 0.39, 95% CI 0.25-0.62), whereas there was no such effect among those with therapeutic INRs at baseline(adjusted OR 1.26, 95% CI, 0.76-2.09, P value for interaction = .0016). Among those with low INR at baseline, there was a nonsignificant 49% reduction in the odds of nonadherence with the intervention (OR 0.51, 95% CI 0.23-1.14).ConclusionsAlthough a lottery-based intervention was not associated with a significant improvement in anticoagulation control among all study participants, it improved control among an a priori group of patients at higher risk for poor adherence.(Am Heart J 2012;164:268-74.)

 


The Impact of Alternative Incentive Schemes on Completion of Health Risk Assessments

E Haisley, Kevin Volpp, T Pellathy, George Loewenstein

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Purpose. The biggest challenge for corporate wellness initiatives is low rates of employee participation. We test whether a behavioral economic approach to incentive design (i.e., a lottery) is more effective than a direct economic payment of equivalent monetary value (i.e., a grocery gift certificate) in encouraging employees to complete health risk assessments (HRAs). Design. Employees were assigned to one of three arms. Assignment to a treatment arm versus the nontreatment arm was determined by management. Assignment to an arm among those eligible for treatment was randomized by office. Setting. A large health care management and information technology consulting company. Patients. A total of 1299 employees across 14 offices participated. Intervention. All employees were eligible to receive $25 for completing the HRA. Those in the lottery condition were assigned to teams of four to eight people and, conditional on HRA completion, were entered into a lottery with a prize of $100 (expected value, $25) and a bonus value of an additional $25 if 80% of team members participated. Those in the grocery gift certificate condition who completed an HRA received a $25 grocery gift certificate. Those in the comparison condition received no additional incentive. Measures. HRA completion rates. Analysis. Logistic regression analysis. Results. HRA completion rates were significantly higher among participations in the lottery incentive condition (64%) than in both the grocery gift certificate condition (44%) and the comparison condition (40%). Effects were larger for lower-income employees, as indicated by a significant interaction between income and the lottery incentive. Conclusion. Lottery incentives that incorporate regret aversion and social pressure can provide higher impact for the same amount of money as simple economic incentives.

 





Risking it all for love? Resetting beliefs about HIV risk among low-income South African teens

S Datta

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Research suggests that the much higher HIV prevalence among young women in sub-Saharan Africa than among males of their age cohort is linked to the high prevalence of age-disparate sexual partnerships, and that incorrect beliefs about the relationship between age and HIV-risk are partly responsible. We report the results of an experiment that tests whether a simple, computer-based “HIV risk game” leads to better understanding of the relationship between HIV-risk and age among low-income South African adolescents than a version of the traditional “brochure approach” to dispensing information does. Our results are striking. The randomly assigned treatment group, which receives repeated doses of information about the link between age and HIV-risk as feedback to their own responses to simple questions about relative HIV-risk, is significantly more likely to correctly identify which of a pair of hypothetical men or women of different ages is more likely to have HIV than the control group. Subjects in the treatment group answer, on average, 1.65 times as many questions about HIV risk and age correctly as those in the control group. We also find that subjects’ (particularly female subjects’) beliefs about HIV risk among women are less accurate than their beliefs about HIV risk among men. Finally, a follow-up survey with no significant difference in attrition rates between those in the treatment and control groups, shows substantially higher information retention among treatment subjects than among control subjects.

 



Integrating a Parenting Intervention With Routine Primary Health Care: A Cluster Randomized Trial

SM Chang

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OBJECTIVE: More than 200 million children globally do not attain their developmental potential. We hypothesized that a parent training program could be integrated into primary health center visits and benefit child development. METHODS: We conducted a cluster randomized trial in the Caribbean (Jamaica, Antigua, and St Lucia). Fifteen centers were randomly assigned to the control (n = 250 mother-child pairs) and 14 to the intervention (n = 251 mother-child pairs) groups. Participants were recruited at the 6- to 8-week child health visit. The intervention used group delivery at 5 routine visits from age 3 to 18 months and comprised short films of child development messages, which were shown in the waiting area; discussion and demonstration led by community health workers; and mothers’ practice of activities. Nurses distributed message cards and a few play materials. Primary outcomes were child cognition, language, and hand-eye coordination and secondary outcomes were caregiver knowledge, practices, maternal depression, and child growth, measured after the 18-month visit. RESULTS: Eight-five percent of enrolled children were tested (control = 210, intervention = 216). Loss did not differ by group. Multilevel analyses showed significant benefits for cognitive development (3.09 points; 95% confidence interval: 1.31 to 4.87 points; effect size: 0.3 SDs). There were no other child benefits. There was a significant benefit to parenting knowledge (treatment effect: 1.59; 95% confidence interval: 1.01 to 2.17; effect size: 0.4). CONCLUSIONS: An innovative parenting intervention, requiring no additional clinic staff or mothers’ time, was integrated into health services, with benefits to child cognitive development and parent knowledge. This is a promising strategy that merits further evaluation at scale.

 





Improving immunisation coverage in rural India: clustered randomised controlled evaluation of immunisation campaigns with and without incentives

AV Banerjee, Duflo, Glennerster, Kothari

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Objective To assess the efficacy of modest non-financial incentives on immunisation rates in children aged 1-3 and to compare it with the effect of only improving the reliability of the supply of services. Design Clustered randomised controlled study. Setting Rural Rajasthan, India. Participants 1640 children aged 1-3 at end point. Interventions 134 villages were randomised to one of three groups: a once monthly reliable immunisation camp (intervention A; 379 children from 30 villages); a once monthly reliable immunisation camp with small incentives (raw lentils and metal plates for completed immunisation; intervention B; 382 children from 30 villages), or control (no intervention, 860 children in 74 villages). Surveys were undertaken in randomly selected households at baseline and about 18 months after the interventions started (end point). Main outcome measures Proportion of children aged 1-3 at the end point who were partially or fully immunised. Results Among children aged 1-3 in the end point survey, rates of full immunisation were 39% (148/382, 95% confidence interval 30% to 47%) for intervention B villages (reliable immunisation with incentives), 18% (68/379, 11% to 23%) for intervention A villages (reliable immunisation without incentives), and 6% (50/860, 3% to 9%) for control villages. The relative risk of complete immunisation for intervention B versus control was 6.7 (4.5 to 8.8) and for intervention B versus intervention A was 2.2 (1.5 to 2.8). Children in areas neighbouring intervention B villages were also more likely to be fully immunised than those from areas neighbouring intervention A villages (1.9, 1.1 to 2.8). The average cost per immunisation was $28 (1102 rupees, about £16 or €19) in intervention A and $56 (2202 rupees) in intervention B. Conclusions Improving reliability of services improves immunisation rates, but the effect remains modest. Small incentives have large positive impacts on the uptake of immunisation services in resource poor areas and are more cost effective than purely improving supply.

 


Effect of Financial Incentives to Physicians, Patients, or Both on Lipid Levels: A Randomized Clinical Trial

DA Asch

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Importance Financial incentives to physicians or patients are increasingly used, but their effectiveness is not well established. Objective To determine whether physician financial incentives, patient incentives, or shared physician and patient incentives are more effective than control in reducing levels of low-density lipoprotein cholesterol (LDL-C) among patients with high cardiovascular risk. Design, Setting, and Participants Four-group, multicenter, cluster randomized clinical trial with a 12-month intervention conducted from 2011 to 2014 in 3 primary care practices in the northeastern United States. Three hundred forty eligible primary care physicians (PCPs) were enrolled from a pool of 421. Of 25 627 potentially eligible patients of those PCPs, 1503 enrolled. Patients aged 18 to 80 years were eligible if they had a 10-year Framingham Risk Score (FRS) of 20% or greater, had coronary artery disease equivalents with LDL-C levels of 120 mg/dL or greater, or had an FRS of 10% to 20% with LDL-C levels of 140 mg/dL or greater. Investigators were blinded to study group, but participants were not. Interventions Primary care physicians were randomly assigned to control, physician incentives, patient incentives, or shared physician-patient incentives. Physicians in the physician incentives group were eligible to receive up to $1024 per enrolled patient meeting LDL-C goals. Patients in the patient incentives group were eligible for the same amount, distributed through daily lotteries tied to medication adherence. Physicians and patients in the shared incentives group shared these incentives. Physicians and patients in the control group received no incentives tied to outcomes, but all patient participants received up to $355 each for trial participation. Main Outcomes and Measures Change in LDL-C level at 12 months. Results Patients in the shared physician-patient incentives group achieved a mean reduction in LDL-C of 33.6 mg/dL (95% CI, 30.1-37.1; baseline, 160.1 mg/dL; 12 months, 126.4 mg/dL); those in physician incentives achieved a mean reduction of 27.9 mg/dL (95% CI, 24.9-31.0; baseline, 159.9 mg/dL; 12 months, 132.0 mg/dL); those in patient incentives achieved a mean reduction of 25.1 mg/dL (95% CI, 21.6-28.5; baseline, 160.6 mg/dL; 12 months, 135.5 mg/dL); and those in the control group achieved a mean reduction of 25.1 mg/dL (95% CI, 21.7-28.5; baseline, 161.5 mg/dL; 12 months, 136.4 mg/dL; P < .001 for comparison of all 4 groups). Only patients in the shared physician-patient incentives group achieved reductions in LDL-C levels statistically different from those in the control group (8.5 mg/dL; 95% CI, 3.8-13.3; P = .002). Conclusions and Relevance In primary care practices, shared financial incentives for physicians and patients, but not incentives to physicians or patients alone, resulted in a statistically significant difference in reduction of LDL-C levels at 12 months. This reduction was modest, however, and further information is needed to understand whether this approach represents good value.

 










A brief intervention changing oral self-care, self-efficacy, and self-monitoring.

Ralf Schwarzer, Agata Antoniuk, Maryam Gholami

British journal of health psychology [20:56-67] (2015)

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The roles of self-efficacy and self-monitoring as proximal predictors of dental flossing frequency are studied in the context of an oral health intervention. A study among 287 university students, aged 19 to 26 years, compared an intervention group that received a brief self-regulatory treatment, with a passive and an active control group. Dental flossing, self-efficacy, and self-monitoring were assessed at baseline and 3 weeks later. The intervention led to an increase in dental flossing regardless of experimental condition. However, treatment-specific gains were documented for self-efficacy and self-monitoring. Moreover, changes in the latter two served as mediators in a path model, linking the intervention with subsequent dental flossing and yielding significant indirect effects. Self-efficacy and self-monitoring play a mediating role in facilitating dental flossing. Interventions that aim at an improvement in oral self-care should consider using these constructs. Statement of contribution What is already known on this subject? The adoption and maintenance of oral self-care can be facilitated by a number of social-cognitive variables. Interventions that include planning, action control, or self-efficacy components have been shown to improve dental flossing. In one recent study on flossing in adolescent girls, planning intervention effects were mediated by self-efficacy. What does this study add? Self-monitoring is associated with better oral self-care. A 10-min intervention improves self-efficacy and self-monitoring. Self-efficacy and self-monitoring operate as mediators between treatment and flossing.

 



The use of a mobile app to motivate evidence-based oral hygiene behaviour.

Underwood, Birdsall B, Kay J

British dental journal [219:166-7] (2015)

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Mobile apps are software programmes that run on smartphones and other mobile devices. Mobile health apps can help people manage their own health and wellness, promote healthy living and gain access to useful information when and where they need it. The Brush DJ oral health app was developed to use the opportunity mobile apps offer to motivate an evidence-based oral hygiene routine. A literature review has found no research investigating the use of a mobile app to motivate evidence-based oral hygiene behaviour. The objective of this preliminary investigation was to assess user perception of an oral health app to give a basis for future research and development of app technology in relation to oral health. A cross-sectional qualitative user perception questionnaire. One hundred and eighty-nine people responded to the questionnaire. Seventy percent (n = 113) of respondents reported that their teeth felt cleaner since using the app. Eighty-eight percent (n = 133) reported the app motivated them to brush their teeth for longer and 92.3% (n = 144) would recommend the app to their friends and family. Four broad themes relating to how the app helped toothbrushing were reported. These themes were motivation, education, compliance and perceived benefits. A mobile app is a promising tool to motivate an evidence-based oral hygiene routine.

 


An oral care self-management support protocol (OrCaSS) to reduce oral mucositis in hospitalized patients with acute myeloid leukemia and allogeneic hematopoietic stem cell transplantation: a randomized controlled pilot study.

Lynn Leppla, Sabina De Geest, Katharina Fierz, Barbara Deschler-Baier, Antje Koller

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer [24:773-82] (2016)

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Oral mucositis (OM) is a common and debilitating side effect of chemoradiotherapy in patients awaiting allogeneic hematopoietic stem cell transplantation (aHSCT). The aim of this pilot RCT was to compare an oral care self-management support protocol (OrCaSS) to usual pre-aHSCT care. Feasibility was tested, effect sizes calculated for OM (primary outcome), and patient adherence was measured (secondary outcome). Eighteen AML patients awaiting aHSCT and hospitalized between August 2012 and April 2013 were randomized 1:1 to usual care (UCG) and intervention (IG) groups. The OrCaSS protocol consisted of two sessions of educational and behavioral interventions, the first delivered 1 week pre-admission (T1), the second on admission day (T2). Via field notes, practicability and acceptability were evaluated to explore the feasibility of intervention and study procedures. OM data were collected at T1, T2, and daily for 28 days using the WHO scale. The effect size r was calculated (r less than -0.1 ≙ small and greater than or equal to -0.3 ≙ medium). Patients' adherence to the protocol was assessed at T1, T2, and 8-10 days post-HSCT (T3). Research and intervention procedures were feasible. OM incidence was 100 %. The IG's median highest OM grade was 2.0 (IQR = 2); the UCGs was 3.0 (IQR = 2; r = -0.1). Median OM durations were 12 days in the IG and 14 days in the UCG (r = -0.1). OM onset was 2 days later in the IG than in the UCG (r = -0.1). Over the course of the study, patient adherence decreased in both groups. OrCaSS is a promising intervention to delay and reduce OM. These results can serve to plan a larger RCT.

 




Train the trainer? A randomized controlled trial of a multi-tiered oral health education programme in community-based residential services for adults with intellectual disability.

Giolla Mac, Caoimhin Phadraig, Suzanne Guerin, June Nunn

Community dentistry and oral epidemiology [41:182-92] (2013)

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To assess the impact of a multi-tiered oral health education programme on care staff caring for people with intellectual disability (ID). Postal questionnaires were sent to all care staff of a community-based residential care service for adults, randomly assigned to control and intervention groups. A specifically developed training programme was delivered to residential staff nominees, who then trained all staff within the intervention group. The control group received no training. Post-test questionnaires were sent to both groups. Paired-samples t-test was used to compare oral health-related knowledge (K) and behaviour, attitude and self-efficacy (BAS) scores. Of the initial 219 respondents, 154 (response rate between 40% and 35.8%, with attrition rate of 29.7% from baseline to repeat) returned completed questionnaires at post-test (M=8.5 months, range=6.5-11 months). Control and intervention groups were comparable for general training, employment and demographic variables. In the intervention group, mean Knowledge Index score rose from K=7.2 to K=7.9 (P<0.001) and mean BAS scale score rose from BAS=4.7 to BAS=5.4 (P<0.001). There was no statistically significant increase in mean scores from test (K=7.0, BAS=4.7) to post-test (K=7.2, BAS=4.9) for the control group. Mean scores regarding knowledge, attitude, self-efficacy and reported behaviour increased significantly at 8.5 months in staff where training was provided. The results indicate that a multi-tiered training programme improved knowledge, attitude, self-efficacy and reported behaviour amongst staff caring for people with ID.

 


Using intervention mapping to develop a home-based parental-supervised toothbrushing intervention for young children.

K Gray-Burrows, P Day, Z Marshman, E Aliakbari, S Prady, R McEachan

Implementation science : IS [11:61] (2016)

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Dental caries in young children is a major public health problem impacting on the child and their family in terms of pain, infection and substantial financial burden on healthcare funders. In the UK, national guidance on the prevention of dental caries advises parents to supervise their child's brushing with fluoride toothpaste until age 7. However, there is a dearth of evidence-based interventions to encourage this practice in parents. The current study used intervention mapping (IM) to develop a home-based parental-supervised toothbrushing intervention to reduce dental caries in young children. The intervention was developed using the six key stages of the IM protocol: (1) needs assessment, including a systematic review, qualitative interviews, and meetings with a multi-disciplinary intervention development group; (2) identification of outcomes and change objectives following identification of the barriers to parental-supervised toothbrushing (PSB), mapped alongside psychological determinants outlined in the Theoretical Domains Framework (TDF); (3) selection of methods and practical strategies; (4) production of a programme plan; (5) adoption and implementation and (6) Evaluation. The comprehensive needs assessment highlighted key barriers to PSB, such as knowledge, skills, self-efficacy, routine setting and behaviour regulation and underlined the importance of individual, social and structural influences. Parenting skills (routine setting and the ability to manage the behaviour of a reluctant child) were emphasised as critical to the success of PSB. The multi-disciplinary intervention development group highlighted the need for both universal and targeted programmes, which could be implemented within current provision. Two intervention pathways were developed: a lower cost universal pathway utilising an existing national programme and an intensive targeted programme delivered via existing parenting programmes. A training manual was created to accompany each intervention to ensure knowledge and standardise implementation procedures. PSB is a complex behaviour and requires intervention across individual, social and structural levels. IM, although a time-consuming process, allowed us to capture this complexity and allowed us to develop two community-based intervention pathways covering both universal and targeted approaches, which can be integrated into current provision. Further research is needed to evaluate the acceptability and sustainability of these interventions.

 


A Brief Self-Regulatory Intervention Increases Dental Flossing in Adolescent Girls.

Maryam Gholami, Nina Knoll, Ralf Schwarzer

International journal of behavioral medicine [22:645-51] (2015)

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Oral diseases such as dental caries, periodontal disease, and tooth loss are a considerable public health problem. A review of the epidemiological data from many countries indicates that a global increase in dental caries prevalence affects children as well as adults. Despite the improvement in oral health of children in the last few decades, tooth decay remains one of the most common childhood diseases in both industrialized and developing countries. The study evaluates the effects of a self-regulatory intervention to increase dental flossing among adolescents and examines the mediating mechanisms underlying behavioral changes. A cluster randomized controlled trial compared a brief intervention arm with a control arm in 166 girls aged 11-15 years. Planning, self-efficacy, and behavioral intention were specified as mediators between treatment conditions and follow-up dental flossing frequency. At baseline, the intervention group received theory-guided materials on oral hygiene. Four weeks later, changes in behavior and social-cognitive variables were assessed. The brief self-regulatory intervention led to an increase in dental flossing and social-cognitive constructs. A sequential mediator model was identified in which first changes in intention and afterwards changes in self-efficacy mediated between treatment conditions and behavioral outcomes. Intention formation and self-efficacy seem to play an instrumental role in the mechanism that facilitates dental flossing among adolescent girls. Oral self-care interventions should consider the application of intention formation strategies combined with building confidence in one's ability to adhere to the regimen.

 


Efficacy of a brief behavioral intervention to promote condom use among female sex workers in Tijuana and Ciudad Juarez, Mexico.

Thomas Patterson, Brent Mausbach, Remedios Lozada, Hugo Staines-Orozco, Shirley Semple, Miguel Fraga-Vallejo, Prisci Orozovich, Daniela Abramovitz, Adela de la Torre, Hortensia Amaro, Gustavo Martinez, Carlos Magis-Rodríguez, Steffanie Strathdee

American journal of public health [98:2051-7] (2008)

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We examined the efficacy of a brief behavioral intervention to promote condom use among female sex workers in Tijuana and Ciudad Juarez, Mexico. We randomized 924 female sex workers 18 years or older without known HIV infection living in Tijuana and Ciudad Juarez who had recently had unprotected sex with clients to a 30-minute behavioral intervention or a didactic control condition. At baseline and 6 months, women underwent interviews and testing for HIV, syphilis, gonorrhea, and chlamydia. We observed a 40% decline in cumulative sexually transmitted illness incidence (P = .049) in the intervention group. Incidence density for the intervention versus control groups was 13.8 versus 24.92 per 100 person-years for sexually transmitted illnesses combined (P = .034) and 0 versus 2.01 per 100 person-years for HIV (P < .001). There were concomitant increases in the number and percentage of protected sex acts and decreases in the number of unprotected sex acts with clients (P < .05). This brief behavioral intervention shows promise in reducing HIV and sexually transmitted illness risk behaviors among female sex workers and may be transferable to other resource-constrained settings.

 



Multicentre RCT and economic evaluation of a psychological intervention together with a leaflet to reduce risk behaviour amongst men who have sex with men (MSM) prescribed post-exposure prophylaxis for HIV following sexual exposure (PEPSE): a protocol.

Carrie Llewellyn, Charles Abraham, Alec Miners, Helen Smith, Alex Pollard, Paul Benn, Martin Fisher

BMC infectious diseases [12:70] (2012)

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Post-exposure prophylaxis (PEP) following sexual exposure to HIV has been recommended as a method of preventing HIV infection in the UK. Men who have sex with men (MSM) are the group most affected by HIV in the UK and their sexual risk taking behaviour is reported to be increasing. One-to-one behavioural interventions, such as motivational interviewing (MI) have been recommended to reduce HIV in high risk groups. The Information, Motivation and Behavioral skills (IMB) model has been shown to provide a good basis for understanding and predicting HIV-relevant health behaviour and health behaviour change, however the IMB has yet to be applied to PEP after risky sexual exposure. The primary aim of this trial is to examine the impact of MI augmented with information provision and behavioural skills building (informed by the IMB Model), over and above usual care, on risky sexual behaviour in MSM prescribed PEP after potential sexual exposure. A secondary aim of this research is to examine the impact of the intervention on adherence to PEP. This study will also provide estimates of the cost-effectiveness of the intervention. A manualised parallel group randomised controlled trial with economic evaluation will be conducted. The primary outcome is the proportion of risky sexual practices. Secondary outcomes include: i) Levels of adherence to PEP treatment; ii) Number of subsequent courses of PEP; iii) Levels of motivation to avoid risky sexual behaviours; iv) Levels of HIV risk-reduction information/knowledge; v) Levels of risk reduction behavioural skills; vi) Diagnosis of anal gonorrhoea, Chlamydia and/or HIV. 250 participants will be asked to self-complete a questionnaire at four time points during the study (at 0,3,6,12 months). The intervention will consist of a two-session, fixed duration, telephone administered augmented MI intervention based on the IMB model. A newly developed treatment manual will guide the selection of persuasive communication strategies as appropriate for each participant and will be based on underlying change mechanisms specified by the IMB theoretical framework. Information provision and skills building will also be included in the intervention package through the use of information leaflets and tailored action plans. Fidelity of intervention delivery will be assessed. The results from this NIHR funded study will identify whether it is appropriate and cost-effective to intervene using one-to-one telephone calls with MSM seeking PEP. If the intervention is effective, further work will be needed on training staff to deliver the intervention competently. UKCRN ID:11436; ISRCTN00746242.

 


Comparing theory-based condom interventions: health belief model versus theory of planned behavior.

Erika Montanaro, Angela Bryan

Health psychology : official journal of the Division of Health Psychology, American Psychological Association [33:1251-60] (2014)

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This study sought to experimentally manipulate the core constructs of the Health Belief Model (HBM) and the Theory of Planned Behavior (TPB) in order to compare the success of interventions to increase preparatory condom use behavior (i.e., purchasing condoms, talking to a boyfriend or girlfriend about using condoms, and carrying condoms) based on these theories. A total of 258 participants were randomly assigned to one of three computer-based interventions (HBM, TPB, or information-only control). A total of 204 (79.1%) completed follow-up assessments 1 month later. Regression analyses were conducted to determine which set of theoretical constructs accounted for the most variance in behavior at baseline. A series of structural equation models were estimated to determine which constructs were the "active ingredients" of change. The TPB accounted for 32.8% of the variance in risky sexual behavior at baseline, while the HBM only explained 1.6% of the variance. Mediational analyses revealed differential intervention effects on perceived susceptibility, perceived benefits, and attitudes toward condom use. However, it was attitudes toward condom use and condom use self-efficacy that were associated with intentions, which then predicted preparatory condom use behavior at follow-up. Except for attitudes, the mediators that were successfully manipulated by the interventions (i.e., perceived susceptibility, perceived severity, and attitudes) were not the same constructs that predicted intentions (i.e., attitudes and condom use self-efficacy), and subsequently predicted behavior. This suggests that the constructs that explain behavior are not the same as those that produce behavior change.

 


SafeTalk, a multicomponent, motivational interviewing-based, safer sex counseling program for people living with HIV/AIDS: a qualitative assessment of patients' views.

Carol Golin, Rebecca Davis, Sarahmona M Przybyla, Beth Fowler, Sharon Parker, Jo Anne Earp, E Byrd Quinlivan, Seth Kalichman, Shilpa Patel, Catherine Grodensky

AIDS patient care and STDs [24:237-45] (2010)

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With the continued transmission of HIV each year, novel approaches to HIV prevention are needed. Since 2003, the U.S. HIV prevention focus has shifted from primarily targeting HIV-negative at-risk persons to including safer sex programs for people already infected with HIV. At least 20-30% of people infected with HIV engage in risky sexual practices. Based on these data, policymakers have recommended that interventionists develop strategies to help HIV-infected people reduce their risky sexual behaviors. In the past, the few safer sex interventions that targeted HIV-infected people met with limited success because they basically adapted strategies previously used with HIV-uninfected individuals. In addition, often these adaptations did not address issues of serostatus disclosure, HIV stigma, or motivation to protect others from HIV. We had previously tested, in a demonstration project named the Start Talking About Risks (STAR) Program, a monthly three-session motivational interviewing (MI)-based intervention to help people living with HIV practice safer sex. In this study, we refined that program by enhancing its frequency and intensity and adding written and audio components to support the counseling. We theorized that an intervention such as MI, which is tailored to each individual's circumstances more than standardized prevention messages, would be more successful when supplemented with other components. We qualitatively assessed participants' perceptions, reactions, and preferences to the refined prevention with positives counseling program we called SafeTalk and learned that participants found the SafeTalk MI counseling and educational materials appealing, understandable, and relevant to their lives.

 


A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

Kara Burns, Patrick Keating, Caroline Free

BMC public health [16:778] (2016)

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Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom use. Finally, one trial showed that collection of sexual health information using mobile technology was acceptable. The findings suggest interventions delivered by SMS interventions can increase uptake of sexual health services and STI testing. High quality trials of interventions using standardised objective measures and employing a wider range of behavioural change techniques are needed to assess if interventions delivered by mobile phone can alter safer sex behaviours carried out between couples and reduce STIs.

 


Integrating psychological theory into the design of an online intervention for sexual health: the sexunzipped website.

Kenneth Carswell, Ona McCarthy, Elizabeth Murray, Julia Bailey

JMIR research protocols [1:e16] (2012)

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The Internet can provide a confidential and convenient medium for sexual health promotion for young people. This paper describes the development of an interactive, theory-based website (Sexunzipped) aimed at increasing safe sexual behavior of young people, as well as an outline of the evaluation protocol. The website focuses on safer sex, relationships, and sexual pleasure. An overview of the site is provided, including a description of the theoretical constructs which form the basis of the site development. An integrated behavioral model was chosen as the guiding theory for the Sexunzipped intervention. A randomized trial design will be used to evaluate the site quantitatively. The content of the site is described in detail with examples of the main content types: information pages, quizzes, and decision-making activities. We describe the protocol for quantitative evaluation of the website using a randomized trial design and discuss the principal challenges involved in developing the site, including the challenge of balancing the requirements of theory with young people's views on website content and design. Considerations for future interventions are discussed. Developing an online behavior-change intervention is costly and time consuming. Given the large public health potential, the cost involved in developing online interventions, and the need for attractive design, future interventions may benefit from collaborating with established sites that already have a user base, a brand, and a strong Internet presence. It is vital to involve users in decisions about intervention content, design, and features, paying attention to aspects that will attract and retain users' interest. A central challenge in developing effective Internet-based interventions for young people is to find effective ways to operationalize theory in ways that address the views and perspectives of young people.

 



Talking parents, healthy teens: a worksite-based program for parents to promote adolescent sexual health.

Karen Eastman, Rosalie Corona, Mark Schuster

Preventing chronic disease [3:A126] (2006)

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Parents play an important role in the sexual health of their adolescent children. Based on previous research, formative research, and theories of behavioral change, we developed Talking Parents, Healthy Teens, an intervention designed to help parents improve communication with their adolescent children, promote healthy adolescent sexual development, and reduce adolescent sexual risk behaviors. We conduct the parenting program at worksites to facilitate recruitment and retention of participants. The program consists of 8 weekly 1-hour sessions during the lunch hour. In this article, we review the literature that identifies parental influences on adolescent sexual behavior, summarize our formative research, present the theoretical framework we used to develop Talking Parents, Healthy Teens, describe the program's components and intervention strategies, and offer recommendations based on our experiences developing the program. By targeting parents at their worksites, this program represents an innovative approach to promoting adolescent sexual health. This article is intended to be helpful to health educators and clinicians designing programs for parents, employers implementing health-related programs, and researchers who may consider designing and evaluating such worksite-based programs.

 


The Men's Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men.

Julia Bailey, Rosie Webster, Rachael Hunter, Mark Griffin, Nicholas Freemantle, Greta Rait, Claudia Estcourt, Susan Michie, Jane Anderson, Judith Stephenson, Makeda Gerressu, Chee Siang Ang, Elizabeth Murray

Health technology assessment (Winchester, England) [20:1-124] (2016)

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This report details the development of the Men's Safer Sex website and the results of a feasibility randomised controlled trial (RCT), health economic assessment and qualitative evaluation. (1) Develop the Men's Safer Sex website to address barriers to condom use; (2) determine the best design for an online RCT; (3) inform the methods for collecting and analysing health economic data; (4) assess the Sexual Quality of Life (SQoL) questionnaire and European Quality of Life-5 Dimensions, three-level version (EQ-5D-3L) to calculate quality-adjusted life-years (QALYs); and (5) explore clinic staff and men's views of online research methodology. (1) Website development: we combined evidence from research literature and the views of experts (n = 18) and male clinic users (n = 43); (2) feasibility RCT: 159 heterosexually active men were recruited from three sexual health clinics and were randomised by computer to the Men's Safer Sex website plus usual care (n = 84) or usual clinic care only (n = 75). Men were invited to complete online questionnaires at 3, 6, 9 and 12 months, and sexually transmitted infection (STI) diagnoses were recorded from clinic notes at 12 months; (3) health economic evaluation: we investigated the impact of using different questionnaires to calculate utilities and QALYs (the EQ-5D-3L and SQoL questionnaire), and compared different methods to collect resource use; and (4) qualitative evaluation: thematic analysis of interviews with 11 male trial participants and nine clinic staff, as well as free-text comments from online outcome questionnaires. (1) Software errors and clinic Wi-Fi access presented significant challenges. Response rates for online questionnaires were poor but improved with larger vouchers (from 36% with £10 to 50% with £30). Clinical records were located for 94% of participants for STI diagnoses. There were no group differences in condomless sex with female partners [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI) 0.52 to 1.96]. New STI diagnoses were recorded for 8.8% (7/80) of the intervention group and 13.0% (9/69) of the control group (IRR 0.75, 95% CI 0.29 to 1.89). (2) Health-care resource data were more complete using patient files than questionnaires. The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included. (3) The pilot RCT fitted well around clinical activities but 37% of the intervention group did not see the Men's Safer Sex website and technical problems were frustrating. Men's views of the Men's Safer Sex website and research procedures were largely positive. It would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome; however, technical errors and a poor response rate limited the collection of online self-reported outcomes. The next steps are (1) to optimise software for online trials, (2) to find the best ways to integrate digital health promotion with clinical services, (3) to develop more precise methods for collecting resource use data and (4) to work out how to overcome barriers to digital intervention testing and implementation in the NHS. Current Controlled Trials ISRCTN18649610. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 91. See the NIHR Journals Library website for further project information.

 


The effects of two AIDS risk-reduction interventions on heterosexual college women's AIDS-related knowledge, attitudes and condom use.

C Ploem, ES Byers

Journal of psychology & human sexuality [9:1-24] (1997)

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An intervention combining AIDS information with condom eroticization, condom normalization, and communication skills training was found to increase both AIDS-related knowledge and condom use among Canadian college students. 112 unmarried female undergraduates (mean age, 18 years) were randomly assigned to this combination intervention (n = 49), an information-only intervention (n = 44), or a pre-test/post-test control group (n = 19). 80% of students had engaged in vaginal intercourse and 14% in anal intercourse. 84% of coitally active women had engaged in unprotected intercourse in the past year and 48% had not used condoms consistently with any sexual partner. Condom use in the pre-intervention period was associated with positive attitudes toward the method and the perception that condom use was normative among peers. One month after the interventions, both the combination and information groups, but not controls, showed an increase over baseline in AIDS-related knowledge. However, among the 36 students who were coitally active in the 1-month periods before and after the intervention, only the combination intervention was associated with increased condom use. In the combination group, the percentage of episodes of intercourse protected by condoms increased from an average of 21.8% in the month preceding the study to 50% during the 4-week follow-up period. Due to the small sample size and design of the study, it was not possible to determine which component of the multifaceted educational intervention was most responsible for this change.

 


A behavioural intervention to reduce persistence of bacterial vaginosis among women who report sex with women: results of a randomised trial.

Jeanne Marrazzo, Katherine Thomas, Kathleen Ringwood

Sexually transmitted infections [87:399-405] (2011)

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Bacterial vaginosis (BV) is common in lesbians, and treatment fails in up to 28%. Risks include sexual behaviours that transmit vaginal fluid. The authors measured efficacy of a behavioural intervention to reduce sexual transfer of vaginal fluid between female sex partners in reducing BV persistence. Women aged 16-35 years with BV who reported sex with women (prior year) were eligible. Participants were randomised to intervention (motivational interviewing designed to reduce sharing of vaginal fluid on hands or sex toys post-treatment, by provision of condoms, gloves and water-based lubricant) or control (general STI education) arms. All were treated with vaginal metronidazole and underwent computer-assisted self-interview to ascertain sexual behaviours, with test-of-cure at 30 days. Of 129 women with BV, 108 (84%) were eligible; 89 (69%) agreed to enrol. 43 were randomised to control and 46 to intervention; 81 (91%) returned for test-of-cure. BV persisted in 12 (27.9%) of 43 women in intervention and 8 (21.1%) of 38 women in control arms (p1/40.6). Digital-vaginal sex was common post-treatment (50% intervention and 68% control); women randomised to the intervention were less likely to report receptive digital-vaginal sex without gloves than control (31% vs 61%; p1/40.01), without reported lower frequency of other sexual practices. Shared vaginal use of sex toys was infrequent. Although the intervention effected a significant increase in glove use during digital-vaginal sex post-BV treatment, this was not associated with reduction in BV persistence. Shared use of vaginal sex toys was infrequent, suggesting that other mechanisms promote BV in lesbians.

 



HIV/STD risk reduction interventions for African American and Latino adolescent girls at an adolescent medicine clinic: a randomized controlled trial.

John Jemmott, Loretta Sweet Jemmott, Paula Braverman, Geoffrey Fong

Archives of pediatrics & adolescent medicine [159:440-9] (2005)

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Adolescent girls in the United States and around the world are at a heightened risk for sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV). To determine the efficacy of a skill-based HIV/STD risk-reduction intervention in reducing self-reported unprotected sexual intercourse among African American and Latino adolescent girls. Randomized controlled trial with 3-, 6-, and 12-month follow-ups. Sexually experienced African American and Latino adolescent girls recruited from the adolescent medicine clinic of a children's hospital serving a low-income inner-city community (N = 682, mean age, 15.5 years); 88.6% were retained at the 12-month follow-up. Three 250-minute interventions based on cognitive-behavioral theories and elicitation research: an information-based HIV/STD intervention provided information necessary to practice safer sex; a skill-based HIV/STD intervention provided information and taught skills necessary to practice safer sex; or a health-promotion control intervention concerned with health issues unrelated to sexual behavior. Primary outcome measure was self-reported frequency of unprotected sexual intercourse; secondary outcomes included the frequency of sexual intercourse while intoxicated, the number of sexual partners, biologically confirmed STDs, and theoretical mediator variables, including the intention to use condoms, beliefs about using condoms, and condom-use knowledge. No differences between the information intervention and the health control intervention were statistically significant. Skills-intervention participants (mean [SE], 2.27 [0.81]) reported less unprotected sexual intercourse at the 12-month follow-up than did information-intervention participants (mean [SE], 4.04 [0.80]; P = .03), or health control-intervention participants (mean [SE], 5.05 [0.81]; P = .002). At the 12-month follow-up, skills-intervention participants (mean [SE], 0.91 [0.05]) reported fewer sexual partners (P = .04) compared with health control-intervention participants (mean [SE], 1.04 [0.05]) and were less likely to test positive for STD (mean [SE], 10.5% [2.9%]) than were health control-intervention participants (mean [SE], 18.2% [2.8%]; P = .05). No differences in the frequency of unprotected sexual intercourse, the number of partners, or the rate of STD were observed at the 3- or 6-month follow-up between skill-intervention participants and information-intervention or health control-intervention participants. Skill-based HIV/STD interventions can reduce sexual risk behaviors and STD rate among African American and Latino adolescent girls in clinic settings.

 




Defining the Content of an Online Sexual Health Intervention: The MenSS Website.

Rosie Webster, Makeda Gerressu, Susan Michie, Claudia Estcourt, Jane Anderson, Chee Siang Ang, Elizabeth Murray, Greta Rait, Judith Stephenson, Julia Bailey

JMIR research protocols [4:e82] (2015)

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Health promotion and risk reduction are essential components of sexual health care. However, it can be difficult to prioritize these within busy clinical services. Digital interventions may provide a new method for supporting these. The MenSS (Men's Safer Sex) website is an interactive digital intervention developed by a multidisciplinary team, which aims to improve condom use in men who have sex with women (MSW). This paper describes the content of this intervention, and the rationale for it. Content was informed by a literature review regarding men's barriers to condom use, workshops with experts in sexual health and technology (N=16) and interviews with men in sexual health clinics (N=20). Data from these sources were analyzed thematically, and synthesized using the Behavior Change Wheel framework. The MenSS intervention is a website optimized for delivery via tablet computer within a clinic waiting room setting. Key targets identified were condom use skills, beliefs about pleasure and knowledge about risk. Content was developed using behavior change techniques, and interactive website features provided feedback tailored for individual users. This paper provides a detailed description of an evidence-based interactive digital intervention for sexual health, including how behavior change techniques were translated into practice within the design of the MenSS website. Triangulation between a targeted literature review, expert workshops, and interviews with men ensured that a range of potential influences on condom use were captured.

 


Randomized trial of group interventions to reduce HIV/STD risk and change theoretical mediators among detained adolescents.

Sarah Schmiege, Michelle Broaddus, Michael Levin, Angela Bryan

Journal of consulting and clinical psychology [77:38-50] (2009)

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Criminally involved adolescents engage in high levels of risky sexual behavior and alcohol use, and alcohol use may contribute to lack of condom use. Detained adolescents (n = 484) were randomized to (1) a theory-based sexual risk reduction intervention (GPI), (2) the GPI condition with a group-based alcohol risk reduction motivational enhancement therapy component (GPI + GMET), or (3) an information-only control (INFO). All interventions were presented in same-sex groups in single sessions lasting from 2 to 4 hr. Changes to putative theoretical mediators (attitudes, perceived norms, self-efficacy, and intentions) were measured immediately following intervention administration. The primary outcomes were risky sexual behavior and sexual behavior while drinking measured 3 months later (65.1% retention). The GPI + GMET intervention demonstrated superiority over both other conditions in influencing theoretical mediators and over the INFO control in reducing risky sexual behavior. Self-efficacy and intentions were significant mediators between condition and later risky sexual behavior. This study contributes to an understanding of harm reduction among high-risk adolescents and has implications for understanding circumstances in which the inclusion of GMET components may be effective.

 


Effectiveness of HIV/STD sexual risk reduction groups for women in substance abuse treatment programs: results of NIDA Clinical Trials Network Trial.

Susan Tross, Aimee NC Campbell, Lisa Cohen, Donald Calsyn, Martina Pavlicova, Gloria Miele, Mei-Chen Hu, Louise Haynes, Nancy Nugent, Weijin Gan, Mary Hatch-Maillette, Raul Mandler, Paul McLaughlin, Nabila El-Bassel, Paul Crits-Christoph, Edward Nunes

Journal of acquired immune deficiency syndromes (1999) [48:581-9] (2008)

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Because drug-involved women are among the fastest growing groups with AIDS, sexual risk reduction intervention for them is a public health imperative. To test effectiveness of HIV/STD safer sex skills building (SSB) groups for women in community drug treatment. Randomized trial of SSB versus standard HIV/STD Education (HE); assessments at baseline, 3 and 6 months. Women recruited from 12 methadone or psychosocial treatment programs in Clinical Trials Network of National Institute on Drug Abuse. Five hundred fifteen women with >or=1 unprotected vaginal or anal sex occasion (USO) with a male partner in the past 6 months were randomized. In SSB, five 90-minute groups used problem solving and skills rehearsal to increase HIV/STD risk awareness, condom use, and partner negotiation skills. In HE, one 60-minute group covered HIV/STD disease, testing, treatment, and prevention information. Number of USOs at follow-up. A significant difference in mean USOs was obtained between SSB and HE over time (F = 67.2, P < 0.0001). At 3 months, significant decrements were observed in both conditions. At 6 months, SSB maintained the decrease and HE returned to baseline (P < 0.0377). Women in SSB had 29% fewer USOs than those in HE. Skills building interventions can produce ongoing sexual risk reduction in women in community drug treatment.

 


Pilot study of a brief intervention based on the theory of planned behaviour and self-identity to increase chlamydia testing among young people living in deprived areas.

Amy Booth, Paul Norman, Elizabeth Goyder, Peter Harris, Michael Campbell

British journal of health psychology [19:636-51] (2014)

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This study sought to estimate the effects of a novel intervention, compared with usual chlamydia testing promotion, on chlamydia test uptake and intentions among young people living in deprived areas. The intervention was based on the theory of planned behaviour, augmented with self-identity, and targeted the significant predictors of chlamydia testing intentions identified in the previous research. Cluster randomization was used to allocate college tutor groups (intervention n = 10; control n = 11) to the intervention or control group. The sample comprised 253 participants (intervention n = 145, control n = 108). The primary outcome was test offer uptake at the end of the session. Other outcomes measured at immediate follow-up were intention, attitude, subjective norm, perceived behavioural control, and self-identity. Generalized estimating equations, controlling for cluster effects and sexual activity, found a small but non-significant effect of condition on test offer uptake, OR = 1.65 (95% CI 0.70, 3.88) p = .25, with 57.5% of intervention participants accepting the offer of a test compared with 40.2% of control participants. Using the same analysis procedure, small-to-medium intervention effects were found on other outcome variables, including a significant effect on attitudes towards chlamydia testing, OR = 1.37 (95% CI 1.00, 1.87), p = .05. The results provide encouraging initial evidence that this theory-based intervention, targeting the key determinants of chlamydia testing, may help to improve chlamydia testing uptake in a high-risk group. They support the conduct of a larger trial to evaluate the effectiveness of the intervention. What is already known on this subject? Young people living in areas of increased socio-economic deprivation have been identified as a high-risk group for chlamydia. Previous research within an extended model of the theory of planned behaviour (TPB) found that attitude, subjective norm, perceived behavioural control, and self-identity all significantly predicted chlamydia testing intentions in this high-risk group. What does this study add? Development and testing of a novel, TPB-based intervention targeting predictors of chlamydia testing intentions. The intervention led to significantly more positive attitudes towards chlamydia testing. Preliminary indication that a TPB-based intervention may help to improve chlamydia testing in a high-risk group.

 




Preventing college women's sexual victimization through parent based intervention: a randomized controlled trial.

Maria Testa, Joseph Hoffman, Jennifer Livingston, Rob Turrisi

Prevention science : the official journal of the Society for Prevention Research [11:308-18] (2010)

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A randomized controlled trial, using parent-based intervention (PBI) was designed to reduce the incidence of alcohol-involved sexual victimization among first-year college students. The PBI, adapted from Turrisi et al. (2001), was designed to increase alcohol-specific and general communication between mother and daughter. Female graduating high school seniors and their mothers were recruited from the community and randomly assigned to one of four conditions: Alcohol PBI (n = 305), Enhanced Alcohol + Sex PBI (n = 218), Control (n = 288) or Unmeasured Control (n = 167). Mothers in the intervention conditions were provided an informational handbook and encouraged to discuss its contents with their daughters prior to college matriculation. Consistent with hypotheses, PBI, either standard or enhanced, was associated with lower incidence of incapacitated rape in the first year of college relative to controls. Path analysis revealed support for a hypothesized indirect effects model, by which intervention increased mother-daughter communication, which predicted lower frequency of first semester heavy episodic drinking, resulting in lower rates of alcohol-involved sexual victimization in the first year of college.

 


Can safer-sex promotion leaflets change cognitive antecedents of condom use? An experimental evaluation.

Barbara Krahé, Charles Abraham, Renate Scheinberger-Olwig

British journal of health psychology [10:203-20] (2005)

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An experimental evaluation of a safer sex promotion leaflet was undertaken to assess its capacity to change antecedent cognitions of condom use. The leaflet was identified in a previous study as addressing research-based cognitive antecedents of condom use. A pre-post-test experimental study including three conditions was conducted: (a) presentation of the leaflet; (b) presentation of the leaflet plus incentive for systematic processing; (c) no-leaflet control. The leaflet was evaluated in terms of its capacity to change eight cognitive correlates of condom use identified in a recent meta-analysis. The sample consisted of 230 tenth-grade students. Following baseline assessments, leaflet-induced change was measured immediately following the intervention and at a follow up 4 weeks post-intervention. The target leaflet alone did not result in significant changes in the cognitive antecedents of condom use compared with the control condition. However, in combination with an incentive for systematic processing, the target leaflet had a greater impact on cognitive antecedents than the no-leaflet control condition. The findings are discussed with regard to the development and evaluation of research-based health-promotion materials.

 






Assessing the effectiveness of peer-facilitated interventions addressing high-risk drinking among judicially mandated college students.

M Dolores Cimini, Matthew Martens, Mary Larimer, Jason Kilmer, Clayton Neighbors, Joseph Monserrat

Journal of studies on alcohol and drugs. Supplement (2009)

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This study examined the effectiveness of three peer-facilitated brief alcohol interventions-small group motivational interviewing, motivationally enhanced peer theater, and an interactive alcohol-education program-with students engaging in high-risk drinking who were referred for alcohol policy violations. Undergraduate students referred for alcohol policy violations (N = 695) at a large northeastern public university were randomized to one of the three conditions. Six-month follow-up data were collected on drinking frequency and quantity, negative consequences, use of protective behaviors, and perceptions of peers' drinking norms. There were no statistically significant overall pre-post effects or treatment effects. However, exploratory analyses indicated that decreases in perceived norms and increases in use of protective behavioral strategies were associated with reductions in alcohol use and alcohol-related problems at follow-up (p < .01). The presence of nonsignificant pre-post or main effects is, in part, consistent with recent research indicating that sanctioned college students may immediately reduce drinking in response to citation and that brief interventions may not contribute to additional behavioral change. The presence of statistically significant correlations between alcohol use and related problems with corrections in norms misperceptions and increased use of protective behaviors at the individual level holds promise for both research and practice. The integration of elements addressing social norms and use of protective behaviors within brief cognitive-behavioral intervention protocols delivered by trained peer facilitators warrants further study using randomized clinical trials.

 



A randomized controlled trial of event-specific prevention strategies for reducing problematic drinking associated with 21st birthday celebrations.

Clayton Neighbors, Christine Lee, David Atkins, Melissa Lewis, Debra Kaysen, Angela Mittmann, Nicole Fossos, Irene Geisner, Cheng Zheng, Mary Larimer

Journal of consulting and clinical psychology [80:850-62] (2012)

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While research has documented heavy drinking practices and associated negative consequences of college students turning 21, few studies have examined prevention efforts aimed at reducing high-risk drinking during 21st birthday celebrations. The present study evaluated the comparative efficacy of a general prevention effort (i.e., Brief Alcohol Screening and Intervention for College Students, or BASICS) and event-specific prevention in reducing 21st birthday drinking and related negative consequences. Furthermore, this study evaluated inclusion of peers in interventions and mode of intervention delivery (i.e., in-person vs. via the Web). Participants included 599 college students (46% male): men who intended to consume at least 5 drinks and women who intended to consume at least 4 drinks on their 21st birthday. After completing a screening/baseline assessment approximately 1 week before turning 21, participants were randomly assigned to 1 of 6 conditions: 21st birthday in-person BASICS, 21st birthday web BASICS, 21st birthday in-person BASICS plus friend intervention, 21st birthday web BASICS plus friend intervention, BASICS, or an attention control. A follow-up assessment was completed approximately 1 week after students' birthdays. Results indicated a significant intervention effect for BASICS in reducing blood alcohol content reached and number of negative consequences experienced. All 3 in-person interventions reduced negative consequences experienced. Results for the web-based interventions varied by drinking outcome and whether a friend was included. Overall, results provide support for both general intervention and ESP approaches across modalities for reducing extreme drinking and negative consequences associated with turning 21. These results suggest there are several promising options for campuses seeking to reduce both use and negative consequences associated with 21st birthday celebrations.

 



Optimizing personalized normative feedback: the use of gender-specific referents.

Melissa Lewis, Clayton Neighbors

Journal of studies on alcohol and drugs [68:228-37] (2007)

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Many brief interventions include personalized normative feedback (PNF) using gender-specific or gender-neutral referents. Several theories suggest that information pertaining to more socially proximal referents should have greater influence on one's behavior compared with more socially distal referents. The current research evaluated whether gender specificity of the normative referent employed in PNF related to intervention efficacy. Following baseline assessment, 185 college students (45.2% women) were randomly assigned to one of three intervention conditions: gender-specific feedback, gender-neutral feedback, or assessment-only control. Immediately after completing measures of perceived norms, alcohol consumption, and gender identity, participants in the gender-neutral and gender-specific intervention conditions were provided with computerized information detailing their own drinking behavior, their perceptions of student drinking, and actual student drinking. After a 1-month follow-up, the results indicated that normative feedback was effective in changing perceived norms and reducing alcohol consumption for both intervention groups for women and men. The results provide support, however, for changes in perceived gender-specific norms as a mediator of the effects of normative feedback on reduced drinking behavior for women only. Additionally, gender-specific feedback was found to be more effective for women higher in gender identity, relative to the gender-neutral feedback. A post-assessment follow-up telephone survey administered to assess potential demand characteristics corroborated the intervention effects. Results extend previous research documenting efficacy of computer delivered PNF. Gender specificity and gender identity appear to be important elements to consider for PNF intervention efficacy for women.

 



Does changing social influence engender changes in alcohol intake? A meta-analysis.

Andrew Prestwich, Ian Kellar, Mark Conner, Rebecca Lawton, Peter Gardner, Liz Turgut

Journal of consulting and clinical psychology [84:845-60] (2016)

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Past research has suggested that social influences on drinking can be manipulated with subsequent reductions in alcohol intake. However, the experimental evidence for this and the best strategies to positively change these social influences have not been meta-analyzed. This research addressed these gaps. Randomized controlled trials testing social influence-based interventions on adults' drinking were systematically reviewed and meta-analyzed. The behavior change techniques used in each study were coded and the effect sizes showing the impact of each intervention on (a) social influence and (b) alcohol intake were calculated. Metaregressions identified the association between these effect sizes, as well as the effect of specific behavior change techniques on social influences. Forty-one studies comprising 17,445 participants were included. Changes in social influences were significantly associated with changes in alcohol intake. However, even moderate-to-large changes in social influences corresponded with only a small change in drinking behavior and changing social influences did not reduce alcohol-related problems. Providing normative information about others' behavior and experiences was the most effective technique to change social influences. Social influences and normative beliefs can be changed in drinkers, particularly by providing normative information about how much others' drink. However, even generating large changes in these constructs are likely to engender only small changes in alcohol intake. (PsycINFO Database Record

 


Computerized versus motivational interviewing alcohol interventions: impact on discrepancy, motivation, and drinking.

James Murphy, Ashley Dennhardt, Jessica Skidmore, Matthew Martens, Meghan McDevitt-Murphy

Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors [24:628-39] (2010)

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The authors conducted two randomized clinical trials with ethnically diverse samples of college student drinkers in order to determine (a) the relative efficacy of two popular computerized interventions versus a more comprehensive motivational interview approach (BASICS) and (b) the mechanisms of change associated with these interventions. In Study 1, heavy drinking participants recruited from a student health center (N = 74, 59% women, 23% African American) were randomly assigned to receive BASICS or the Alcohol 101 CD-ROM program. BASICS was associated with greater post-session motivation to change and self-ideal and normative discrepancy relative to Alcohol 101, but there were no group differences in the primary drinking outcomes at 1-month follow-up. Pre to post session increases in motivation predicted lower follow-up drinking across both conditions. In Study 2, heavy drinking freshman recruited from a core university course (N = 133, 50% women, 30% African American) were randomly assigned to BASICS, a web-based feedback program (e-CHUG), or assessment-only. BASICS was associated with greater post-session self-ideal discrepancy than e-CHUG, but there were no differences in motivation or normative discrepancy. There was a significant treatment effect on typical weekly and heavy drinking, with participants in BASICS reporting significantly lower follow-up drinking relative to assessment only participants. In Study 2, change in the motivation or discrepancy did not predict drinking outcomes. Across both studies, African American students assigned to BASICS reported medium effect size reductions in drinking whereas African American students assigned to Alcohol 101, e-CHUG, or assessment did not reduce their drinking.

 


Personalized mailed feedback for college drinking prevention: a randomized clinical trial.

Mary Larimer, Christine Lee, Jason Kilmer, Patricia Fabiano, Christopher Stark, Irene Geisner, Kimberly Mallett, Ty Lostutter, Jessica Cronce, Maggie Feeney, Clayton Neighbors

Journal of consulting and clinical psychology [75:285-93] (2007)

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The current study was designed to evaluate the efficacy of a mailed feedback and tips intervention as a universal prevention strategy for college drinking. Participants (N = 1,488) were randomly assigned to feedback or assessment-only control conditions. Results indicated that the mailed feedback intervention had a preventive effect on drinking rates overall, with participants in the feedback condition consuming less alcohol at follow-up in comparison with controls. In addition, abstainers in the feedback condition were twice as likely to remain abstinent from alcohol at follow-up in comparison with control participants (odds ratio = 2.02), and feedback participants were significantly more likely to refrain from heavy episodic drinking (odds ratio = 1.43). Neither gender nor severity of baseline drinking moderated the efficacy of the intervention in these analyses, but more conservative analyses utilizing last-observation carryforward suggested women and abstainers benefited more from this prevention approach. Protective behaviors mediated intervention efficacy, with participants who received the intervention being more likely to use strategies such as setting limits and alternating alcohol with nonalcoholic beverages. Implications of these findings for universal prevention of college drinking are discussed.

 


Brief motivational and parent interventions for college students: a randomized factorial study.

Mark Wood, Anne Fairlie, Anne Fernandez, Brian Borsari, Christy Capone, Robert Laforge, Rosa Carmona-Barros

Journal of consulting and clinical psychology [78:349-61] (2010)

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Using a randomized factorial design, we examined the efficacy of a brief motivational intervention (BMI) and a parent-based intervention (PBI) as universal preventive interventions to reduce alcohol use among incoming college students. Participants (N = 1,014) were assessed prior to matriculation and at 10 months and 22 months postbaseline. Two-part latent growth modeling was used to simultaneously examine initiation and growth in heavy episodic drinking and alcohol-related consequences. This study retained 90.8% (n = 921) of randomized students at the 10-month follow-up and 84.0% (n = 852) of randomized students at the 22-month follow-up. BMI participants were significantly less likely than non-BMI participants to initiate heavy episodic drinking and to begin experiencing alcohol-related consequences. Effect sizes were minimal at 10 months (Cohen's h ranged from 0.02 to 0.07) and were small at 22 months (hs ranged from 0.15 to 0.22). A significant BMI x PBI interaction revealed that students receiving both the BMI and the PBI were significantly less likely to report the onset of consequences beyond the sum of the individual intervention effects (h = 0.08 at 10 months, and h = 0.21 at 22 months). Hypothesized direct BMI effects for reductions in heavy episodic drinking and consequences were not observed. Significant mediated effects via changes in descriptive norms were present for both growth and initiation of heavy episodic drinking and consequences. To our knowledge, the current study is the first to provide support for BMI as a universal preventive intervention for incoming college students. Although hypothesized PBI main effects were not found, mediation analyses suggest future refinements could enhance PBI effectiveness.

 


Using a mobile health application to reduce alcohol consumption: a mixed-methods evaluation of the drinkaware track & calculate units application.

Sophie Attwood, Hannah Parke, John Larsen, Katie Morton

BMC public health [17:394] (2017)

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Smartphone applications ("apps") offer promise as tools to help people monitor and reduce their alcohol consumption. To date, few evaluations of alcohol reduction apps exist, with even fewer considering apps already available to the public. The aim of this study was to evaluate an existing publically available app, designed by Drinkaware, a UK-based alcohol awareness charity. We adopted a mixed-methods design, analysing routinely collected app usage data to explore user characteristics and patterns of usage. Following this, in-depth interviews were conducted with a sub-sample of app users to examine perceptions of acceptability, usability and perceived effectiveness, as well as to provide recommendations on how to improve the app. One hundred nineteen thousand seven hundred thirteen people downloaded and entered data into the app over a 13-month period. High attrition was observed after 1 week. Users who engaged with the app tended to be "high risk" drinkers and to report being motivated "to reduce drinking" at the point of first download. In those who consistently engaged with the app over time, self-reported alcohol consumption levels reduced, with most change occurring in the first week of usage. Our qualitative findings indicate satisfaction with the usability of the app, but mixed feedback was given regarding individual features. Users expressed conflicting views concerning the type of feedback and notifications that the app currently provides. A common preference was expressed for more personalised content. The Drinkaware app is a useful tool to support behaviour change in individuals who are already motivated and committed to reducing their alcohol consumption. The Drinkaware app would benefit from greater personalisation and tailoring to promote longer term use. This evaluation provides insight into the usability and acceptability of various app features and contains a number of recommendations for improving user satisfaction and the potential effectiveness of apps designed to encourage reductions in alcohol consumption.

 




Being controlled by normative influences: self-determination as a moderator of a normative feedback alcohol intervention.

Clayton Neighbors, Melissa Lewis, Rochelle Bergstrom, Mary Larimer

Health psychology : official journal of the Division of Health Psychology, American Psychological Association [25:571-9] (2006)

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The objectives of this research were to evaluate the efficacy of computer-delivered personalized normative feedback among heavy drinking college students and to evaluate controlled orientation as a moderator of intervention efficacy. Participants (N = 217) included primarily freshman and sophomore, heavy drinking students who were randomly assigned to receive or not to receive personalized normative feedback immediately following baseline assessment. Perceived norms, number of drinks per week, and alcohol-related problems were the main outcome measures. Controlled orientation was specified as a moderator. At 2-month follow-up, students who received normative feedback reported drinking fewer drinks per week than did students who did not receive feedback, and this reduction was mediated by changes in perceived norms. The intervention also reduced alcohol-related negative consequences among students who were higher in controlled orientation. These results provide further support for computer-delivered personalized normative feedback as an empirically supported brief intervention for heavy drinking college students, and they enhance the understanding of why and for whom normative feedback is effective.

 



Efficacy of web-based personalized normative feedback: a two-year randomized controlled trial

Clayton Neighbors, Melissa Lewis, David Atkins, Megan Jensen, Theresa Walter, Nicole Fossos, Christine Lee, Mary Larimer

Journal of consulting and clinical psychology [78:898-911] (2010)

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Web-based brief alcohol interventions have the potential to reach a large number of individuals at low cost; however, few controlled evaluations have been conducted to date. The present study was designed to evaluate the efficacy of gender-specific versus gender-nonspecific personalized normative feedback (PNF) with single versus biannual administration in a 2-year randomized controlled trial targeting a large sample of heavy-drinking college students. Participants included 818 freshmen (57.6% women; 42% non-Caucasian) who reported 1 or more heavy-drinking episodes in the previous month at baseline. Participants were randomly assigned in a 2 (gender-specific vs. gender-nonspecific PNF) × 2 (single vs. biannual administration of PNF) + 1 (attention control) design. Assessments occurred every 6 months for a 2-year period. Results from hierarchical generalized linear models provided modest effects on weekly drinking and alcohol-related problems but not on heavy episodic drinking. Relative to control, gender-specific biannual PNF was associated with reductions over time in weekly drinking (d = -0.16, 95% CI [-0.02, -0.31]), and this effect was partially mediated by changes in perceived norms. For women, but not men, gender-specific biannual PNF was associated with reductions over time in alcohol-related problems relative to control (d = -0.29, 95% CI [-0.15, -0.58]). Few other effects were evident. The present research provides modest support for the use of biannually administered web-based gender-specific PNF as an alternative to more costly indicated prevention strategies.

 




The effect of brief interventions on alcohol consumption among heavy drinkers in a general hospital setting.

Aisha Holloway, Hazel Watson, Antony Arthur, George Starr, Angus McFadyen, Jean McIntosh

Addiction (Abingdon, England) [102:1762-70] (2007)

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(i) To evaluate the effect of receiving one of two brief interventions in reducing alcohol consumption among general hospital patients compared with usual care. (ii) To assess whether a brief intervention of self-efficacy enhancement was superior to a self-help booklet in reducing alcohol consumption. A three-arm cluster randomized controlled trial. Seven general medical, six general surgical, one dermatology and two otolaryngology wards of a large teaching hospital covering a large urban and rural area. A total of 215 of 789 in-patients aged 18-75 years, who screened positive for alcohol consumption in excess of national recommended limits according to a 7-day retrospective drinking diary. Participants were allocated to receive one of three interventions: (i) face-to-face self-efficacy enhancement; (ii) a self-help booklet; or (iii) usual care. The primary outcome measure was change in reported alcohol consumption at 6-month follow-up as measured by a 7-day retrospective drinking diary. Secondary outcomes were change in: number of alcohol drinking days in last week; the maximum units of alcohol consumed on any one day in last week; and Drinking Refusal Self-efficacy Expectancy Questionnaire score. Compared to the usual care group the self-efficacy enhancement group (-10.1 units 95% CI -16.1 to -4.1) and the self-help booklet group (-10.0 units 95% CI -16.0 to -3.9) had greater reductions in self-reported weekly alcohol consumption. There was no evidence that self-efficacy enhancement was superior to the self-help booklet (P = 0.96). Brief interventions delivered in hospital offer simple means of helping heavy drinkers to reduce their alcohol consumption.

 



RCT of web-based personalized normative feedback for college drinking prevention: are typical student norms good enough?

Joseph Labrie, Melissa Lewis, David Atkins, Clayton Neighbors, Cheng Zheng, Shannon Kenney, Lucy Napper, Theresa Walter, Jason Kilmer, Justin Hummer, Joel Grossbard, Tehniat Ghaidarov, Sruti Desai, Christine Lee, Mary Larimer

Journal of consulting and clinical psychology [81:1074-86] (2013)

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Personalized normative feedback (PNF) interventions are generally effective at correcting normative misperceptions and reducing risky alcohol consumption among college students. However, research has yet to establish what level of reference group specificity is most efficacious in delivering PNF. This study compared the efficacy of a web-based PNF intervention using 8 increasingly specific reference groups against a Web-BASICS intervention and a repeated-assessment control in reducing risky drinking and associated consequences. Participants were 1,663 heavy-drinking Caucasian and Asian undergraduates at 2 universities. The referent for web-based PNF was either the typical same-campus student or a same-campus student at 1 (either gender, race, or Greek affiliation), or a combination of 2 (e.g., gender and race), or all 3 levels of specificity (i.e., gender, race, and Greek affiliation). Hypotheses were tested using quasi-Poisson generalized linear models fit by generalized estimating equations. The PNF intervention participants showed modest reductions in all 4 outcomes (average total drinks, peak drinking, drinking days, and drinking consequences) compared with control participants. No significant differences in drinking outcomes were found between the PNF group as a whole and the Web-BASICS group. Among the 8 PNF conditions, participants receiving typical student PNF demonstrated greater reductions in all 4 outcomes compared with those receiving PNF for more specific reference groups. Perceived drinking norms and discrepancies between individual behavior and actual norms mediated the efficacy of the intervention. Findings suggest a web-based PNF intervention using the typical student referent offers a parsimonious approach to reducing problematic alcohol use outcomes among college students.

 





A mobile phone intervention to reduce binge drinking among disadvantaged men: study protocol for a randomised controlled cost-effectiveness trial.

Iain Crombie, Linda Irvine, Brian Williams, Falko Sniehotta, Dennis Petrie, Josie Evans, Carol Emslie, Claire Jones, Ian Ricketts, Gerry Humphris, John Norrie, Peter Rice, Peter Slane

Trials [15:494] (2014)

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Socially disadvantaged men are at a substantially higher risk of developing alcohol-related problems. The frequency of heavy drinking in a single session is high among disadvantaged men. Brief alcohol interventions were developed for, and are usually delivered in, healthcare settings. The group who binge drink most frequently, young to middle-aged disadvantaged men, have less contact with health services and there is a need for an alternative method of intervention delivery. Text messaging has been used successfully to modify other adverse health behaviours. This study will test whether text messages can reduce the frequency of binge drinking by disadvantaged men. Disadvantaged men aged 25 to 44 years who drank >8 units of alcohol at least twice in the preceding month will be recruited from the community. Two recruitment strategies will be used: contacting men listed in primary care registers, and a community outreach method (time-space sampling). The intended sample of 798 men will be randomised to intervention or control, stratifying by recruitment method. The intervention group will receive a series of text messages designed to reduce the frequency of binge drinking through the formation of specific action plans. The control group will receive behaviourally neutral text messages intended to promote retention in the study. The primary outcome measure is the proportion of men consuming >8 units on at least three occasions in the previous 30 days. Secondary outcomes include total alcohol consumption and the frequency of consuming more than 16 units of alcohol in one session in the previous month. Process measures, developed during a previous feasibility study, will monitor engagement with the key behaviour change components of the intervention. The study will incorporate an economic evaluation comparing the costs of recruitment and intervention delivery with the benefits of reduced alcohol-related harm. This study will assess the effectiveness of a brief intervention, delivered by text messages, aimed at reducing the frequency of binge drinking in disadvantaged men. The process measures will identify components of the intervention which contribute to effectiveness. The study will also determine whether any benefit of the intervention is justified by the costs of intervening. ISRCTN07695192. Date assigned: 14 August 2013.

 


An intervention to reduce alcohol consumption in undergraduate students using implementation intentions and mental simulations: a cross-national study.

Martin Hagger, Adam Lonsdale, Andre Koka, Vello Hein, Heidi Pasi, Taru Lintunen, Nikos Chatzisarantis

International journal of behavioral medicine [19:82-96] (2012)

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Excessive alcohol consumption has been linked to deleterious health consequences among undergraduate students. There is a need to develop theory-based and cost-effective brief interventions to attenuate alcohol consumption in this population. The present study tested the effectiveness of an integrated theory-based intervention in reducing undergraduates' alcohol consumption in excess of guideline limits in national samples from Estonia, Finland, and the UK. A 2 (volitional: implementation intention vs. no implementation intention) × 2 (motivation: mental simulation vs. no mental simulation) × 3 (nationality: Estonia vs. Finland vs. UK) randomized-controlled design was adopted. Participants completed baseline psychological measures and self-reported number of alcohol units consumed and binge-drinking frequency followed by the intervention manipulation. One month later, participants completed follow-up measures of the psychological variables and alcohol consumption. Results revealed main effects for implementation intention and nationality on units of alcohol consumed at follow-up and an implementation intention × nationality interaction. Alcohol consumption was significantly reduced in the implementation intention condition for the Estonian and UK samples. There was a significant main effect for nationality and an implementation intention × nationality interaction on binge-drinking frequency. Follow-up tests revealed significant reductions in binge-drinking occasions in the implementation intention group for the UK sample only. Results support the implementation intention component of the intervention in reducing alcohol drinking in excess of guideline limits among Estonian and UK undergraduates. There was no support for the motivational intervention or the interaction between the strategies. Results are discussed with respect to intervention design based on motivational and volitional approaches.

 



Decreasing hospital-associated rotavirus infection: a multidisciplinary hand hygiene campaign in a children's hospital.

Danielle Zerr, Amanda Allpress, Joan Heath, Rena Bornemann, Elizabeth Bennett

The Pediatric infectious disease journal [24:397-403] (2005)

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Hand hygiene is an effective means of preventing hospital-associated infection, but compliance among health care workers is poor. Few studies aimed at increasing hand hygiene in the hospital setting have shown sustained improvement and concurrent decreases in hospital-associated infections, and even fewer have been performed in the pediatric setting. We implemented a hand hygiene program with the hopes of improving hand hygiene and decreasing hospital-associated rotavirus infection rates. A multidisciplinary group developed a hospital supported, house-wide campaign. Opportunities for hand hygiene were observed during 5 periods. The frequency of hospital-associated rotavirus infection was tracked over time by review of laboratory records. Correlates of hand hygiene were investigated with the use of multivariate logistic regression. Overall hand hygiene compliance improved from 62% in period 1 to 81% in period 5 (P < 0.001). Soap and water was the most common method for practicing hand hygiene, and alcohol hand gel use increased from 4% to 29% between the first and last observation periods (P < 0.001). The rate of hospital-associated rotavirus infection decreased from 5.9 episodes per 1000 discharged patients in 2001 to 2.2 episodes per 1000 discharged patients in 2004 (P = 0.01). Period of observation, hospital ward, type of care provider and type of care performed were all independently associated with hand hygiene (adjusted P < or = 0.02 for all). Improving hand hygiene is an important goal for health care institutions. These data can be useful for development of interventions aimed at improving hand hygiene.

 




Evaluating brief motivational and self-regulatory hand hygiene interventions: a cross-over longitudinal design.

Pempa Lhakhang, Sonia Lippke, Nina Knoll, Ralf Schwarzer

BMC public health [15:79] (2015)

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Frequent handwashing can prevent infections, but non-compliance to hand hygiene is pervasive. Few theory- and evidence-based interventions to improve regular handwashing are available. Therefore, two intervention modules, a motivational and a self-regulatory one, were designed and evaluated. In a longitudinal study, 205 young adults, aged 18 to 26 years, were randomized into two intervention groups. The Mot-SelfR group received first a motivational intervention (Mot; risk perception and outcome expectancies) followed by a self-regulatory intervention (SelfR; perceived self-efficacy and planning) 17 days later. The SelfR-Mot group received the same two intervention modules in the opposite order. Follow-up data were assessed 17 and 34 days after the baseline. Both intervention sequences led to an increase in handwashing frequency, intention, self-efficacy, and planning. Also, overall gains were found for the self-regulatory module (increased planning and self-efficacy levels) and the motivational module (intention). Within groups, the self-regulatory module appeared to be more effective than the motivational module, independent of sequence. Self-regulatory interventions can help individuals to exhibit more handwashing. Sequencing may be important as a motivation module (Mot) first helps to set the goal and a self-regulatory module (SelfR) then helps to translate this goal into actual behavior, but further research is needed to evaluate mechanisms.

 


Promoting Hand Hygiene Compliance.

Thomas von Lengerke, Bettina Lutze, Christian Krauth, Karin Lange, Jona Stahmeyer, Iris Chaberny

Deutsches Arzteblatt international [114:29-36] (2017)

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The German "Clean Hands Campaign" (an adaptation of the WHO "Clean Care is Safer Care" programme) to promote hand hygiene among hospital personnel at Hannover Medical School (MHH, Medizinische Hochschule Hannover), known as Aktion Saubere Hände (ASH), met with initial success. By 2013, however, compliance rates with hygienic hand disinfection in the hospital's ten intensive care units (ICUs) and two hematopoietic stem cell transplantation units (HSCTUs) had relapsed to their initial levels (physicians: 48%; nurses: 56%). The cluster- randomized controlled trial PSYGIENE was conducted to investigate whether interventions tai - lored in ways suggested by research in behavioral psychology might bring about more sustainable improvements than the ASH. The "Health Action Process Approach" (HAPA) compliance model specifies key psychological determinants of compliance. These determinants were assessed among health care workers in the ICUs and HSCTUs of the MHH by questionnaire (response rates: physicians: 71%; nurses: 63%) and by interviews of the responsible ward physicians and head nurses (100%). In 2013, 29 tailored behavior change techniques were implemented in educational training sessions and feedback discussions in the six wards that constituted the intervention arm of the trial, while ASH training sessions were provided in the control arm. The compliance rates for 2014 and 2015 (the primary outcomes of the trial) were determined by nonparticipating observation of hygienic hand disinfection, in accordance with the World Health Organization's gold standard. The two groups did not differ in their baseline compliance rates in 2013 (intervention: 54%, control: 55%, p = 0.581). The tailored interventions led to increased compliance in each of the two follow-up years (2014: 64%, p<0.001; 2015: 70%, p = 0.001), while the compliance in the control arm increased to 68% in 2014 (p<0.001) but fell back to 64% in 2015 (p = 0.007). The compliance increases from 2013-2015 and the compliance rate in 2015 were higher in the intervention arm (p<0.005). This was mainly attributable to the nurses' behavior, as the corresponding parameters for physicians did not differ significantly between the two study arms in stratified analysis. Tailored interventions based on behavioral psychology principles led to more sustainable increases in compliance with hand hygiene guidelines than ASH training sessions did. This was true among nurses, and thus also for hospital ward personnel as a whole (i.e., nurses and physicians combined). Further studies are needed to identify more target group-specific interventions that may improve compliance among physicians.

 


A brief report on the development of a theoretically-grounded intervention to promote patient autonomy and self-management of physiotherapy patients: face validity and feasibility of implementation.

James Matthews, Amanda Hall, Marian Hernon, Aileen Murray, Ben Jackson, Ian Taylor, John Toner, Suzanne Guerin, Chris Lonsdale, Deirdre Hurley

BMC health services research [15:260] (2015)

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Clinical practice guidelines for the treatment of low back pain suggest the inclusion of a biopsychosocial approach in which patient self-management is prioritized. While many physiotherapists recognise the importance of evidence-based practice, there is an evidence practice gap that may in part be due to the fact that promoting self-management necessitates change in clinical behaviours. Evidence suggests that a patient's motivation and maintenance of self-management behaviours can be positively influenced by the clinician's use of an autonomy supportive communication style. Therefore, the aim of this study was to develop and pilot-test the feasibility of a theoretically derived implementation intervention to support physiotherapists in using an evidence-based autonomy supportive communication style in practice for promoting patient self-management in clinical practice. A systematic process was used to develop the intervention and pilot-test its feasibility in primary care physiotherapy. The development steps included focus groups to identify barriers and enablers for implementation, the theoretical domains framework to classify determinants of change, a behaviour change technique taxonomy to select appropriate intervention components, and forming a testable theoretical model. Face validity and acceptability of the intervention was pilot-tested with two physiotherapists and monitoring their communication with patients over a three-month timeframe. Using the process described above, eight barriers and enablers for implementation were identified. To address these barriers and enablers, a number of intervention components were selected ranging from behaviour change techniques such as, goal-setting, self-monitoring and feedback to appropriate modes of intervention delivery (i.e. continued education meetings and audit and feedback focused coaching). Initial pilot-testing revealed the acceptability of the intervention to recipients and highlighted key areas for refinement prior to scaling up for a definitive trial. The development process utilised in this study ensured the intervention was theory-informed and evidence-based, with recipients signalling its relevance and benefit to their clinical practice. Future research should consider additional intervention strategies to address barriers of social support and those beyond the clinician level.

 


Mobile Technology Interventions for Asthma Self-Management: Systematic Review and Meta-Analysis.

Lisa Miller, Benjamin Schüz, Julia Walters, E Haydn Walters

JMIR mHealth and uHealth [5:e57] (2017)

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Mobile technology interventions (MTI) are becoming increasingly popular in the management of chronic health behaviors. Most MTI allow individuals to monitor medication use, record symptoms, or store and activate disease-management action plans. Therefore, MTI may have the potential to improve low adherence to medication and action plans for individuals with asthma, which is associated with poor clinical outcomes. A systematic review and meta-analysis were conducted to evaluate the efficacy of MTI on clinical outcomes as well as adherence in individuals with asthma. As the use of evidence-based behavior change techniques (BCT) has been shown to improve intervention effects, we also conducted exploratory analyses to determine the role of BCT and engagement with MTI as moderators of MTI efficacy. We searched electronic databases for randomized controlled trials up until June 2016. Random effect models were used to assess the effect of MTI on clinical outcomes as well as adherence to preventer medication or symptom monitoring. Mixed effects models assessed whether the features of the MTI (ie, use of BCT) and how often a person engaged with MTI moderated the effects of MTI. The literature search located 11 studies meeting the inclusion criteria, with 9 providing satisfactory data for meta-analysis. Compared with standard treatment, MTI had moderate to large effect sizes (Hedges g) on medication adherence and clinical outcomes. MTI had no additional effects on adherence or clinical outcomes when compared with paper-based monitoring. No moderator effects were found, and the number of studies was small. A narrative review of the two studies, which are not included in the meta-analysis, found similar results. This review indicated the efficacy of MTI for self-management in individuals with asthma and also indicated that MTI appears to be as efficacious as paper-based monitoring. This review also suggested a need for robust studies to examine the effects of BCT use and engagement on MTI efficacy to inform the evidence base for MTI in individuals with asthma.

 


Managing fatigue after cancer treatment: development of RESTORE, a web-based resource to support self-management.

C Foster, L Calman, C Grimmett, M Breckons, P Cotterell, L Yardley, J Joseph, S Hughes, R Jones, C Leonidou, J Armes, L Batehup, J Corner, D Fenlon, E Lennan, C Morris, A Neylon, E Ream, L Turner, A Richardson

Psycho-oncology [24:940-9] (2015)

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The aim of this study is to co-create an evidence-based and theoretically informed web-based intervention (RESTORE) designed to enhance self-efficacy to live with cancer-related fatigue (CRF) following primary cancer treatment. A nine-step process informed the development of the intervention: (1) review of empirical literature; (2) review of existing patient resources; (3) establish theoretical framework; (4) establish design team with expertise in web-based interventions, CRF and people affected by cancer; (5) develop prototype intervention; (6) user testing phase 1; (7) refinement of prototype; (8) user testing phase 2; and (9) develop final intervention. Key stakeholders made a critical contribution at every step of intervention development, and user testing, which involved an iterative process and resulted in the final intervention. The RESTORE intervention has five sessions; sessions 1 and 2 include an introduction to CRF and goal setting. Sessions 3-5 can be tailored to user preference and are designed to cover areas of life where CRF may have an impact: home and work life, personal relationships and emotional adjustment. It is feasible to systematically 'co-create' an evidence-based and theory-driven web-based self-management intervention to support cancer survivors living with the consequences of cancer and its treatment. This is the first account of the development of a web-based intervention to support self-efficacy to manage CRF. An exploratory trial to test the feasibility and acceptability of RESTORE is now warranted.

 


Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS).

Deirdre Hurley, Laura Currie Murphy, David Hayes, Amanda Hall, Elaine Toomey, Suzanne McDonough, Chris Lonsdale, Nicola Walsh, Suzanne Guerin, James Matthews

Implementation science : IS [11:56] (2016)

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The Medical Research Council framework provides a useful general approach to designing and evaluating complex interventions, but does not provide detailed guidance on how to do this and there is little evidence of how this framework is applied in practice. This study describes the use of intervention mapping (IM) in the design of a theory-driven, group-based complex intervention to support self-management (SM) of patients with osteoarthritis (OA) and chronic low back pain (CLBP) in Ireland's primary care health system. The six steps of the IM protocol were systematically applied to develop the self-management of osteoarthritis and low back pain through activity and skills (SOLAS) intervention through adaptation of the Facilitating Activity and Self-management in Arthritis (FASA) intervention. A needs assessment including literature reviews, interviews with patients and physiotherapists and resource evaluation was completed to identify the programme goals, determinants of SM behaviour, consolidated definition of SM and required adaptations to FASA to meet health service and patient needs and the evidence. The resultant SOLAS intervention behavioural outcomes, performance and change objectives were specified and practical application methods selected, followed by organised programme, adoption, implementation and evaluation plans underpinned by behaviour change theory. The SOLAS intervention consists of six weekly sessions of 90-min education and exercise designed to increase participants' physical activity level and use of evidence-based SM strategies (i.e. pain self-management, pain coping, healthy eating for weight management and specific exercise) through targeting of individual determinants of SM behaviour (knowledge, skills, self-efficacy, fear, catastrophizing, motivation, behavioural regulation), delivered by a trained physiotherapist to groups of up to eight individuals using a needs supportive interpersonal style based on self-determination theory. Strategies to support SOLAS intervention adoption and implementation included a consensus building workshop with physiotherapy stakeholders, development of a physiotherapist training programme and a pilot trial with physiotherapist and patient feedback. The SOLAS intervention is currently being evaluated in a cluster randomised controlled feasibility trial. IM is a time-intensive collaborative process, but the range of methods and resultant high level of transparency is invaluable and allows replication by future complex intervention and trial developers.

 


Self-Monitoring Utilization Patterns Among Individuals in an Incentivized Program for Healthy Behaviors.

Ju Young Kim, Nathan Wineinger, Michael Taitel, Jennifer Radin, Osayi Akinbosoye, Jenny Jiang, Nima Nikzad, Gregory Orr, Eric Topol, Steve Steinhubl

Journal of medical Internet research [18:e292] (2016)

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The advent of digital technology has enabled individuals to track meaningful biometric data about themselves. This novel capability has spurred nontraditional health care organizations to develop systems that aid users in managing their health. One of the most prolific systems is Walgreens Balance Rewards for healthy choices (BRhc) program, an incentivized, Web-based self-monitoring program. This study was performed to evaluate health data self-tracking characteristics of individuals enrolled in the Walgreens' BRhc program, including the impact of manual versus automatic data entries through a supported device or apps. We obtained activity tracking data from a total of 455,341 BRhc users during 2014. Upon identifying users with sufficient follow-up data, we explored temporal trends in user participation. Thirty-four percent of users quit participating after a single entry of an activity. Among users who tracked at least two activities on different dates, the median length of participating was 8 weeks, with an average of 5.8 activities entered per week. Furthermore, users who participated for at least twenty weeks (28.3% of users; 33,078/116,621) consistently entered 8 to 9 activities per week. The majority of users (77%; 243,774/315,744) recorded activities through manual data entry alone. However, individuals who entered activities automatically through supported devices or apps participated roughly four times longer than their manual activity-entering counterparts (average 20 and 5 weeks, respectively; P<.001). This study provides insights into the utilization patterns of individuals participating in an incentivized, Web-based self-monitoring program. Our results suggest automated health tracking could significantly improve long-term health engagement.

 


Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial.

K Lorig, D Sobel, A Stewart, B Brown, A Bandura, P Ritter, V Gonzalez, D Laurent, H Holman

Medical care [37:5-14] (1999)

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This study evaluated the effectiveness (changes in health behaviors, health status, and health service utilization) of a self-management program for chronic disease designed for use with a heterogeneous group of chronic disease patients. It also explored the differential effectiveness of the intervention for subjects with specific diseases and comorbidities. The study was a six-month randomized, controlled trial at community-based sites comparing treatment subjects with wait-list control subjects. Participants were 952 patients 40 years of age or older with a physician-confirmed diagnosis of heart disease, lung disease, stroke, or arthritis. Health behaviors, health status, and health service utilization, as determined by mailed, self-administered questionnaires, were measured. Treatment subjects, when compared with control subjects, demonstrated improvements at 6 months in weekly minutes of exercise, frequency of cognitive symptom management, communication with physicians, self-reported health, health distress, fatigue, disability, and social/role activities limitations. They also had fewer hospitalizations and days in the hospital. No differences were found in pain/physical discomfort, shortness of breath, or psychological well-being. An intervention designed specifically to meet the needs of a heterogeneous group of chronic disease patients, including those with comorbid conditions, was feasible and beneficial beyond usual care in terms of improved health behaviors and health status. It also resulted in fewer hospitalizations and days of hospitalization.

 



A user-centred approach to developing bWell, a mobile app for arm and shoulder exercises after breast cancer treatment.

Helena Harder, Patrick Holroyd, Lynn Burkinshaw, Phil Watten, Charles Zammit, Peter Harris, Anna Good, Val Jenkins

Journal of cancer survivorship : research and practice (2017)

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The study aim was to develop a mobile application (app) supported by user preferences to optimise self-management of arm and shoulder exercises for upper-limb dysfunction (ULD) after breast cancer treatment. Focus groups with breast cancer patients were held to identify user needs and requirements. Behaviour change techniques were explored by researchers and discussed during the focus groups. Concepts for content were identified by thematic analysis. A rapid review was conducted to inform the exercise programme. Preliminary testing was carried out to obtain user feedback from breast cancer patients who used the app for 8 weeks post surgery. Breast cancer patients' experiences with ULD and exercise advice and routines varied widely. They identified and prioritised several app features: tailored information, video demonstrations of the exercises, push notifications, and tracking and progress features. An evidence-based programme was developed with a physiotherapist with progressive exercises for passive and active mobilisation, stretching and strengthening. The exercise demonstration videos were filmed with a breast cancer patient. Early user testing demonstrated ease of use, and clear and motivating app content. bWell, a novel app for arm and shoulder exercises, was developed by breast cancer patients, health care professionals and academics. Further research is warranted to confirm its clinical effectiveness. Mobile health has great potential to provide patients with information specific to their needs. bWell is a promising way to support breast cancer patients with exercise routines after treatment and may improve future self-management of clinical care.

 


Details of development of the resource for adults with asthma in the RAISIN (randomized trial of an asthma internet self-management intervention) study.

Deborah Morrison, Frances Mair, Rekha Chaudhuri, Marilyn McGee-Lennon, Mike Thomas, Neil Thomson, Lucy Yardley, Sally Wyke

BMC medical informatics and decision making [15:57] (2015)

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Around 300 million people worldwide have asthma and prevalence is increasing. Self-management can be effective in improving a range of outcomes and is cost effective, but is underutilised as a treatment strategy. Supporting optimum self-management using digital technology shows promise, but how best to do this is not clear. We aimed to develop an evidence based, theory informed, online resource to support self-management in adults with asthma, called 'Living well with Asthma', as part of the RAISIN (Randomized Trial of an Asthma Internet Self-Management Intervention) study. We developed Living well with Asthma in two phases. Phase 1: A low fidelity prototype (paper-based) version of the website was developed iteratively through input from a multidisciplinary expert panel, empirical evidence from the literature, and potential end users via focus groups (adults with asthma and practice nurses). Implementation and behaviour change theories informed this process. Phase 2: The paper-based designs were converted to a website through an iterative user centred process. Adults with asthma (n = 10) took part in think aloud studies, discussing the paper based version, then the web-based version. Participants considered contents, layout, and navigation. Development was agile using feedback from the think aloud sessions immediately to inform design and subsequent think aloud sessions. Think aloud transcripts were also thematically analysed, further informing resource development. The website asked users to aim to be symptom free. Key behaviours targeted to achieve this include: optimising medication use (including inhaler technique); attending primary care asthma reviews; using asthma action plans; increasing physical activity levels; and stopping smoking. The website had 11 sections, plus email reminders, which promoted these behaviours. Feedback on the contents of the resource was mainly positive with most changes focussing on clarification of language, order of pages and usability issues mainly relating to navigation difficulties. Our multifaceted approach to online intervention development underpinned by theory, using evidence from the literature, co-designed with end users and a multidisciplinary panel has resulted in a resource which end users find relevant to their needs and easy to use. Living well with Asthma is undergoing evaluation within a randomized controlled trial.

 


'Help for Hay Fever', a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial.

Terry Porteous, Sally Wyke, Sarah Smith, Christine Bond, Jill Francis, Amanda Lee, Richard Lowrie, Graham Scotland, Aziz Sheikh, Mike Thomas, Lorraine Smith

Trials [14:217] (2013)

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Despite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based 'goal-focused' intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT). A pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome measures relate to changes in symptom severity, productivity, medication adherence and self-efficacy. Quantitative data about accrual, retention and economic measures, and qualitative data about participants' experiences during the trial will be collected to inform the future RCT. This work will lay the foundations for a definitive RCT of a community pharmacy-based 'goal-focused' self-management intervention for people with intermittent allergic rhinitis. Results of the pilot trial are expected to be available in April 2013. Current Controlled Trials ISRCTN43606442.

 


The effectiveness of an enhanced invitation letter on uptake of National Health Service Health Checks in primary care: a pragmatic quasi-randomised controlled trial.

Anna Sallis, Amanda Bunten, Annabelle Bonus, Andrew James, Tim Chadborn, Daniel Berry

BMC family practice [17:35] (2016)

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The National Health Service Health Check (NHS HC) is a population level public health programme. It is a primary prevention initiative offering cardiovascular risk assessment and management for adults aged 40-74 years (every five years). It was designed to reduce the incidence of major vascular disease events by preventing or delaying the onset of diabetes, heart and kidney disease, stroke and vascular dementia . Effectiveness of the programme has been modelled on a national uptake of 75% however in 2012/13 uptake, nationally, was 49%. Ensuring a high percentage of those offered an NHS HC actually receive one is key to optimising the clinical and cost effectiveness of the programme. A pragmatic quasi-randomised controlled trial was conducted in four general practitioner practices in Medway, England with randomisation of 3511 patients. The aim was to compare attendance at the NHS HC using the standard national invitation template letter (control) compared to an enhanced invitation letter using insights from behavioural science (intervention). The intervention letter includes i) simplification - reducing letter content for less effortful processing ii) behavioural instruction - action focused language iii) personal salience - appointment due rather than invited and iv) addressing implementation intentions with a tear off slip to record the date, time and location of the appointment. Logistic Regression explored the association between control and intervention group and attendance at a health check. 29.3% of patients who received the control letter and 33.5% of those who received the intervention letter attended their NHS HC (adjusted odds ratio 1.26, 95% confidence interval 1.09-1.47, p < 0.01). This was an absolute difference in uptake of 4.2 percentage points for those receiving the intervention letter. An invitation letter applying behavioural insights was more effective than the existing national template letter at encouraging attendance at an NHS HC. Making small, no cost behaviourally informed changes to letter invitations can improve uptake of the NHS HC. Further research is required to replicate the effect with more robust methodology and powered for sub-group analysis including socio-economic status. Current Controlled Trials ISRCTN66757664 , date of registration 28/3/2014.

 


Testing the Implementation of a Pain Self-management Support Intervention for Oncology Patients in Clinical Practice: A Randomized Controlled Pilot Study (ANtiPain).

Antje Koller, Jan Gaertner, Sabina De Geest, Monika Hasemann, Gerhild Becker

Cancer nursing (2017)

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In oncology, pain control is a persistent problem. Significant barriers to cancer pain management are patient related. Pain self-management support interventions have shown to reduce pain intensity and patient-related barriers. Comparative effectiveness research is a suitable approach to test whether effects are sustained in clinical practice. In this pilot randomized controlled trial, the implementation of the ANtiPain intervention into clinical practice was tested to assess the effects on pain intensity, function-related outcomes, self-efficacy, and patient-related barriers to pain management to prepare a larger effectiveness trial. Within 14 months, 39 adult oncology patients with pain scores of 3 or higher on a 10-point numeric rating scale were recruited in an academic comprehensive cancer center in Southern Germany. Patients in the control group (n=19) received standard care. Patients in the intervention group (n=20) received ANtiPain, a cancer pain self-management support intervention based on 3 key strategies: provision of information, skill building, and nurse coaching. An intervention session was performed in-hospital. After discharge, follow-up was provided via telephone calls. Data were collected at baseline and 1 and 6 weeks after discharge. Effect sizes were calculated for all outcomes. Large effects were found for activity hindrance (Cohen d=0.90), barriers (d=0.91), and self-efficacy (d=0.90). Small to moderate effects were found for average and worst pain (Cohen d=0.17-0.45). Key findings of this study involved function-related outcomes and self-efficacy. Because these outcomes are particularly meaningful for patients, the integration of ANtiPain to routine clinical practice may be substantial. A larger study will be based on these findings.

 


Self-management in temporomandibular disorders: a systematic review of behavioural components.

W Story, J Durham, M Al-Baghdadi, J Steele, V Araujo-Soares

Journal of oral rehabilitation [43:759-70] (2016)

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The aim of this qualitative systematic review was to identify the behaviour change techniques most frequently employed in published temporomandibular disorder (TMD) self-management (SM) programmes. The reviewers matched the components of SM programmes into the relevant behaviour change technique domains according to the definitions of the behaviour change taxonomy (version 1). Electronic databases were searched for randomised controlled trials assessing an SM programme for TMD. Manual searches were also conducted for potentially important journals. Eligibility criteria for the review included: the type of study, the participants, the intervention utilised and the comparators/control. Fifteen randomised controlled trials with 554 patients were included in this review. The review concludes a minority of the available behaviour change techniques are currently employed in SM programmes. Other behaviour change techniques should be examined to see whether there is a theoretical underpinning that might support their inclusion in self-management programmes in TMD. Further trials are required to conclude that SM programmes are more effective than no treatment at all and or placebo. With more structured SM programmes, greater therapeutic benefits might be achieved, and certainly if SM programmes published in the literature define their components through use of the behaviour change taxonomy, it would be easier for clinicians to replicate efficacious programmes.

 



Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol.

Leila Pfaeffli Dale, Robyn Whittaker, Yannan Jiang, Ralph Stewart, Anna Rolleston, Ralph Maddison

Trials [15:71] (2014)

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Cardiac rehabilitation (CR) is a secondary prevention program that offers education and support to assist patients with coronary heart disease (CHD) make lifestyle changes. Despite the benefits of CR, attendance at centre-based sessions remains low. Mobile technology (mHealth) has potential to reach more patients by delivering CR directly to mobile phones, thus providing an alternative to centre-based CR. The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours (for example, physically active, fruit and vegetable intake, not smoking, low alcohol consumption) over and above usual CR services in New Zealand adults diagnosed with CHD. A two-arm, parallel, randomised controlled trial will be conducted at two Auckland hospitals in New Zealand. One hundred twenty participants will be randomised to receive a 24-week evidence- and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone (control). The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months, measured using a composite health behaviour score. Secondary outcomes include overall cardiovascular disease risk, body composition, illness perceptions, self-efficacy, hospital anxiety/depression and medication adherence. This study is one of the first to examine an mHealth-delivered comprehensive CR program. Strengths of the trial include quality research design and in-depth description of the intervention to aid replication. If effective, the trial has potential to augment standard CR practices and to be used as a model for other disease prevention or self-management programs. Australian New Zealand Clinical Trials Registry: ACTRN12613000901707.

 


Self-management support in routine primary care by nurses.

Heleen Westland, Carin Schröder, Jessica de Wit, Judith Frings, Jaap Trappenburg, Marieke Schuurmans

British journal of health psychology (2017)

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To examine how and to what extent self-management support, including behaviour change support, is provided by primary care nurses in routine consultations with chronically ill patients. Observational study design. Routine consultations of primary care nurses in the Netherlands with chronically ill patients were audio-taped and analysed. The analysis identified health topics addressed according to health care standards, self-management topics addressed using a validated set of topics, and behaviour change techniques (BCTs) using the Behaviour Change Techniques Taxonomy v1. Seventy-eight routine consultations of 17 primary care nurses with chronically ill patients were included in the analysis. Nurses addressed both health topics and self-management topics in brief, fragmented, and often inconsistent manners. Dietary intake and physical activity were the most frequently addressed topics. Nurses applied 21 BCTs to target behaviour change, but the use of these techniques was mainly inconsistent and implicit. The most consistently used BCTs were review behaviour goal(s) (56.4%) and feedback on behaviour (51.3%). Nurses addressed both health topics and self-management topics in their routine consultations. The duration, frequency, and number of addressed topics differed throughout the consultations. Nurses tended to prioritize the monitoring and optimization of patients' medical treatment and provided limited self-management support. Nurses seldom deepened their focus on behaviour change and infrequently used effective techniques to support this change. Adoption of self-management in primary care, including behaviour change, might be enhanced if nurses consistently and explicitly use effective BCTs in their consultations. Statement of contribution What is already known on this subject? Primary care nurses play a pivotal role in self-management support for patients with a chronic condition. Adequate self-management support requires nurses to activate patients and enhance behaviour change. Little is known regarding to what extent nurses provide self-management support in routine primary care. What does this study add? Self-management support is brief, fragmented, and inconsistently provided by nurses. Nurses tend to prioritize medical treatment optimization and seldom focus on behavioural change. Nurses' use of effective behaviour change techniques is low and should be enhanced.

 


Development and Validation of an Interactive Internet Platform for Older People: The Healthy Ageing Through Internet Counselling in the Elderly Study.

Susan Jongstra, Cathrien Beishuizen, Sandrine Andrieu, Mariagnese Barbera, Matthijs van Dorp, Bram van de Groep, Juliette Guillemont, Francesca Mangialasche, Tessa van Middelaar, Eric Moll van Charante, Hilkka Soininen, Miia Kivipelto, Edo Richard

Telemedicine journal and e-health : the official journal of the American Telemedicine Association (2016)

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A myriad of Web-based applications on self-management have been developed, but few focus on older people. In the face of global aging, older people form an important target population for cardiovascular prevention. This article describes the full development of an interactive Internet platform for older people, which was designed for the Healthy Ageing Through Internet Counselling in the Elderly (HATICE) study. We provide recommendations to design senior-friendly Web-based applications for a new approach to multicomponent cardiovascular prevention. The development of the platform followed five phases: (1) conceptual framework; (2) platform concept and functional design; (3) platform building (software and content); (4) testing and pilot study; and (5) final product. We performed a meta-analysis, reviewed guidelines for cardiovascular diseases, and consulted end users, experts, and software developers to create the platform concept and content. The software was built in iterative cycles. In the pilot study, 41 people aged ≥65 years used the platform for 8 weeks. Participants used the interactive features of the platform and appreciated the coach support. During all phases adjustments were made to incorporate all improvements from the previous phases. The final platform is a personal, secured, and interactive platform supported by a coach. When carefully designed, an interactive Internet platform is acceptable and feasible for use by older people with basic computer skills. To improve acceptability by older people, we recommend involving the end users in the process of development, to personalize the platform and to combine the application with human support. The interactive HATICE platform will be tested for efficacy in a multinational randomized controlled trial (ISRCTN48151589).

 


Development of a theory-informed implementation intervention to improve the triage, treatment and transfer of stroke patients in emergency departments using the Theoretical Domains Framework (TDF): the T(3) Trial.

Louise Craig, Natalie Taylor, Rohan Grimley, Dominique Cadilhac, Elizabeth McInnes, Rosemary Phillips, Simeon Dale, Denise O'Connor, Chris Levi, Mark Fitzgerald, Julie Considine, Jeremy Grimshaw, Richard Gerraty, N Wah Cheung, Jeanette Ward, Sandy Middleton

Implementation science : IS [12:88] (2017)

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Theoretical frameworks and models based on behaviour change theories are increasingly used in the development of implementation interventions. Development of an implementation intervention is often based on the available evidence base and practical issues, i.e. feasibility and acceptability. The aim of this study was to describe the development of an implementation intervention for the T(3) Trial (Triage, Treatment and Transfer of patients with stroke in emergency departments (EDs)) using theory to recommend behaviour change techniques (BCTs) and drawing on the research evidence base and practical issues of feasibility and acceptability. A stepped method for developing complex interventions based on theory, evidence and practical issues was adapted using the following steps: (1) Who needs to do what, differently? (2) Using a theoretical framework, which barriers and enablers need to be addressed? (3) Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? A researcher panel was convened to review the list of BCTs recommended for use and to identify the most feasible and acceptable techniques to adopt. Seventy-six barriers were reported by hospital staff who attended the workshops (step 1: thirteen TDF domains likely to influence the implementation of the T(3) Trial clinical intervention were identified by the researchers; step 2: the researcher panellists then selected one third of the BCTs recommended for use as appropriate for the clinical context of the ED and, using the enabler workshop data, devised enabling strategies for each of the selected BCTs; and step 3: the final implementation intervention consisted of 27 BCTs). The TDF was successfully applied in all steps of developing an implementation intervention for the T(3) Trial clinical intervention. The use of researcher panel opinion was an essential part of the BCT selection process to incorporate both research evidence and expert judgment. It is recommended that this stepped approach (theory, evidence and practical issues of feasibility and acceptability) is used to develop highly reportable implementation interventions. The classifying of BCTs using recognised implementation intervention components will facilitate generalisability and sharing across different conditions and clinical settings.

 


Using a behaviour change techniques taxonomy to identify active ingredients within trials of implementation interventions for diabetes care.

Justin Presseau, Noah Ivers, James Newham, Keegan Knittle, Kristin Danko, Jeremy Grimshaw

Implementation science : IS [10:55] (2015)

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Methodological guidelines for intervention reporting emphasise describing intervention content in detail. Despite this, systematic reviews of quality improvement (QI) implementation interventions continue to be limited by a lack of clarity and detail regarding the intervention content being evaluated. We aimed to apply the recently developed Behaviour Change Techniques Taxonomy version 1 (BCTTv1) to trials of implementation interventions for managing diabetes to assess the capacity and utility of this taxonomy for characterising active ingredients. Three psychologists independently coded a random sample of 23 trials of healthcare system, provider- and/or patient-focused implementation interventions from a systematic review that included 142 such studies. Intervention content was coded using the BCTTv1, which describes 93 behaviour change techniques (BCTs) grouped within 16 categories. We supplemented the generic coding instructions within the BCTTv1 with decision rules and examples from this literature. Less than a quarter of possible BCTs within the BCTTv1 were identified. For implementation interventions targeting providers, the most commonly identified BCTs included the following: adding objects to the environment, prompts/cues, instruction on how to perform the behaviour, credible source, goal setting (outcome), feedback on outcome of behaviour, and social support (practical). For implementation interventions also targeting patients, the most commonly identified BCTs included the following: prompts/cues, instruction on how to perform the behaviour, information about health consequences, restructuring the social environment, adding objects to the environment, social support (practical), and goal setting (behaviour). The BCTTv1 mapped well onto implementation interventions directly targeting clinicians and patients and could also be used to examine the impact of system-level interventions on clinician and patient behaviour. The BCTTv1 can be used to characterise the active ingredients in trials of implementation interventions and provides specificity of content beyond what is given by broader intervention labels. Identification of BCTs may provide a more helpful means of accumulating knowledge on the content used in trials of implementation interventions, which may help to better inform replication efforts. In addition, prospective use of a behaviour change techniques taxonomy for developing and reporting intervention content would further aid in building a cumulative science of effective implementation interventions.

 


A novel behavioral intervention in adolescents with type 1 diabetes mellitus improves glycemic control: preliminary results from a pilot randomized control trial.

Louise Maranda, May Lau, Sunita Stewart, Olga Gupta

The Diabetes educator [41:224-30] (2015)

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The purpose of this study was to develop and pilot-test an innovative behavioral intervention in adolescents with type 1 diabetes mellitus (T1DM) incorporating structured care of a pet to improve glycemic control. Twenty-eight adolescents with A1C > 8.5% (69 mmol/mol) were randomly assigned to either the intervention group (care of a Betta splendens pet fish) or the control group (usual care). Adolescents in the intervention group were given instructions to associate daily and weekly fish care duties with diabetes self-management tasks, including blood glucose testing and parent-adolescent communication. After 3 months, the participants in the intervention group exhibited a statistically significant decrease in A1C level (-0.5%) compared with their peers in the control group, who had an increase in A1C level (0.8%) (P = .04). The younger adolescents (10-13 years of age) demonstrated a greater response to the intervention, which was statistically significant (-1.5% vs 0.6%, P = .04), compared with the older adolescents (14-17 years of age). Structured care of a pet fish can improve glycemic control in adolescents with T1DM, likely by providing cues to perform diabetes self-management behaviors.

 


Characterizing Active Ingredients of eHealth Interventions Targeting Persons With Poorly Controlled Type 2 Diabetes Mellitus Using the Behavior Change Techniques Taxonomy: Scoping Review.

Mihiretu Kebede, Tatjana Liedtke, Tobias Möllers, Claudia Pischke

Journal of medical Internet research [19:e348] (2017)

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The behavior change technique taxonomy v1 (BCTTv1; Michie and colleagues, 2013) is a comprehensive tool to characterize active ingredients of interventions and includes 93 labels that are hierarchically clustered into 16 hierarchical clusters. The aim of this study was to identify the active ingredients in electronic health (eHealth) interventions targeting patients with poorly controlled type 2 diabetes mellitus (T2DM) and relevant outcomes. We conducted a scoping review using the BCTTv1. Randomized controlled trials (RCTs), studies with or pre-post-test designs, and quasi-experimental studies examining efficacy and effectiveness of eHealth interventions for disease management or the promotion of relevant health behaviors were identified by searching PubMed, Web of Science, and PsycINFO. Reviewers independently screened titles and abstracts for eligibility using predetermined eligibility criteria. Data were extracted following a data extraction sheet. The BCTTv1 was used to characterize active ingredients of the interventions reported in the included studies. Of the 1404 unique records screened, 32 studies fulfilled the inclusion criteria and reported results on the efficacy and or or effectiveness of interventions. Of the included 32 studies, 18 (56%) were Web-based interventions delivered via personal digital assistant (PDA), tablet, computer, and/or mobile phones; 7 (22%) were telehealth interventions delivered via landline; 6 (19%) made use of text messaging (short service message, SMS); and 1 employed videoconferencing (3%). Of the 16 hierarchical clusters of the BCTTv1, 11 were identified in interventions included in this review. Of the 93 individual behavior change techniques (BCTs), 31 were identified as active ingredients of the interventions. The most common BCTs identified were instruction on how to perform behavior, adding objects to the environment, information about health consequences, self-monitoring of the outcomes and/or and prefers to be explicit to avoid ambiguity. Response: Checked and avoided of a certain behavior Author: Please note that the journal discourages the use of parenthesis to denote either and/or and prefers to be explicit to avoid ambiguity. Response: Checked and avoided "and/or" and prefers to be explicit to avoid ambiguity. Response: Checked and avoided, and feedback on outcomes of behavior. Our results suggest that the majority of BCTs employed in interventions targeting persons with T2DM revolve around the promotion of self-regulatory behavior to manage the disease or to assist patients in performing health behaviors necessary to prevent further complications of the disease. Detailed reporting of the BCTs included in interventions targeting this population may facilitate the replication and further investigation of such interventions.

 


Intervention planning for a digital intervention for self-management of hypertension: a theory-, evidence- and person-based approach.

Rebecca Band, Katherine Bradbury, Katherine Morton, Carl May, Susan Michie, Frances Mair, Elizabeth Murray, Richard McManus, Paul Little, Lucy Yardley

Implementation science : IS [12:25] (2017)

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This paper describes the intervention planning process for the Home and Online Management and Evaluation of Blood Pressure (HOME BP), a digital intervention to promote hypertension self-management. It illustrates how a Person-Based Approach can be integrated with theory- and evidence-based approaches. The Person-Based Approach to intervention development emphasises the use of qualitative research to ensure that the intervention is acceptable, persuasive, engaging and easy to implement. Our intervention planning process comprised two parallel, integrated work streams, which combined theory-, evidence- and person-based elements. The first work stream involved collating evidence from a mixed methods feasibility study, a systematic review and a synthesis of qualitative research. This evidence was analysed to identify likely barriers and facilitators to uptake and implementation as well as design features that should be incorporated in the HOME BP intervention. The second work stream used three complementary approaches to theoretical modelling: developing brief guiding principles for intervention design, causal modelling to map behaviour change techniques in the intervention onto the Behaviour Change Wheel and Normalisation Process Theory frameworks, and developing a logic model. The different elements of our integrated approach to intervention planning yielded important, complementary insights into how to design the intervention to maximise acceptability and ease of implementation by both patients and health professionals. From the primary and secondary evidence, we identified key barriers to overcome (such as patient and health professional concerns about side effects of escalating medication) and effective intervention ingredients (such as providing in-person support for making healthy behaviour changes). Our guiding principles highlighted unique design features that could address these issues (such as online reassurance and procedures for managing concerns). Causal modelling ensured that all relevant behavioural determinants had been addressed, and provided a complete description of the intervention. Our logic model linked the hypothesised mechanisms of action of our intervention to existing psychological theory. Our integrated approach to intervention development, combining theory-, evidence- and person-based approaches, increased the clarity, comprehensiveness and confidence of our theoretical modelling and enabled us to ground our intervention in an in-depth understanding of the barriers and facilitators most relevant to this specific intervention and user population.

 


Web-based self-management with and without coaching for type 2 diabetes patients in primary care: design of a randomized controlled trial.

Michael van Vugt, Maartje de Wit, Steven Hendriks, Yvonne Roelofsen, Henk Bilo, Frank Snoek

BMC endocrine disorders [13:53] (2013)

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Self-management is recognized as the cornerstone of overall diabetes management. Web-based self-management programs have the potential of supporting type 2 diabetes patients with managing their diabetes and reducing the workload for the care provider, where the addition of online coaching could improve patient motivation and reduce program attrition. This study aims to test the hypothesis that a web-based self-management program with coaching will prove more effective on improving patient self-management behavior and clinical outcome measures than a web-based self-management program without coaching. The effects of a web-based self-management program with and without coaching will be tested with a nested randomized controlled trial within a healthcare group in the Netherlands. In one year 220 type 2 diabetes patients will be randomized into an intervention group (n = 110) or a control group (n = 110). The control group will receive only the online self-management program. The intervention group will receive the online self-management program and additional online coaching. Participants will be followed for one year, with follow-up measurements at 6 and 12 months. The intervention being tested is set to support type 2 diabetes patients with their diabetes self-management and is expected to have beneficial effects on self-care activities, well being and clinical outcomes. When proven effective this self-management support program could be offered to other health care groups and their type 2 diabetes patients in the Netherlands. Nederlands Trial Register NTR4064.

 


Partner- and planning-based interventions to reduce fat consumption: randomized controlled trial.

Andrew Prestwich, Mark Conner, Rebecca Lawton, Jane Ward, Karen Ayres, Rosemary McEachan

British journal of health psychology [19:132-48] (2014)

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The research tested the efficacy of partner- and planning-based interventions to reduce dietary fat intake over a 6-month period. Randomized controlled, blinded, parallel trial. A computer randomization feature was used to allocate council employees (N = 427, of which 393 completed baseline measures) to one of four conditions (partner + implementation intentions, partner-only, implementation intentions, and control group) before they completed measures at baseline and follow-ups at 1, 3, and 6 months post-baseline. Outcome measures were comprised of validated self-report measures of dietary fat intake (saturated fat intake, fat intake, ratio of 'good' fats to 'bad' fats); psychosocial mediators (enjoyment, intention, self-efficacy, social influence, partner support); weight and waist size (baseline and 6 months only). Data from 393 participants were analysed in accordance with intention-to-treat analyses. All intervention groups reported greater reductions in fat intake than the control group at 3 months. The partner-based groups increased the ratio of 'good' fats to 'bad' fats at 3 and 6 months and lost more inches on their waist, versus the non-partner groups. The impacts of the partner-based manipulations on outcomes were partially mediated by greater perceived social influences, partner support, and enjoyment of avoiding high-fat foods. The partner-based interventions also increased intention and self-efficacy. However, the effects in this study were typically small and generally marginally significant. Partner-based interventions had some positive benefits on dietary-related outcomes at 3 and 6 months. Support for implementation intentions was more limited.

 


The impact of a computer-tailored nutrition intervention.

J Brug, I Steenhuis, Assema van, Hein De Vries

Preventive medicine [25:236-42] ()

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Nutrition education tailored to individual characteristics of people might be more effective than general nutrition education. Nowadays, the use of computers makes individualized feedback available for larger groups. The impact of tailored nutrition information on changes in fat, vegetable, and fruit consumption was tested in a randomized trial among 347 employees of a major oil company. Respondents in the experimental group received computer-generated feedback letters tailored to their personal dietary behavior, attitudes, perceived social influences, self-efficacy expectations, and awareness levels. Respondents in the control group received general nutrition information. Respondents in the experimental group decreased their fat consumption significantly more than the control group between baseline and posttest. A significant effect of tailoring was also found for changes in attitudes and intentions toward reducing fat intake and increasing fruit and vegetable consumption. Furthermore, respondents in the experimental group were more satisfied with the nutrition information they received and more often reported changing their diet or intention as a result of the information. It is concluded that computer-tailored nutrition information is a promising means of stimulating people to change their diet toward dietary recommendations.

 


The D-Net diabetes self-management program: long-term implementation, outcomes, and generalization results.

Russell Glasgow, Shawn Boles, H Garth McKay, Edward Feil, Manuel Barrera

Preventive medicine [36:410-9] (2003)

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A prerequisite to translating research findings into practice is information on consistency of implementation, maintenance of results, and generalization of effects. This follow-up report is one of the few experimental studies to provide such information on Internet-based health education. We present follow-up data 10 months following randomization on the "Diabetes Network (D-Net)" Internet-based self-management project, a randomized trial evaluating the incremental effects of adding (1) tailored self-management training or (2) peer support components to a basic Internet-based, information-focused comparison intervention. Participants were 320 adult type 2 diabetes patients from participating primary care offices, mean age 59 (SD = 9.2), who were relatively novice Internet users. All intervention components were consistently implemented by staff, but participant website usage decreased over time. All conditions were significantly improved from baseline on behavioral, psychosocial, and some biological outcomes; and there were few differences between conditions. Results were robust across on-line coaches, patient characteristics, and participating clinics. The basic D-Net intervention was implemented well and improvements were observed across a variety of patients, interventionists, and clinics. There were, however, difficulties in maintaining usage over time and additions of tailored self-management and peer support components generally did not significantly improve results.

 


Nutrition intervention for high-risk auto workers: results of the Next Step Trial.

B Tilley, K Glanz, A Kristal, K Hirst, S Li, S Vernon, R Myers

Preventive medicine [28:284-92] (1999)

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The Next Step Trial tested interventions encouraging prevention and early detection practices in automotive-industry employees at increased colorectal cancer risk. This article describes results of the nutrition intervention promoting low-fat, high-fiber eating patterns. Twenty-eight worksites (5,042 employees at baseline) were randomized to a 2-year nutrition intervention including classes, mailed self-help materials, and personalized dietary feedback. Control worksites received no intervention. Nutrition outcomes were assessed by mailed food frequency questionnaires (FFQs) Primary nutrition outcomes included percentage energy from fat and fiber density (g/1,000 kcal) at 1 year postrandomization. Secondary outcomes included servings of fruits/vegetables and dietary measures at 2 years postrandomization. Analyses were adjusted for within worksite correlations and baseline covariates. Fifty-eight percent of employees returned FFQs. At 1 year, there were modest but statistically significant intervention effects for fat (-0.9 %en), fiber (+0.5 g/1,000 kcal), and fruits/vegetables (+0.2 servings/day) (all P < 0.007). At 2 years, due to significant positive changes in control worksites, intervention effects were smaller, significant for fiber only. Intervention effects were larger in younger (<50 years), active employees and class attendees. The nutrition intervention produced significant but modest effects on dietary fat and fiber and fruits/vegetables in these high-risk employees. Age and dose effects suggest younger employees may be more responsive to this intervention.

 


Behaviour change techniques targeting both diet and physical activity in type 2 diabetes: A systematic review and meta-analysis.

Kevin Cradock, Gearóid ÓLaighin, Francis Finucane, Heather Gainforth, Leo Quinlan, Kathleen A Martin Ginis

The international journal of behavioral nutrition and physical activity [14:18] (2017)

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Changing diet and physical activity behaviour is one of the cornerstones of type 2 diabetes treatment, but changing behaviour is challenging. The objective of this study was to identify behaviour change techniques (BCTs) and intervention features of dietary and physical activity interventions for patients with type 2 diabetes that are associated with changes in HbA1c and body weight. We performed a systematic review of papers published between 1975-2015 describing randomised controlled trials (RCTs) that focused exclusively on both diet and physical activity. The constituent BCTs, intervention features and methodological rigour of these interventions were evaluated. Changes in HbA1c and body weight were meta-analysed and examined in relation to use of BCTs. Thirteen RCTs were identified. Meta-analyses revealed reductions in HbA1c at 3, 6, 12 and 24 months of -1.11 % (12 mmol/mol), -0.67 % (7 mmol/mol), -0.28 % (3 mmol/mol) and -0.26 % (2 mmol/mol) with an overall reduction of -0.53 % (6 mmol/mol [95 % CI -0.74 to -0.32, P < 0.00001]) in intervention groups compared to control groups. Meta-analyses also showed a reduction in body weight of -2.7 kg, -3.64 kg, -3.77 kg and -3.18 kg at 3, 6, 12 and 24 months, overall reduction was -3.73 kg (95 % CI -6.09 to -1.37 kg, P = 0.002). Four of 46 BCTs identified were associated with >0.3 % reduction in HbA1c: 'instruction on how to perform a behaviour', 'behavioural practice/rehearsal', 'demonstration of the behaviour' and 'action planning', as were intervention features 'supervised physical activity', 'group sessions', 'contact with an exercise physiologist', 'contact with an exercise physiologist and a dietitian', 'baseline HbA1c >8 %' and interventions of greater frequency and intensity. Diet and physical activity interventions achieved clinically significant reductions in HbA1c at three and six months, but not at 12 and 24 months. Specific BCTs and intervention features identified may inform more effective structured lifestyle intervention treatment strategies for type 2 diabetes.

 


Cancer prevention for working class, multi-ethnic populations through health centers: the healthy directions study.

Karen Emmons, Anne Stoddard, Caitlin Gutheil, Elizabeth Suarez, Rebecca Lobb, Robert Fletcher

Cancer causes & control : CCC [14:727-37] (2003)

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This paper presents the study design and baseline data from Healthy Directions-Health Centers (HCs), a study designed to address social contextual factors in cancer prevention interventions for working class, multi-ethnic populations. This study is part of the Harvard Cancer Prevention Program Project. Ten community HCs were paired and randomly assigned to intervention or control. Patients who resided in low income, multi-ethnic neighborhoods were identified and approached for participation. This study targeted fruit and vegetable consumption, red meat consumption, multi-vitamin intake, and physical activity. The intervention components consisted of: (1) a brief in-person study endorsement from the participant's clinician at a scheduled routine care visit; (2) an initial in-person counseling session with a health advisor; (3) four follow-up telephone counseling sessions; (4) multiple mailings of tailored materials; and (5) linkages to relevant activities in the local community. Fifteen percent of the sample smoked, 86% reported eating fewer than five servings of fruits and vegetables per day, 50% reported eating more than the recommended amounts of red meat, 40% did not meet recommended physical activity levels, and 63% did not take a multi-vitamin on a daily basis. Although overall social support was high, participants reported low levels of social norms for the target prevention behaviors. Other social contextual mediators and modifying factors are reported. By examining the relationships between social contextual factors and health behaviors, it may be possible to enhance the effectiveness of interventions aimed at reducing social inequalities in risk behaviors.

 



Demonstration of an E-mailed worksite nutrition intervention program.

Gladys Block, Torin Block, Patricia Wakimoto, Clifford Block

Preventing chronic disease [1:A06] (2004)

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Dietary fat and low fruit and vegetable intake are linked to many chronic diseases, and U.S. population intake does not meet recommendations. Interventions are needed that incorporate effective behavior-change principles and that can be delivered inexpensively to large segments of the population. Employees at a corporate worksite were invited to participate in a program, delivered entirely by e-mail, to reduce dietary fat and increase fruit and vegetable intake. Behavior-change principles underlying the intervention included tailoring to the participant's dietary lifestyle, baseline assessment and feedback about dietary intake, family participation, and goal setting. Assessment, tailoring, and delivery was fully automated. The program was delivered weekly to participants' e-mail inboxes for 12 weeks. Each e-mail included information on nutrition or on the relationship between diet and health, dietary tips tailored to the individual, and small goals to try for the next week. In this nonrandomized pilot study, we assessed technical feasibility, acceptability to employees, improvement in Stage of Change, increase in fruit and vegetable consumption, and decrease in fat intake. Approximately one third (n = 84) of employees who were offered the 12-week program signed up for it, and satisfaction was high. There was significant improvement in Stage of Change: 74% of those not already at the top had forward movement (P < .001). In addition, results suggest significant increase in fruit and vegetable consumption (0.73 times/day, P < .001) and significant decrease in intake of fat sources (-0.39 times/day, P < .001). This inexpensive program is feasible and appears to be effective. A randomized controlled trial is needed.

 


ShopSmart 4 Health: results of a randomized controlled trial of a behavioral intervention promoting fruit and vegetable consumption among socioeconomically disadvantaged women.

Kylie Ball, Sarah McNaughton, Nd Le Ha, Gavin Abbott, Lena Stephens, David Crawford

The American journal of clinical nutrition (2016)

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Behavioral interventions show potential for promoting increased fruit and vegetable consumption in the general population. However, little is known about their effectiveness or cost-effectiveness among socioeconomically disadvantaged groups, who are less likely to consume adequate fruit and vegetables. This study investigated the effects and costs of a behavior change intervention for increasing fruit and vegetable purchasing and consumption among socioeconomically disadvantaged women. ShopSmart 4 Health was a randomized controlled trial involving a 3-mo retrospective baseline data collection phase [time (T) 0], a 6-mo intervention (T1-T2), and a 6-mo no-intervention follow-up (T3). Socioeconomically disadvantaged women who were primary household shoppers in Melbourne, Australia, were randomly assigned to either a behavior change intervention arm (n = 124) or a control arm (n = 124). Supermarket transaction (sales) data and surveys measured the main outcomes: fruit and vegetable purchases and self-reported fruit and vegetable consumption. An analysis of supermarket transaction data showed no significant intervention effects on vegetable or fruit purchasing at T2 or T3. Participants in the behavior change intervention arm reported consumption of significantly more vegetables during the intervention (T2) than did controls, with smaller intervention effects sustained at 6 mo postintervention (T3). Relative to controls, vegetable consumption increased by ∼0.5 serving · participant(-1) · d(-1) from baseline to T2 and remained 0.28 servings/d higher than baseline at T3 among those who received the intervention. There was no intervention effect on reported fruit consumption. The behavior change intervention cost A$3.10 (in Australian dollars) · increased serving of vegetables(-1) · d(-1)Conclusions: This behavioral intervention increased vegetable consumption among socioeconomically disadvantaged women. However, the lack of observed effects on fruit consumption and on both fruit and vegetable purchasing at intervention stores suggests that further investigation of effective nutrition promotion approaches for this key target group is required. The ShopSmart 4 Health trial was registered at www.isrctn.com as ISRCTN48771770.

 



Promoting healthy weight with "stability skills first": a randomized trial.

Michaela Kiernan, Susan Brown, Danielle Schoffman, Katherine Lee, Abby King, C Barr Taylor, Nina Schleicher, Michael Perri

Journal of consulting and clinical psychology [81:336-46] (2013)

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Although behavioral weight-loss interventions produce short-term weight loss, long-term maintenance remains elusive. This randomized trial examined whether learning a novel set of "stability skills" before losing weight improved long-term weight management. Stability skills were designed to optimize individuals' current satisfaction with lifestyle and self-regulatory habits while requiring the minimum effort and attention necessary. Overweight/obese women (N = 267) were randomly assigned to one of two 6-month interventions and assessed at baseline and at 6, 12, and 18 months. Maintenance First women participated first in an 8-week stability skills maintenance module and then in a standard 20-week behavioral weight-loss program. Weight Loss First women participated first in a standard 20-week behavioral weight-loss program and then in a standard 8-week problem-solving skills maintenance module. There was no intervention staff contact during the 12-month follow-up period (6-18 months). As designed, Maintenance First participants lost the same percentage of initial weight during the 6-month intervention period as Weight Loss First participants (M = -8.6%, SD = 5.7, vs. M = -9.1%, SD = 6.9; t = -0.6, p = .52). However, Maintenance First participants regained significantly less weight during the 12-month follow-up period (6-18 months) than Weight Loss First participants (M = 3.2 lb, SD = 10.4, vs. M = 7.3 lb, SD = 9.9 [M = 1.4 kg, SD = 4.7, vs. M = 3.3 kg, SD = 4.5]; t = 3.3, p = .001, d = 0.4). Learning stability skills before losing weight was successful in helping women to maintain weight loss without intervention staff contact during follow-up. These results can inform the study design of future innovative interventions.

 


Toward the optimal strategy for sustained weight loss in overweight cancer survivors: a systematic review of the literature.

Meeke Hoedjes, Maartje M van Stralen, Sheena Tjon A Joe, Matti Rookus, Flora van Leeuwen, Susan Michie, Jacob Seidell, Ellen Kampman

Journal of cancer survivorship : research and practice (2017)

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To gain more insight into the optimal strategy to achieve weight loss and weight loss maintenance in overweight and obese cancer survivors after completion of initial treatment, this systematic review aimed to provide an overview of the literature on intervention effects on weight, to describe intervention components used in effective interventions, to identify and synthesize behaviour change techniques (BCTs) and to assess the frequency with which these BCTs were used in effective interventions. Six databases were searched for original research articles describing weight changes in adult overweight cancer survivors after participation in a lifestyle intervention initiated after completion of initial treatment. Two researchers independently screened the retrieved papers and extracted BCTs using the BCT Taxonomy version 1. Thirty-two papers describing 27 interventions were included. Interventions that were evaluated with a robust study design (n = 8) generally showed <5% weight loss and did not evaluate effects at ≥12 months after intervention completion. Effective interventions promoted both diet and physical activity and used the BCTs 'goal setting (behaviour)', 'action planning', 'social support (unspecified)' and 'instruction on how to perform the behaviour'. The results of this first review on intervention components of effective interventions could be used to inform intervention development and showed a need for future publications to report long-term effects, a detailed intervention description and an extensive process evaluation. This study contributed to increasing knowledge on the optimal strategy to achieve weight loss, which is recommended for overweight cancer survivors to improve health outcomes.

 


Development of the SALdável programme to reduce salt intake among hypertensive Brazilian women: an intervention mapping approach.

Marilia Cornélio, Gaston Godin, Roberta Rodrigues, Rúbia Agondi, Thaís Spana, Maria-Cecilia Gallani

European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology [12:385-92] (2013)

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Despite strong evidence for a relationship between high salt intake and hypertension, plus the widespread recommendations for dietary salt restriction among hypertensive subjects, there are no nursing studies describing effective theory-based interventions. To describe a systematic process for development of a theory-based nursing intervention that is aimed at reducing salt intake among hypertensive women, by applying the 'intervention mapping' protocol. We developed our intervention following the six steps of the 'intervention mapping' protocol: assessing needs, creating a matrix of change objectives, selecting theoretical methods and practical applications, defining the intervention programme, organizing the adoption and implementation plan, and defining the evaluation plan. Addition of salt during cooking is identified as the main source for salt consumption, plus women are identified as the people responsible for cooking meals at home. In our study, the motivational predictors of this behaviour were self-efficacy and habit. Guided practice, verbal persuasion, coping barriers, consciousness-raising and counter-conditioning were the theoretical methods we selected for enhancing self-efficacy and promoting habit change, respectively. Brainstorming, role-playing, cookbook use, measuring spoon use, label reading, hands-on skill-building activities and reinforcement phone calls were the chosen practical applications. We designed our intervention programme, and then organized the adoption and implementation plans. Finally, we generated a plan to evaluate our intervention. 'Intervention mapping' was a feasible methodological framework to guide the development of a theory-based nursing intervention for dietary salt reduction among hypertensive women.

 



Development of an Evidence-Informed Blog to Promote Healthy Eating Among Mothers: Use of the Intervention Mapping Protocol.

Audrée-Anne Dumas, Simone Lemieux, Annie Lapointe, Véronique Provencher, Julie Robitaille, Sophie Desroches

JMIR research protocols [6:e92] (2017)

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Low adherence to dietary guidelines and a concurrent rise of obesity-related chronic diseases emphasize the need for effective interventions to promote healthy eating. There is growing recognition that behavior change interventions should draw on theories of behavior change. Online interventions grounded in theory lead to increased effectiveness for health behavior change; however, few theory-driven social media-based health promotion interventions have been described in the literature. The objective of this study was to describe the application of the Intervention Mapping (IM) protocol to develop an evidence-informed blog to promote healthy eating among French-Canadian mothers of preschool and school-aged children. The following six steps of the IM protocol were performed. In Step 1, a preliminary needs assessment included a literature search on theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults (ie, knowledge, beliefs about capabilities, beliefs about consequences, intention/goals) and a qualitative study including focus groups to identify female Internet users' perceptions of their use of healthy eating blogs. In Step 2, two behavioral outcomes were selected (ie, increase daily intakes of Vegetables and Fruits and Milk and Alternatives of mothers to reach Canadian dietary recommendations) and subsequently divided into six performance objectives inspired by national and international dietary recommendations such as planning for healthy meals. A matrix of change objectives was then created by crossing performance objectives with theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults. Step 3 consisted of selecting theory-based intervention methods (eg, modeling and goal setting) and translating them into practical applications for the context of a dietary intervention delivered through a blog. A 6-month intervention was developed in Step 4 in which we aimed to address one performance objective per month in weekly blog publications written by a registered dietitian. For Step 5, we sought to include engagement-promoting methods (eg, peer and counselor support) to promote mothers' use of the blog and adherence to the intervention. Finally in Step 6, a randomized controlled trial has been launched to evaluate the effects of the blog on dietary behaviors of French-Canadian mothers. The intervention study is expected to be completed in March 2018. An intervention mapping protocol allowed for effective decision making in the development of a novel knowledge translation tool to increase adherence to dietary recommendations among mothers of preschool and school-aged children.

 


Development and preliminary evaluation of an internet-based healthy eating program: randomized controlled trial.

Katy Tapper, Gabriela Jiga-Boy, Gregory Maio, Geoffrey Haddock, Michael Lewis

Journal of medical Internet research [16:e231] (2014)

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The HealthValues Healthy Eating Programme is a standalone Internet-based intervention that employs a novel strategy for promoting behavior change (analyzing one's reasons for endorsing health values) alongside other psychological principles that have been shown to influence behavior. The program consists of phases targeting motivation (dietary feedback and advice, analyzing reasons for health values, thinking about health-related desires, and concerns), volition (implementation intentions with mental contrasting), and maintenance (reviewing tasks, weekly tips). The aim was to examine the effects of the program on consumption of fruit and vegetables, saturated fat, and added sugar over a 6-month period. A total of 82 females and 18 males were recruited using both online and print advertisements in the local community. They were allocated to an intervention or control group using a stratified block randomization protocol. The program was designed such that participants logged onto a website every week for 24 weeks and completed health-related measures. Those allocated to the intervention group also completed the intervention tasks at these sessions. Additionally, all participants attended laboratory sessions at baseline, 3 months, and 6 months. During these sessions, participants completed a food frequency questionnaire (FFQ, the Block Fat/Sugar/Fruit/Vegetable Screener, adapted for the UK), and researchers (blind to group allocation) measured their body mass index (BMI), waist-to-hip ratio (WHR), and heart rate variability (HRV). Data were analyzed using a series of ANOVA models. Per protocol analysis (n=92) showed a significant interaction for fruit and vegetable consumption (P=.048); the intervention group increased their intake between baseline and 6 months (3.7 to 4.1 cups) relative to the control group (3.6 to 3.4 cups). Results also showed overall reductions in saturated fat intake (20.2 to 15.6 g, P

 


What motivates maternal and child nutrition peer educators? Experiences of fathers and grandmothers in western Kenya.

Stephanie Martin, Teresia Muhomah, Faith Thuita, Allison Bingham, Altrena Mukuria

Social science & medicine (1982) [143:45-53] (2015)

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Peer-led dialogue groups (i.e., support or self-help groups) are a widely used community-based strategy to improve maternal and child health and nutrition. However, the experiences and motivation of peer educators who facilitate these groups are not well documented. We implemented eight father and ten grandmother peer dialogue groups in western Kenya to promote and support recommended maternal dietary and infant and young child feeding practices and sought to understand factors that influenced peer educator motivation. After four months of implementation, we conducted 17 in-depth interviews with peer educators as part of a process evaluation to understand their experiences as group facilitators as well as their motivation. We analyzed the interview transcripts thematically and then organized them by level: individual, family, peer dialogue group, organization, and community. Father and grandmother peer educators reported being motivated by multiple factors at the individual, family, dialogue group, and community levels, including increased knowledge, improved communication with their wives or daughters-in-law, increased respect and appreciation from their families, group members' positive changes in behavior, and increased recognition within their communities. This analysis also identified several organization-level factors that contributed to peer educator motivation, including clearly articulated responsibilities for peer educators; strong and consistent supportive supervision; opportunities for social support among peer educators; and working within the existing health system structure. Peer educator motivation affects performance and retention, which makes understanding and responding to their motivation essential for the successful implementation, sustainability, and scalability of community-based, peer-led nutrition interventions.

 



Healthy whole-grain choices for children and parents: a multi-component school-based pilot intervention.

Teri Burgess-Champoux, Hing Wan Chan, Renee Rosen, Len Marquart, Marla Reicks

Public health nutrition [11:849-59] (2008)

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The aim of the present study was to pilot-test a school-based intervention designed to increase consumption of whole grains by 4th and 5th grade children. This multi-component school-based pilot intervention utilised a quasi-experimental study design (intervention and comparison schools) that consisted of a five-lesson classroom curriculum based on Social Cognitive Theory, school cafeteria menu modifications to increase the availability of whole-grain foods and family-oriented activities. Meal observations of children estimated intake of whole grains at lunch. Children and parents completed questionnaires to assess changes in knowledge, availability, self-efficacy, usual food choice and role modelling. Parent/child pairs from two schools in the Minneapolis metropolitan area; 67 in the intervention and 83 in the comparison school. Whole-grain consumption at the lunch meal increased by 1 serving (P < 0.0001) and refined-grain consumption decreased by 1 serving for children in the intervention school compared with the comparison school post-intervention (P < 0.001). Whole-grain foods were more available in the lunches served to children in the intervention school compared with the comparison school post-intervention (P < 0.0001). The ability to identify whole-grain foods by children in both schools increased, with a trend towards a greater increase in the intervention school (P = 0.06). Parenting scores for scales for role modelling (P < 0.001) and enabling behaviours (P < 0.05) were significantly greater for parents in the intervention school compared with the comparison school post-intervention. The multi-component school-based programme implemented in the current study successfully increased the intake of whole-grain foods by children.

 


Comparing the effectiveness of an enhanced MOtiVational intErviewing InTervention (MOVE IT) with usual care for reducing cardiovascular risk in high risk subjects: study protocol for a randomised controlled trial.

Adam Bayley, Nicole de Zoysa, Derek Cook, Peter Whincup, Daniel Stahl, Katherine Twist, Katie Ridge, Paul McCrone, Janet Treasure, Mark Ashworth, Anne Greenough, Clare Blythe, Kirsty Winkley, Khalida Ismail

Trials [16:112] (2015)

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Interventions targeting multiple risk factors for cardiovascular disease (CVD), including poor diet and physical inactivity, are more effective than interventions targeting a single risk factor. A motivational interviewing (MI) intervention can provide modest dietary improvements and physical activity increases, while adding cognitive behaviour therapy (CBT) skills may enhance the effects of MI. We designed a randomised controlled trial (RCT) to examine whether specific behaviour change techniques integrating MI and CBT result in favourable changes in weight and physical activity in those at high risk of CVD. A group and individual intervention will be compared to usual care. A group intervention offers potential benefits from social support and may be more cost effective. Individuals aged between 40 and 74 years in 11 South London Clinical Commissioning Groups who are at high risk of developing CVD (≥20%) in the next 10 years will be recruited. A sample of 1,704 participants will be randomised to receive the enhanced MI intervention, delivered by trained healthy lifestyle facilitators (HLFs), in group or individual formats, in 10 sessions (plus an introductory session) over one year, or usual care. Randomisation will be conducted by King's College London Clinical Trials Unit and researchers collecting outcome data will be blinded to treatment allocation. At 12-month and 24-month follow-up assessments, primary outcomes will be change in weight and physical activity (average steps per day). Secondary outcomes include changes in low-density lipoprotein cholesterol and CVD risk score. Incidence of CVD events since baseline will be recorded. A process evaluation will be conducted to evaluate factors which impact on delivery, adherence and outcome. An economic evaluation will estimate relative cost-effectiveness of each type of intervention delivery. This RCT assesses the effectiveness of a healthy lifestyle intervention for people at high risk of CVD. Benefits of the study include the ethnic and socioeconomic diversity of the study population and that, via social support within the group setting and long-term follow-up period, the intervention offers the potential to support maintenance of a healthy lifestyle. This trial is registered with the ISRCTN registry (identifier: ISRCTN84864870, registered 15 May 2012).

 


Nutrition education worksite intervention for university staff: application of the health belief model.

Doris Abood, David Black, Diane Feral

Journal of nutrition education and behavior [35:260-7] ()

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To evaluate the efficacy of an 8-week worksite nutrition education intervention for university staff using the Health Belief Model (HBM) to promote healthful dietary behaviors that reduce risks for cardiovascular disease and cancer. 2 3 2 repeated measures baseline/posttest ex post facto research design. Staff employees were randomly assigned to treatment (n = 28) and control groups (n = 25). The intervention focused on specific health beliefs, nutrition knowledge, and dietary practices to demonstrate treatment effect. Dependent variables were specific health beliefs, nutrition knowledge, and dietary behaviors. Independent variables were demographic characteristics and group assignment. Tests of parametric assumptions, power analyses, analysis of variance, and Kuder-Richardson and Pearson product-moment coefficients were computed and specificity of treatment effects was assessed. Perceived benefits of healthy nutrition practices and nutrition knowledge related to cardiovascular disease and cancer significantly improved among the treatment participants, P <.001. Treatment group participants also significantly reduced total calories, fat, saturated fat, and cholesterol intake (each P <.001). The intervention appears to be related to treatment effects and significantly increased nutrition knowledge and decreased energy, fat, saturated fat, and cholesterol intake to levels consistent with national recommendations.

 


RCT of a theory-based intervention promoting healthy eating and physical activity amongst out-patients older than 65 years.

K Kelley, C Abraham

Social science & medicine (1982) [59:787-97] (2004)

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A randomised controlled trial was used to evaluate a theory-based health promotion intervention. The intervention, a healthy living booklet, was designed to promote healthy eating and physical activity amongst people aged over 65 years attending hospital out-patient clinics. The booklet employed persuasive arguments targeting the most proximal cognitive antecedents of behaviour specified by the theory of planned behaviour, as well as goal setting prompts. Participants (N = 252, average age=82) were randomly allocated to a control (patient satisfaction questionnaire) or intervention (healthy living booklet) group. Cognitions and behaviour were measured pre-intervention and at a two week follow up. The intervention group made significantly higher gains in perceived behavioural control, intention and behaviour for both target behaviours, suggesting that the intervention was successful. Sixty three of those invited to set goals to eat more healthily (e.g., "to eat five portions of fruit and vegetables a day") did so, and 67% of those who set such goals reported 100% success in acting on them. By contrast, only 34% of intervention participants set an activity goal (e.g., "a five minute walk everyday"), and only 51% reported 100% success in enacting these goals. Results suggest that the observed behavioural effects of the healthy eating booklet could be attributed to goal setting as well as changes in perceived behavioural control and intention.

 


Promoting fruit and vegetable consumption. Testing an intervention based on the theory of planned behaviour.

E Kothe, B Mullan, P Butow

Appetite [58:997-1004] (2012)

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This study evaluated the efficacy of a theory of planned behaviour (TPB) based intervention to increase fruit and vegetable consumption. The extent to which fruit and vegetable consumption and change in intake could be explained by the TPB was also examined. Participants were randomly assigned to two levels of intervention frequency matched for intervention content (low frequency n=92, high frequency n=102). Participants received TPB-based email messages designed to increase fruit and vegetable consumption, messages targeted attitude, subjective norm and perceived behavioural control (PBC). Baseline and post-intervention measures of TPB variables and behaviour were collected. Across the entire study cohort, fruit and vegetable consumption increased by 0.83 servings/day between baseline and follow-up. Intention, attitude, subjective norm and PBC also increased (p<.05). The TPB successfully modelled fruit and vegetable consumption at both time points but not behaviour change. The increase of fruit and vegetable consumption is a promising preliminary finding for those primarily interested in increasing fruit and vegetable consumption. However, those interested in theory development may have concerns about the use of this model to explain behaviour change in this context. More high quality experimental tests of the theory are needed to confirm this result.

 


Correlational study and randomised controlled trial for understanding and changing red meat consumption: The role of eating identities.

V Carfora, D Caso, M Conner

Social science & medicine (1982) [175:244-252] (2017)

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The present studies aimed to contribute to the literature on psychological variables involved in reducing red meat consumption (RMC). Study 1 investigated whether the theory of planned behaviour (TPB), plus healthy-eating and meat-eating identities, could explain intentions to reduce RMC. Study 2 evaluated the effectiveness of an SMS text message intervention on self-monitoring to reduce RMC. In Study 1, data were collected daily using online food diaries for one week and a TPB questionnaire. Study 2 was a randomised controlled trial assessing pre- and post-RMC and TPB constructs by online food diaries and questionnaires over a one-week period. Participants were Italian undergraduates in each study (Study 1: N = 405; Study 2: N = 244). In Study 2, participants were randomly allocated to control and message condition groups. Participants in the message condition group received a daily SMS, which reminded them to monitor RMC, while participants in the control group did not receive any message. Only students who completed all measures were considered in the analyses (Study 1: N = 342; Study 2: N = 228). Study 1 showed that affective and instrumental attitudes, perceived behavioural control, and meat-eating identity explained intentions to reduce RMC, while subjective norm, past behaviour, and healthy-eating identity did not. Study 2 showed that an SMS intervention was effective in increasing intentions and reducing RMC. Mediation analyses indicated partial serial mediation through healthy-eating and meat-eating identities and intentions. The present studies provide support for the predictive validity of TPB in explaining intentions to reduce RMC and for the efficacy of an SMS intervention targeting self-monitoring in reducing RMC. Findings confirmed the important role of eating identities in explaining intentions to reduce RMC and in changing this behaviour.

 


Targeting Parents for Childhood Weight Management: Development of a Theory-Driven and User-Centered Healthy Eating App.

Kristina Curtis, Sudakshina Lahiri, Katherine Brown

JMIR mHealth and uHealth [3:e69] (2015)

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The proliferation of health promotion apps along with mobile phones' array of features supporting health behavior change offers a new and innovative approach to childhood weight management. However, despite the critical role parents play in children's weight related behaviors, few industry-led apps aimed at childhood weight management target parents. Furthermore, industry-led apps have been shown to lack a basis in behavior change theory and evidence. Equally important remains the issue of how to maximize users' engagement with mobile health (mHealth) interventions where there is growing consensus that inputs from the commercial app industry and the target population should be an integral part of the development process. The aim of this study is to systematically design and develop a theory and evidence-driven, user-centered healthy eating app targeting parents for childhood weight management, and clearly document this for the research and app development community. The Behavior Change Wheel (BCW) framework, a theoretically-based approach for intervention development, along with a user-centered design (UCD) philosophy and collaboration with the commercial app industry, guided the development process. Current evidence, along with a series of 9 focus groups (total of 46 participants) comprised of family weight management case workers, parents with overweight and healthy weight children aged 5-11 years, and consultation with experts, provided data to inform the app development. Thematic analysis of focus groups helped to extract information related to relevant theoretical, user-centered, and technological components to underpin the design and development of the app. Inputs from parents and experts working in the area of childhood weight management helped to identify the main target behavior: to help parents provide appropriate food portion sizes for their children. To achieve this target behavior, the behavioral diagnosis revealed the need for eliciting change in parents' capability, motivation, and opportunity in 10-associated Theoretical Domains Framework (TDF) domains. Of the 9 possible intervention functions, 6 were selected to bring about this change which guided the selection of 21 behavior change techniques. Parents' preferences for healthy eating app features revolved around four main themes (app features, time saving and convenience, aesthetics, and gamification) whereupon a criterion was applied to guide the selection on which preferences should be integrated into the design of the app. Collaboration with the app company helped to build on users' preferences for elements of gamification such as points, quizzes, and levels to optimize user engagement. Feedback from parents on interactive mock-ups helped to inform the final development of the prototype app. Here, we fully explicate a systematic approach applied in the development of a family-oriented, healthy eating health promotion app grounded in theory and evidence, and balanced with users' preferences to help maximize its engagement with the target population.

 


Why did soft drink consumption decrease but screen time not? Mediating mechanisms in a school-based obesity prevention program.

AP Chin, JM Marijke, AS Singh, J Brug, W van Mechelen

The international journal of behavioral nutrition and physical activity [5:41] (2008)

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This paper aims to identify the mediating mechanisms of a school-based obesity prevention program (DOiT). The DOiT-program was implemented in Dutch prevocational secondary schools and evaluated using a controlled, cluster-randomised trial (September 2003 to May 2004). We examined mediators of effects regarding (1) consumption of sugar containing beverages (SCB); (2) consumption of high caloric snacks; (3) screen-viewing behaviour; and (4) active commuting to school. To improve these behaviours the DOiT-program tried to influence the following potentially mediating variables: attitude, subjective norm, perceived behavioural control, and habit-strength. Both in boys (n = 418) and girls (n = 436) the DOiT-intervention reduced SCB consumption (between group difference in boys = -303.5 ml/day, 95% CI: -502.4;-104.5, between group difference in girls = -222.3 ml/day, 95% CI: -371.3;-73.2). The intervention did not affect the other examined behaviours. In girls, no intervention effect on hypothetical mediators was found nor evidence of any mediating mechanisms. Boys in intervention schools improved their attitude towards decreasing SCB consumption, while this behaviour became less of a habit. Indeed, attitude and habit strength were significant mediators of the DOiT-intervention's effect (4.5 and 3.8%, respectively) on SCB consumption among boys. Our findings imply that interventions aimed at EBRB-change should be gender-specific. Future studies aimed at reducing SCB consumption among boys should target attitude and habit strength as mediating mechanisms. Our study did not resolve the mediating mechanisms in girls. International Standard Randomised Controlled Trial Number Register ISRCTN87127361.

 


The feasibility phase of a community antenatal lifestyle programme [The Lifestyle Course (TLC)] for women with a body mass index (BMI)≥ 30 kg/m(2.).

Debbie Smith, Wendy Taylor, Melissa Whitworth, Stephen Roberts, Colin Sibley, Tina Lavender

Midwifery [31:280-7] (2015)

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maternal obesity [body mass index (BMI)≥30kg/m(2)] is a cause for concern because of increasing rates and risk of associated complications. However, little is known about how to improve the health of women with a BMI≥30kg/m(2). a 10-week antenatal lifestyle programme (The Lifestyle Course - TLC), underpinned by behaviour change theory, was developed in a programme of research which included a prospective, multicentred, feasibility phase (n=227). Participants had a BMI≥30kg/m(2) at the start of their pregnancy, planned to deliver in two areas of Greater Manchester and were aged 18 or over. The objectives were to (1) assess the feasibility of the intervention and (2) to pilot the trial processes and outcome measures. (1) Trial intervention: only 22% of women in the feasibility phase had received gestational weight advice prior to the study. One or more TLC sessions were attended by 79% of women and 97% said they would recommend TLC to a friend due to the content suitability, perceived personal gains and extra care received. Changes to the TLC were suggested and implemented in the pilot phase. (2) Trial processes: recruitment rates (36%), retention rates (100%) and questionnaire completion rates up to one year (33%) were found. Daily general 'lifestyle' diaries and pedometers were not acceptable data collection tools (response rates of 32% and 16% respectively). However, specific food diaries were acceptable (response rates of 80-81%). The major challenge was the collection of maternal weight data at the follow-up points. the antenatal intervention (TLC) designed for this programme of work appears to suit the needs of women with a BMI≥30kg/m(2). The need for an antenatal intervention is clear from this study and also highlights reflections on effective communication with pregnant women with a BMI≥30kg/m(2). Lessons learnt for designing a future trial include effective ways to communicate with pregnant women with a BMI≥30kg/m(2). ISRCTN29860479.

 


A randomised controlled trial and mediation analysis of the 'Healthy Habits', telephone-based dietary intervention for preschool children.

Amanda Fletcher, Luke Wolfenden, Rebecca Wyse, Jenny Bowman, Patrick McElduff, Sarah Duncan

The international journal of behavioral nutrition and physical activity [10:43] (2013)

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Consumption of non-core foods in childhood is associated with excessive weight gain in childhood. Parents play a vital role in establishing healthy diet behaviours in young children. The aim of this study was to assess the effectiveness of a telephone-based intervention in reducing child consumption of non-core foods, and to examine parent and home food environment mediators of change in child consumption. The 'Healthy Habits' trial utilised a clustered randomised controlled design. Parents were recruited from 30 preschools (N=394 participants, mean age 35.2±5.6 years). Parents randomized to the intervention group received four telephone contacts and print materials. Parents allocated to the control condition receive generic print materials only. Non-core food consumption was assessed using a validated child dietary questionnaire at baseline, 2 and 6 months post recruitment in 2010. The intervention was effective in reducing child consumption of non-core foods at 2 months (intention to treat analysis: z=-2.83, p<.01), however this effect was not maintained at 6 months. Structural equation modelling using 2 month data indicated that child access to non-core foods in the home and child feeding strategies mediated the effect of the intervention. The telephone-based intervention shows promise in improving short term dietary behaviour in preschool age children, however further development is needed to sustain the effect in the long-term. Australian Clinical Trials Registry: ACTRN12609000820202.

 




Randomised controlled trial of a text messaging intervention for reducing processed meat consumption: The mediating roles of anticipated regret and intention.

V Carfora, D Caso, M Conner

Appetite [117:152-160] (2017)

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The present study aimed to extend the literature on text messaging interventions involved in promoting healthy eating behaviours. The theoretical framework was the Theory of Planned Behaviour (TPB). A randomized controlled trial was used to test the impact of daily text messages compared to no message (groups) for reducing processed meat consumption (PMC) over a 2 week period, testing the sequential mediation role of anticipated regret and intention on the relationship between groups and PMC reduction. PMC and TPB variables were assessed both at Time 1 and Time 2. Participants were Italian undergraduates (at Time 1 N = 124) randomly allocated to control and message condition groups. Undergraduates in the message condition group received a daily SMS, which focused on anticipated regret and urged them to self-monitor PMC. Participants in the control group did not receive any message. Those who completed all measures at both time points were included in the analyses (N = 112). Findings showed that a daily messaging intervention, controlling for participants' past behaviour, reduced self-reported consumption of PMC. Mediation analyses indicated partial serial mediation via anticipated regret and intentions. The current study provided support for the efficacy of a daily messaging intervention targeting anticipated regret and encouraging self-monitoring in decreasing PMC. Outcomes showed the important mediating role of anticipated regret and intentions for reducing PMC.

 


Diet Behavior Change Techniques in Type 2 Diabetes: A Systematic Review and Meta-analysis.

Kevin Cradock, Gearóid ÓLaighin, Francis Finucane, Rhyann McKay, Leo Quinlan, Kathleen A Martin Ginis, Heather Gainforth

Diabetes care [40:1800-1810] (2017)

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Dietary behavior is closely connected to type 2 diabetes. The purpose of this meta-analysis was to identify behavior change techniques (BCTs) and specific components of dietary interventions for patients with type 2 diabetes associated with changes in HbA and body weight. The Cochrane Library, CINAHL, Embase, PubMed, PsycINFO, and Scopus databases were searched. Reports of randomized controlled trials published during 1975-2017 that focused on changing dietary behavior were selected, and methodological rigor, use of BCTs, and fidelity and intervention features were evaluated. In total, 54 studies were included, with 42 different BCTs applied and an average of 7 BCTs used per study. Four BCTs-"problem solving," "feedback on behavior," "adding objects to the environment," and "social comparison"-and the intervention feature "use of theory" were associated with >0.3% (3.3 mmol/mol) reduction in HbA. Meta-analysis revealed that studies that aimed to control or change the environment showed a greater reduction in HbA of 0.5% (5.5 mmol/mol) (95% CI -0.65, -0.34), compared with 0.32% (3.5 mmol/mol) (95% CI -0.40, -0.23) for studies that aimed to change behavior. Limitations of our study were the heterogeneity of dietary interventions and poor quality of reporting of BCTs. This study provides evidence that changing the dietary environment may have more of an effect on HbA in adults with type 2 diabetes than changing dietary behavior. Diet interventions achieved clinically significant reductions in HbA, although initial reductions in body weight diminished over time. If appropriate BCTs and theory are applied, dietary interventions may result in better glucose control.

 


Obesity reduction black intervention trial (ORBIT): six-month results.

Melinda Stolley, Marian Fitzgibbon, Linda Schiffer, Lisa Sharp, Vicky Singh, Linda Van Horn, Alan Dyer

Obesity (Silver Spring, Md.) [17:100-6] (2009)

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The Obesity Reduction Black Intervention Trial (ORBIT) is a randomized controlled trial designed to assess the efficacy of a culturally proficient 6-month weight loss intervention followed by a 1-year maintenance intervention. This article describes the results of the 6-month weight loss intervention. Two hundred thirteen obese black women aged 30-65 years were randomized to the intervention group or a general health control group. The intervention consisted of a 6-month culturally adapted weight loss program that targeted changes in diet and physical activity patterns. Weight, dietary intake, and physical activity were measured at baseline and 6 months. A total of 198 women (93%) completed both the baseline and postintervention assessments. Women in the intervention group lost significantly more weight than women in the control group (P < 0.001). However, weight change was variable within the intervention group, with a maximum weight loss of 19.4% of initial body weight and a maximum weight gain of 6.4% of initial body weight. Women in the intervention group also showed significant improvements in fruit intake (P < 0.01), Healthy Eating Index score (P < 0.001), and moderate (P = 0.05), and vigorous (P < 0.001) physical activity compared to women in the control group. This study demonstrates that a culturally adapted program can successfully promote weight loss in obese black women. However, average weight loss was relatively modest, and weight change varied widely within the intervention group. Further research is needed in order to develop programs that will allow more black women to achieve their weight loss goals..

 


Augmenting fruit and vegetable consumption by an online intervention: Psychological mechanisms.

Jan Keller, Susannah Motter, Mirjam Motter, Ralf Schwarzer

Appetite [120:348-355] (2018)

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Fruit and vegetable (FV) intake was examined among men and women who participated in an online intervention. The psychological constructs involved were outcome expectancies, behavioral intention, planning, and self-efficacy. One purpose of the analyses was the evaluation of a self-efficacy treatment component. The other purpose of the analyses regarded the role of psychological mechanisms that might be responsible for individual differences in the process of behavior change. A two-arm online intervention with a standard and an enhanced intervention group focusing on FV planning was conducted to improve FV intake, followed up at two and four weeks. The intervention groups differed by the additional inclusion of a self-efficacy ingredient in the enhanced intervention. Linear mixed models examined the intervention effects, and a longitudinal structural equation model explored which psychological constructs were associated with changes in FV intake. Participants were N = 275 adults of whom n = 148 completed the four-week follow-up. Their age range was 18-81 years (Mage = 32.50, SDage = 14.00). Analyses yielded an overall increase in self-reported FV intake. Moreover, a triple interaction between time, sex, and experimental groups on self-efficacy emerged, indicating that men, independent of treatment conditions, reported an increase in their confidence to improve FV intake, whereas women developed higher FV self-efficacy when being in the enhanced group instead of the standard group. Planning, self-efficacy, and intention mediated between outcome expectancies, and follow-up FV intake. Both intervention arms produced overall improvements in FV intake. The enhanced intervention resulted in a steeper increase in self-efficacy in women compared to men, and compared to the standard intervention. A psychological mechanism transpired that included a sequence leading from initial outcome expectancies via planning, self-efficacy, and intention towards FV intake.

 


The impact of an innovative web-based school nutrition intervention to increase fruits and vegetables and milk and alternatives in adolescents: a clustered randomized trial.

Karine Chamberland, Marina Sanchez, Shirin Panahi, Véronique Provencher, Jocelyn Gagnon, Vicky Drapeau

The international journal of behavioral nutrition and physical activity [14:140] (2017)

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The increase in overweight and obesity in adolescents and its health-related consequences highlight the need to develop strategies, which could help them adopt healthy eating habits. The objective of this study was to evaluate the impact of an innovative web-based school nutrition intervention (Team Nutriathlon) aimed at promoting the consumption of vegetables and fruit (V/F) and milk and alternatives (M/A) in high school students and to identify facilitators and/or barriers influencing its success. Ten classes of first and second year secondary students (grades 7 and 8) from the Québec City region were randomized into two groups (control n = 89 and intervention n = 193). Participants in the intervention (Team Nutriathlon) were to increase their consumption of V/F and M/A using an innovative web-based platform, developed for this study, over 6 weeks. The control group followed the regular school curriculum. The number of servings of V/F and M/A consumed by students per day was compared between the two groups before, during, immediately after and 10 weeks after the intervention using a web-based platform. Main outcome measures included V/F and M/A servings and facilitators and/or barriers of program success. Repeated measures linear fixed effects models were used to assess the impact of Team Nutriathlon on V/F and M/A consumption. A P-value of <0.05 was considered significant. Students in the intervention reported a significant increase of 3 servings and 1.8 servings per day of V/F and M/A, respectively, compared to the control group (P < 0.05); however, this was only observed in the short-term. Some factors contributing to the success of Team Nutriathlon included the team aspect of the program, use of the technology and recording results outside of classroom hours. Team Nutriathlon represents an innovative web-based nutrition program which positively impacts V/F and M/A consumption among high school students. Using web-based or technological platforms may help youth adopt healthy eating habits that will have implications later in adulthood; however, further studies are needed to determine their long-term effects. NCT03117374 (retrospectively registered).

 


Effects of a social cognitive theory-based hip fracture prevention web site for older adults.

Eun-Shim Nahm, Bausell Barker, Barbara Resnick, Barbara Covington, Jay Magaziner, Patricia Brennan

Computers, informatics, nursing : CIN [28:371-9] ()

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The purposes of this study were to develop a Social Cognitive Theory-based, structured Hip Fracture Prevention Web site for older adults and conduct a preliminary evaluation of its effectiveness. The Theory-based, structured Hip Fracture Prevention Web site is composed of learning modules and a moderated discussion board. A total of 245 older adults recruited from two Web sites and a newspaper advertisement were randomized into the Theory-based, structured Hip Fracture Prevention Web site and the conventional Web sites groups. Outcomes included (1) knowledge (hip fractures and osteoporosis), (2) self-efficacy and outcome expectations, and (3) calcium intake and exercise and were assessed at baseline, end of treatment (2 weeks), and follow-up (3 months). Both groups showed significant improvement in most outcomes. For calcium intake, only the Theory-based, structured Hip Fracture Prevention Web site group showed improvement. None of the group and time interactions were significant. The Theory-based, structured Hip Fracture Prevention Web site group, however, was more satisfied with the intervention. The discussion board usage was significantly correlated with outcome gains. Despite several limitations, the findings showed some preliminary effectiveness of Web-based health interventions for older adults and the use of a Theory-based, structured Hip Fracture Prevention Web site as a sustainable Web structure for online health behavior change interventions.

 


Long-term efficacy of a Web-based computer-tailored nutrition education intervention for adults including cognitive and environmental feedback: a randomized controlled trial.

Linda Springvloet, Lilian Lechner, Hein De Vries, Anke Oenema

BMC public health [15:372] (2015)

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Unhealthy diets are prevalent in Western countries, especially among low-educated people. To have an effect on health, it is important that dietary changes are sustained over time. This study examines long-term effects of a cognitive and environmental-feedback version of a Web-based computer-tailored (CT) nutrition education intervention targeting fruit, vegetables, high-energy snacks and saturated fat. A randomized controlled trial was conducted with a basic (tailored intervention targeting individual cognitions and self-regulation processes; n = 456), plus (additionally targeting environmental-level factors; n = 459) and control group (generic nutrition information; n = 434). Participants were recruited from the general population and randomly assigned to a study group. Online self-reported questionnaires assessed fruit, vegetable, high-energy snack and saturated fat intake, self-regulation, self-control, and Body Mass Index (BMI) at baseline and nine-months post-intervention. Linear mixed model analyses examined group differences in change over time. Educational differences were examined by 'group X time X education' interaction terms. Effects were examined in the total sample and among participants who did not comply with dietary- or BMI guidelines. The effects on vegetable intake in the total sample differed according to educational level (p = 02). Among low/moderate-educated participants, the basic version was significantly more effective in increasing vegetable intake than the control program (effect size (ES) = 0.32) and plus version (ES = 0.22). No effects were found for high-educated participants. Self-regulation change was significantly larger in the control group than in the basic (ES = 0.18) and plus (ES = 0.16) group. In general, both intervention versions did not result in long-term intervention effects. The exception was an effect of the basic version on self-reported vegetable intake among low/moderate-educated adults in the total sample. More research is needed on how targeting self-regulation processes and environmental-level factors in Web-based CT nutrition education interventions can increase long-term efficacy. Netherlands Trial Registry NTR3396 .

 


Using aversive images to enhance healthy food choices and implicit attitudes: An experimental test of evaluative conditioning.

Gareth Hollands, Andrew Prestwich, Theresa Marteau

Health psychology : official journal of the Division of Health Psychology, American Psychological Association [30:195-203] (2011)

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To examine the effect of communicating images of energy-dense snack foods paired with aversive images of the potential health consequences of unhealthy eating, on implicit and explicit attitudes and food choice behavior. Participants were randomly allocated to either an evaluative conditioning (EC) procedure that paired images of snack foods with images of potential adverse health consequences or a control condition that featured images of snack foods alone. Implicit attitudes were assessed pre- and post-intervention. Explicit attitudes and food choice behavior were assessed post-intervention. The conditioning intervention made implicit attitudes toward energy-dense snacks more negative, with this effect greatest in those with relatively more favorable implicit attitudes toward these snacks at baseline. Participants in the conditioning intervention were more likely to choose fruit rather than snacks in a behavioral choice task, a relationship mediated by changes in implicit attitudes. Presenting aversive images of potential health consequences with those of specific foodstuffs can change implicit attitudes, which impacts on subsequent food choice behavior.

 


Mechanisms of change of a novel weight loss programme provided by a third sector organisation: a qualitative interview study.

Naoimh McMahon, Shelina Visram, Louise Connell

BMC public health [16:378] (2016)

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There is a need for theory-driven studies that explore the underlying mechanisms of change of complex weight loss programmes. Such studies will contribute to the existing evidence-base on how these programmes work and thus inform the future development and evaluation of tailored, effective interventions to tackle overweight and obesity. This study explored the mechanisms by which a novel weight loss programme triggered change amongst participants. The programme, delivered by a third sector organisation, addressed both diet and physical activity. Over a 26 week period participants engaged in three weekly sessions (education and exercise in a large group, exercise in a small group and a one-to-one education and exercise session). Novel aspects included the intensity and duration of the programme, a competitive selection process, milestone physical challenges (e.g. working up to a 5 K and 10 K walk/run during the programme), alumni support (face-to-face and online) and family attendance at exercise sessions. Data were collected through interviews with programme providers (n = 2) and focus groups with participants (n = 12). Discussions were audio-recorded, transcribed and analysed using NVivo10. Published behaviour change frameworks and behaviour change technique taxonomies were used to guide the coding process. Clients' interactions with components of the weight loss programme brought about a change in their commitment, knowledge, beliefs about capabilities and social and environmental contexts. Intervention components that generated these changes included the competitive selection process, group and online support, family involvement and overcoming milestone challenges over the 26 week programme. The mechanisms by which these components triggered change differed between participants. There is an urgent need to establish robust interventions that can support people who are overweight and obese to achieve a healthy weight and maintain this change. Third sector organisations may be a feasible alternative to private and public sector weight loss programmes. We have presented findings from one example of a novel community-based weight loss programme and identified how the programme components resulted in change amongst the participants. Further research is needed to robustly test the effectiveness, and cost-effectiveness, of this programme.

 


Planning and self-efficacy interventions encouraging replacing energy-dense foods intake with fruit and vegetable: A longitudinal experimental study.

Aleksandra Luszczynska, Karolina Horodyska, Karolina Zarychta, Natalia Liszewska, Nina Knoll, Urte Scholz

Psychology & health [31:40-64] (2016)

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This longitudinal experimental study compared effects of self-efficacy, planning and education-based conditions, encouraging adolescents to eat fruit and vegetable in place of energy-dense foods. Data were collected among 506 adolescents (13-18 years old) who were randomly assigned to control (n = 181), planning (n = 153) or self-efficacy (n = 172) conditions. Measurements were taken at baseline (T1), at a 2-month follow-up (T2), and at a 14-month follow-up (T3). Interventions/control group procedures were delivered at T1 and T2. Self-reports of fruit and vegetable intake (FVI) and energy-dense foods intake were collected at three times. Cognitive mediators (self-efficacy and planning) were assessed at T1 and T2. Body weight and height were objectively measured at T1 and T3. Similar significant increases of FVI were found for planning and self-efficacy interventions (T3). The planning intervention did not influence energy-dense food intake (T3), but the self-efficacy intervention tended to result in stabilising intake (compared to an increase found in the control group). There were no effects on body weight. Similar patterns were found for the total sample and for a subsample of adolescents with overweight/obesity. The effects of interventions on FVI were mediated by respective cognitions.

 



Brief fruit and vegetable messages integrated within a community physical activity program successfully change behaviour.

Shawna Doerksen, Paul Estabrooks

The international journal of behavioral nutrition and physical activity [4:12] (2007)

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Consumption of the recommended amounts of fruits and vegetables is associated with several health benefits. Currently less than 25% of the American population meets the minimum recommendation of five servings a day. In order to change this health behaviour, interventions should be based on theory and include community-wide social support. A low intensity intervention was developed in which participants (n = 86) were randomly assigned to either the fruit and vegetable intervention (FVI) or standard control condition. The intervention was integrated into an ongoing community physical activity program and study participants were drawn from the sample of community members enrolled in the program. The FVI consisted of brief social cognitive theory-based messages delivered in nine weekly newsletters designed to improve participant outcome and self-efficacy expectations related to fruit and vegetable consumption. Participants in the FVI condition increased in their fruit and vegetable consumption by approximately one to one and one-third servings per day. The control condition showed no change in consumption. The effect of the intervention was enhanced when examined by the extent to which it was adopted by participants (i.e., the number of newsletters read). Those participants who read seven or more newsletters showed an increase of two servings per day. This intervention was effective at improving fruit and vegetable consumption among adults. Minimal interventions, such as newsletters, have the ability to reach large audiences and can be integrated into ongoing health promotion programs. As such, they have potential for a strong public health impact.

 


Short-term efficacy of a web-based computer-tailored nutrition intervention: main effects and mediators.

A Oenema, F Tan, J Brug

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine [29:54-63] (2005)

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This study evaluates the short-term efficacy and respondents' evaluations of a Web-based computer-tailored nutrition intervention, aiming to decrease saturated fat intake and increase fruit and vegetable intake. Perceived personal relevance, individualization, and interestingness of the information were tested as mediators of the effects of the tailored intervention. The objective was to study the short-term effects of a Web-based computer-tailored nutrition intervention. Respondents (N = 782) were randomly assigned to a tailored intervention group, a generic nutrition information control group, or a no-information control group. Fat, fruit, and vegetable intakes and behavioral determinants were measured at baseline and at 3 weeks postintervention. Posttest group differences were determined by multiple linear regression analyses. The computer-tailored intervention produced significant effects for the determinants of fat, fruit, and vegetable intake and for vegetable and fruit intake. The tailored information was rated as more personally relevant, individualized, interesting, and new than the generic nutrition information. Perceived personal relevance, individualization, and interestingness were identified as mediators of some of the tailoring effects. The findings of this study indicate that Web-based, computer-tailored nutrition information can have a short-term effect on the determinants of fat, fruit, and vegetable intake. The effect of the tailored information may be partly explained by the perceived personal relevance and individualization of the information.

 


Can existing mobile apps support healthier food purchasing behaviour? Content analysis of nutrition content, behaviour change theory and user quality integration.

Sarah-Jane Flaherty, Mary McCarthy, Alan Collins, Fionnuala McAuliffe

Public health nutrition [21:288-298] (2018)

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To assess the quality of nutrition content and the integration of user quality components and behaviour change theory relevant to food purchasing behaviour in a sample of existing mobile apps. Descriptive comparative analysis of eleven mobile apps comprising an assessment of their alignment with existing evidence on nutrition, behaviour change and user quality, and their potential ability to support healthier food purchasing behaviour. Mobile apps freely available for public use in GoogePlay were assessed and scored according to agreed criteria to assess nutrition content quality and integration of behaviour change theory and user quality components. A sample of eleven mobile apps that met predefined inclusion criteria to ensure relevance and good quality. The quality of the nutrition content varied. Improvements to the accuracy and appropriateness of nutrition content are needed to ensure mobile apps support a healthy behaviour change process and are accessible to a wider population. There appears to be a narrow focus towards behaviour change with an overemphasis on behavioural outcomes and a small number of behaviour change techniques, which may limit effectiveness. A significant effort from the user was required to use the mobile apps appropriately which may negatively influence user acceptability and subsequent utilisation. Existing mobile apps may offer a potentially effective approach to supporting healthier food purchasing behaviour but improvements in mobile app design are required to maximise their potential effectiveness. Engagement of mobile app users and nutrition professionals is recommended to support effective design.

 


Increasing intention to cook from basic ingredients: A randomised controlled study.

Fiona Lavelle, Lynsey Hollywood, Martin Caraher, Laura McGowan, Michelle Spence, Dawn Surgenor, Amanda McCloat, Elaine Mooney, Monique Raats, Moira Dean

Appetite [116:502-510] (2017)

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The promotion of home cooking is a strategy used to improve diet quality and health. However, modern home cooking typically includes the use of processed food which can lead to negative outcomes including weight gain. In addition, interventions to improve cooking skills do not always explain how theory informed their design and implementation. The Behaviour Change Technique (BCT) taxonomy successfully employed in other areas has identified essential elements for interventions. This study investigated the effectiveness of different instructional modes for learning to cook a meal, designed using an accumulating number of BCTs, on participant's perceived difficulty, enjoyment, confidence and intention to cook from basic ingredients. 141 mothers aged between 20 and 39 years from the island of Ireland were randomised to one of four conditions based on BCTs (1) recipe card only [control condition]; (2) recipe card plus video modelling; (3) recipe card plus video prompting; (4) recipe card plus video elements. Participants rated their enjoyment, perceived difficulty, confidence and intention to cook again pre, mid and post experiment. Repeated one-way factorial ANOVAs, correlations and a hierarchical regression model were conducted. Despite no significant differences between the different conditions, there was a significant increase in enjoyment (P < 0.001), confidence (P < 0.001) and intention to cook from basics again (P < 0.001) and a decrease in perceived difficulty (P = 0.001) after the experiment in all conditions. Intention to cook from basics pre-experiment, and confidence and enjoyment (both pre and post experiment) significantly contributed to the final regression model explaining 42% of the variance in intention to cook from basics again. Cooking interventions should focus on practical cooking and increasing participants' enjoyment and confidence during cooking to increase intention to cook from basic ingredients at home.

 


Pounds Off Digitally study: a randomized podcasting weight-loss intervention.

Gabrielle Turner-McGrievy, Marci Campbell, Deborah Tate, Kimberly Truesdale, J Michael Bowling, Lelia Crosby

American journal of preventive medicine [37:263-9] (2009)

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As obesity rates rise, new weight-loss methods are needed. Little is known about the use of podcasting (audio files for a portable music player or computer) to promote weight loss, despite its growing popularity. A 12-week RCT was conducted. The study sample comprised overweight men and women (BMI=25-40 kg/m(2); n=78) in the Raleigh-Durham NC area. In 2008, participants were randomly assigned to receive 24 episodes of a currently available weight-loss podcast (control podcast) or a weight-loss podcast based on social cognitive theory (SCT) designed by the researchers (enhanced podcast) for 12 weeks. Weight was measured on a digital scale at baseline and follow-up. Both groups also completed questionnaires assessing demographic information, food intake, physical activity, and SCT constructs at the introductory and 12-week meetings. Additional questionnaires at the 12-week meeting assessed perceptions of the intervention. Data collection and analysis occurred in 2008 and intention-to-treat was used. Enhanced group participants (n=41) had a greater decrease in weight (-2.9+/-3.5 kg enhanced group vs -0.3+/-2.1 control group; p<0.001 between groups) and BMI (-1.0+/-1.2 kg/m(2) enhanced group vs -0.1+/-0.7 kg/m(2) control group; p<0.001 between groups) than the control group (n=37) and had greater weight-loss-related knowledge (p<0.05), elaboration (p<0.001), and user control (p<0.001) and less cognitive load (p<0.001). The results of this study suggest that the use of behavioral, theory-based podcasting may be an effective way to promote weight loss. NCT00771095.

 


How can self-efficacy be increased? Meta-analysis of dietary interventions.

Andrew Prestwich, Ian Kellar, Richard Parker, Siobhan MacRae, Matthew Learmonth, Bianca Sykes, Natalie Taylor, Holly Castle

Health psychology review [8:270-85] (2014)

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Targeting individuals' beliefs that they are able to eat healthily can improve dietary-related behaviours. However, the most effective behaviour change techniques (BCTs) to promote dietary self-efficacy have not been systematically reviewed. This research addressed this gap. Studies testing the effect of interventions on healthy eating and underlying dietary-related self-efficacy, within randomised controlled trials, were systematically reviewed in MEDLINE, EMBASE and PSYCINFO. Two reviewers independently coded intervention content in both intervention and comparison groups. Data pertaining to study quality were also extracted. Random effects meta-analysis was used to calculate an overall effect size on dietary self-efficacy for each study. The associations between 26 BCTs and self-efficacy effects were calculated using meta-regression. In some of the analyses, interventions that incorporated self-monitoring (tracking one's own food-related behaviour), provided feedback on performance, prompted review of behavioural goals, provided contingent rewards (rewarding diet success), or planned for social support/social change increased dietary self-efficacy significantly more than interventions that did not. Stress management was consistently associated with self-efficacy effects across all analyses. There was strong evidence for stress management and weaker evidence for a number of other BCTs. The findings can be used to develop more effective, theory- and evidence-based behavioural interventions.

 


A brief intervention increases fruit and vegetable intake. A comparison of two intervention sequences.

Pempa Lhakhang, Cristina Godinho, Nina Knoll, Ralf Schwarzer

Appetite [82:103-10] (2014)

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To evaluate the effectiveness of two subsequent intervention components (motivational and self-regulatory components), placed in different order, to promote fruit and vegetable (FV) intake. After baseline assessment, university students (N=205, aged 18-26 years) were allocated to two groups. One group received a motivational intervention (outcome expectancies, risk perception, and task self-efficacy) followed by a self-regulatory intervention (planning and dietary self-efficacy) after 17 days. The second group received the same intervention conditions in the opposite order. Follow-up assessments were done after another 17 days. Both intervention sequences yielded gains in terms of FV intake and self-efficacy. However, this gain was only due to the self-regulatory component whereas the motivational component did not contribute to the changes. Moreover, changes in intention and self-efficacy mediated between intervention sequence and follow-up behavior, suggesting that improving these proximal predictors of FV intake was responsible for the behavioral gains. Findings highlight the superiority of a self-regulatory intervention over a motivational intervention when it comes to dietary changes in this sample of young adults. Moreover, changes in dietary self-efficacy may drive nutritional changes.

 


Evaluating a small change approach to preventing long term weight gain in overweight and obese adults--Study rationale, design, and methods.

Robert Ross, James Hill, Amy Latimer, Andrew Day

Contemporary clinical trials [47:275-81] (2016)

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Despite the rapid rise in obesity worldwide, few strategies have been effective in treating this epidemic. An emerging strategy is to focus on preventing excessive weight gain rather than weight reduction. The proposed intervention, small change approach (SCA), is an innovative weight gain prevention strategy in which individuals monitor their usual nutrition and physical activity patterns and then make modest but sustainable alterations through behavioral intervention techniques (self-regulation, goal setting) enough to reduce overall energy balance by 100 to 200 kcal per day (e.g., reduce caloric intake by 100 kcal per day and/or increase daily step count by ~2000 steps (~100 kcal) per day). The primary aim of the trial is to determine whether small changes in energy expenditure and/or energy intake prevent weight gain in overweight and obese men and women long-term. The pre-specified primary and secondary assessments are at 2 and 3 years post-randomization respectively. The primary outcome is change in body weight. Secondary outcomes include body composition variables (adipose tissue distribution and lean mass distribution) and cardiorespiratory fitness (VO2peak). We randomized 320 primarily White (n=305) overweight and obese men and women to one of 2 conditions: 1) usual care (UC), 2) small change approach (SCA). Participant involvement in the study is 3 years; 2 year intervention with a 1 year follow-up. Our study findings will indicate whether there is value in clinicians adopting a SCA to lifestyle counseling for their patients who are overweight and obese.

 


Iterative development of Vegethon: a theory-based mobile app intervention to increase vegetable consumption.

Sarah Mummah, Abby King, Christopher Gardner, Stephen Sutton

The international journal of behavioral nutrition and physical activity [13:90] (2016)

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Mobile technology may serve as a cost-effective and scalable tool for delivering behavioral nutrition interventions. This research sought to iteratively develop a theory-driven mobile app, Vegethon, to increase vegetable consumption. Development of Vegethon followed phases outlined by the IDEAS framework: 1) empathize with users (qualitative interviews, n = 18); 2) specify target behavior; 3) ground in behavioral theory; 4) ideate implementation strategies; 5) prototype potential products; 6) gather user feedback (qualitative interviews, n = 14; questionnaire, n = 41); 7) build minimum viable product; and 8) pilot potential efficacy and usability (pilot RCT, n = 17). Findings from each phase informed subsequent phases. The target population that informed intervention development was 18-50 years of age, had BMIs of 28-40 kg/m(2), and lived in the geographical area surrounding Stanford University. A full description of the final version of Vegethon is included in the paper. Qualitative findings that shaped initial intervention conception were: participants' interests in accountability without judgment; their desire for simple and efficient dietary self-monitoring; and the importance of planning meals in advance. Qualitative findings identified during intervention refinement were the need for a focus on vegetable self-monitoring; inclusion of vegetable challenges; simplification of features; advice and inspiration for eating vegetables; reminder notifications; and peer comparison. Pilot RCT findings suggested the initial efficacy, acceptance, and feasibility of the intervention. The final version of Vegethon enabled easy self-monitoring of vegetable consumption and included a range of features designed to engage the user (e.g., surprise challenges; leaderboard; weekly reports). Vegethon was coded for its inclusion of 18 behavior change techniques (BCTs) (e.g., goal setting; feedback; social comparison; prompts/cues; framing/reframing; identity). Vegethon is a theory-based, user-informed mobile intervention that was systematically developed using the IDEAS framework. Vegethon targets increased vegetable consumption among overweight adults and is currently being evaluated in a randomized controlled efficacy trial. Clinical Trials.gov: NCT01826591.

 


Design of a Mobile App for Nutrition Education (TreC-LifeStyle) and Formative Evaluation With Families of Overweight Children.

Silvia Gabrielli, Marco Dianti, Rosa Maimone, Marta Betta, Lorena Filippi, Monica Ghezzi, Stefano Forti

JMIR mHealth and uHealth [5:e48] (2017)

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Nutrition and diet apps represent today a popular area of mobile health (mHealth), offering the possibility of delivering behavior change (BC) interventions for healthy eating and weight management in a scalable and cost-effective way. However, if commercial apps for pediatric weight management fail to retain users because of a lack of theoretical background and evidence-based content, mHealth apps that are more evidence-based are found less engaging and popular among consumers. Approaching the apps development process from a multidisciplinary and user-centered design (UCD) perspective is likely to help overcome these limitations, raising the chances for an easier adoption and integration of nutrition education apps within primary care interventions. The aim of this study was to describe the design and development of the TreC-LifeStyle nutrition education app and the results of a formative evaluation with families. The design of the nutrition education intervention was based on a multidisciplinary UCD approach, involving a team of BC experts, working with 2 nutritionists and 3 pediatricians from a primary care center. The app content was derived from evidence-based knowledge founded on the Food Pyramid and Mediterranean Diet guidelines used by pediatricians in primary care. A formative evaluation of the TreC-LifeStyle app involved 6 families of overweight children (aged 7-12 years) self-reporting daily food intake of children for 6 weeks and providing feedback on the user experience with the mHealth intervention. Analysis of the app's usage patterns during the intervention and of participants' feedback informed the refinement of the app design and a tuning of the nutrition education strategies to improve user engagement and compliance with the intervention. Design sessions with the contribution of pediatricians and nutritionists helped define the nutrition education app and intervention, providing an effective human and virtual coaching approach to raise parents' awareness about children's eating behavior and lifestyle. The 6 families participating in the pilot study found the app usable and showed high compliance with the intervention over the 6 weeks, but analysis of their interaction and feedback showed the need for improving some of the app features related to the BC techniques "monitoring of the behavior" and "information provision." The UCD and formative evaluation of TreC-LifeStyle show that nutrition education apps are feasible and acceptable solutions to support health promotion interventions in primary care.

 


Impact of a male-only weight loss maintenance programme on social-cognitive determinants of physical activity and healthy eating: A randomized controlled trial.

Myles Young, Ronald Plotnikoff, Clare Collins, Robin Callister, Philip Morgan

British journal of health psychology [20:724-44] (2015)

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To examine the effect of a gender-tailored, Social Cognitive Theory (SCT)-based weight loss maintenance (WLM) intervention on men's physical activity and healthy eating cognitions and behaviours in the 12 months after completing a weight loss programme. A two-phase, assessor-blinded, randomized controlled trial. Ninety-two overweight/obese men (mean [SD] age: 49.2 years [10.1], BMI: 30.7 [3.3] kg/m(2) ) who lost at least 4 kg after completing the 3-month SCT-based SHED-IT Weight Loss Program were randomly allocated to receive (1) the SCT-based SHED-IT WLM Program; or (2) no additional resources (self-help control group). The 6-month gender-tailored SHED-IT WLM Program was completely self-administered and operationalized SCT behaviour change principles to assist men to increase moderate-to-vigorous physical activity (MVPA) and decrease energy-dense, nutrient-poor (discretionary) food consumption after initial weight loss. After randomization (WLM baseline), men were reassessed at 6 months (WLM post-test) and 12 months (6-month WLM follow-up). SCT cognitions (e.g., self-efficacy, goal setting), MVPA, and discretionary food consumption were assessed with validated measures. Following significant improvements in cognitions, MVPA and discretionary food consumption during the weight loss phase, intention-to-treat, linear mixed models revealed no significant group-by-time differences in cognitions or behaviours during the WLM phase. Initial improvements in MVPA and some cognitions (e.g., goal setting, planning, and social support) were largely maintained by both groups at the end of the study. Dietary effects were not as strongly maintained, with the intervention and control groups maintaining 57% and 75% of the Phase I improvements in discretionary food intake, respectively. An additional SCT-based WLM programme did not elicit further improvements over a self-help control in the cognitions or behaviours for MVPA or discretionary food intake of men who had lost weight with a SCT-based weight loss programme. Statement of contribution What is already known on this subject?Weight regain after weight loss (WL) is common. As successful weight loss maintenance (WLM) requires sustained improvements in cognitions and behaviours, health psychology can contribute to intervention development. However, little research has examined the utility of psychological theory in the context of a WLM randomised controlled trial. What does this study add? A theory-based WL program improved men's physical activity and dietary behaviours and cognitions. Men who also received a theory-based WLM program did not show further improvements in physical activity or dietary cognitions and behaviours compared to those that did not.

 


Effectiveness of brief nutrition interventions on dietary behaviours in adults: A systematic review.

Megan Whatnall, Amanda Patterson, Lee Ashton, Melinda Hutchesson

Appetite [120:335-347] (2018)

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Brief interventions are effective in improving health behaviours including alcohol intake, however the effectiveness of brief interventions targeting nutrition outcomes has not been determined. The aim of this systematic review was to determine the effectiveness of brief nutrition interventions in adults. Seven databases were searched for RCT/pseudo RCT studies published in English to April 2016, and evaluating brief interventions (i.e. single point of contact) designed to promote change in eating behaviours in healthy adults (≥18 years). Of 4849 articles identified, 45 studies met inclusion criteria. Most studies targeted fruit and/or vegetable intake (n = 21) or fat intake (n = 10), and few targeted diet quality (n = 2). Median follow-up was 3.5 months, with few studies (n = 4) measuring longer-term outcomes (≥12 months). Studies aimed to determine whether a brief intervention was more effective than another brief intervention (n = 30), and/or more effective than no intervention (n = 20), with 17 and 11 studies, respectively, reporting findings to that effect. Interventions providing education plus tailored or instructional components (e.g. feedback) were more effective than education alone or non-tailored advice. This review suggests that brief interventions, which are tailored and instructional, can improve short-term dietary behaviours, however evidence for longer-term behaviour change maintenance is limited.

 



Application of Intervention Mapping to develop a community-based health promotion pre-pregnancy intervention for adolescent girls in rural South Africa: Project Ntshembo (Hope).

Catherine Draper, Lisa Micklesfield, Kathleen Kahn, Stephen Tollman, John Pettifor, David Dunger, Shane Norris

BMC public health [14 Suppl 2:S5] (2014)

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South Africa (SA) is undergoing multiple transitions with an increasing burden of non-communicable diseases and high levels of overweight and obesity in adolescent girls and women. Adolescence is key to addressing trans-generational risk and a window of opportunity to intervene and positively impact on individuals' health trajectories into adulthood. Using Intervention Mapping (IM), this paper describes the development of the Ntshembo intervention, which is intended to improve the health and well-being of adolescent girls in order to limit the inter-generational transfer of risk of metabolic disease, in particular diabetes risk. This paper describes the application of the first four steps of IM. Evidence is provided to support the selection of four key behavioural objectives: viz. to eat a healthy, balanced diet, increase physical activity, reduce sedentary behaviour, and promote reproductive health. Appropriate behaviour change techniques are suggested and a theoretical framework outlining components of relevant behaviour change theories is presented. It is proposed that the Ntshembo intervention will be community-based, including specialist adolescent community health workers who will deliver a complex intervention comprising of individual, peer, family and community mobilisation components. The Ntshembo intervention is novel, both in SA and globally, as it is: (1) based on strong evidence, extensive formative work and best practice from evaluated interventions; (2) combines theory with evidence to inform intervention components; (3) includes multiple domains of influence (community through to the individual); (4) focuses on an at-risk target group; and (5) embeds within existing and planned health service priorities in SA.

 


Maternal Obesity Management Using Mobile Technology: A Feasibility Study to Evaluate a Text Messaging Based Complex Intervention during Pregnancy.

Hora Soltani, Alexandra Duxbury, Madelynne Arden, Andy Dearden, Penny Furness, Carolyn Garland

Journal of obesity [2015:814830] (2015)

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Maternal obesity and excessive gestational weight gain (GWG) are on the rise with negative impact on pregnancy and birth outcomes. Research into managing GWG using accessible technology is limited. The maternal obesity management using mobile technology (MOMTech) study aimed at evaluating the feasibility of text messaging based complex intervention designed to support obese women (BMI ≥ 30) with healthier lifestyles and limit GWG. Participants received two daily text messages, supported by four appointments with healthy lifestyle midwife, diet and activity goal setting, and self-monitoring diaries. The comparison group were obese mothers who declined to participate but consented for their routinely collected data to be used for comparison. Postnatal interviews and focus groups with participants and the comparison group explored the intervention's acceptability and suggested improvements. Fourteen women completed the study which did not allow statistical analyses. However, participants had lower mean GWG than the comparison group (6.65 kg versus 9.74 kg) and few (28% versus 50%) exceeded the Institute of Medicine's upper limit of 9 kg GWG for obese women. MOMTech was feasible within clinical setting and acceptable intervention to support women to limit GWG. Before further trials, slight modifications are planned to recruitment, text messages, and the logistics of consultation visits.

 


Nutrition self-efficacy is unidirectionally related to outcome expectations in children.

Andrew Larsen, John McArdle, Trina Robertson, Genevieve Dunton

Appetite [84:166-70] (2015)

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To clarify the underlying relationship between nutrition self-efficacy and outcome expectations because the direction of the relationship (unidirectional vs bidirectional) is debated in the literature. Secondary data analysis of a 10-week, 10-lesson school-based nutrition education intervention among 3rd grade students (N  =  952). Nutrition self-efficacy (7 items) and nutrition outcome expectations (9 items) were measured through student self-report at intervention pre- (time 1) and post- (time 2) assessments. A series of two time point, multi-group cross-lagged bivariate change score models were used to determine the direction of the relationship. A cross lag from nutrition self-efficacy at time 1 predicting changes in nutrition outcome expectations at time 2 significantly improved the fit of the model (Model 3), whereas a cross lag from nutrition outcome expectations at time 1 to changes in nutrition self-efficacy at time 2 only slightly improved the fit of the model (Model 2). Furthermore, adding both cross lags (Model 4) did not improve model fit compared to the model with only the self-efficacy cross lag (Model 3). Lastly, the nutrition outcome expectations cross lag did not significantly predict changes in nutrition self-efficacy in any of the models. Data suggest that there is a unidirectional relationship between nutrition self-efficacy and outcome expectations, in which self-efficacy predicts outcome expectations. Therefore, theory-based nutrition interventions may consider focusing more resources on changing self-efficacy because it may also lead to changes in outcome expectations as well.

 


Effects of a tailored health promotion program for female blue-collar workers: health works for women.

Marci Campbell, Irene Tessaro, Brenda DeVellis, Salli Benedict, Kristine Kelsey, Leigh Belton, Antonio Sanhueza

Preventive medicine [34:313-23] (2002)

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This study assessed the effects of the Health Works for Women (HWW) intervention on improving multiple behaviors including nutrition and physical activity among rural female blue-collar employees in North Carolina. Nine small to mid-size workplaces were randomly assigned to either intervention or delayed intervention conditions. After a baseline survey, an intervention consisting of two computer-tailored magazines and a natural helpers program was conducted over 18 months. Delayed worksites received one tailored magazine. Approximately 77 and 76% of baseline respondents completed follow-up surveys at 6 and 18 months, respectively, and 538 women (63%) completed all three surveys. At the 18-month follow-up, the intervention group had increased fruit and vegetable consumption by 0.7 daily servings compared to no change in the delayed group (P < 0.05). Significant differences in fat intake were observed at 6 months (P < 0.05) but not at 18 months. The intervention group also demonstrated improvements in strengthening and flexibility exercise compared to the delayed group. The rates of smoking cessation and cancer screening did not differ between study groups. The HWW project was a successful model for achieving certain health behavior changes among blue-collar women.

 


Provision of social norm feedback to high prescribers of antibiotics in general practice: a pragmatic national randomised controlled trial.

Michael Hallsworth, Tim Chadborn, Anna Sallis, Michael Sanders, Daniel Berry, Felix Greaves, Lara Clements, Sally Davies

Lancet (London, England) [387:1743-52] (2016)

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Unnecessary antibiotic prescribing contributes to antimicrobial resistance. In this trial, we aimed to reduce unnecessary prescriptions of antibiotics by general practitioners (GPs) in England. In this randomised, 2 × 2 factorial trial, publicly available databases were used to identify GP practices whose prescribing rate for antibiotics was in the top 20% for their National Health Service (NHS) Local Area Team. Eligible practices were randomly assigned (1:1) into two groups by computer-generated allocation sequence, stratified by NHS Local Area Team. Participants, but not investigators, were blinded to group assignment. On Sept 29, 2014, every GP in the feedback intervention group was sent a letter from England's Chief Medical Officer and a leaflet on antibiotics for use with patients. The letter stated that the practice was prescribing antibiotics at a higher rate than 80% of practices in its NHS Local Area Team. GPs in the control group received no communication. The sample was re-randomised into two groups, and in December, 2014, GP practices were either sent patient-focused information that promoted reduced use of antibiotics or received no communication. The primary outcome measure was the rate of antibiotic items dispensed per 1000 weighted population, controlling for past prescribing. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN32349954, and has been completed. Between Sept 8 and Sept 26, 2014, we recruited and assigned 1581 GP practices to feedback intervention (n=791) or control (n=790) groups. Letters were sent to 3227 GPs in the intervention group. Between October, 2014, and March, 2015, the rate of antibiotic items dispensed per 1000 population was 126.98 (95% CI 125.68-128.27) in the feedback intervention group and 131.25 (130.33-132.16) in the control group, a difference of 4.27 (3.3%; incidence rate ratio [IRR] 0.967 [95% CI 0.957-0.977]; p<0.0001), representing an estimated 73,406 fewer antibiotic items dispensed. In December, 2014, GP practices were re-assigned to patient-focused intervention (n=777) or control (n=804) groups. The patient-focused intervention did not significantly affect the primary outcome measure between December, 2014, and March, 2015 (antibiotic items dispensed per 1000 population: 135.00 [95% CI 133.77-136.22] in the patient-focused intervention group and 133.98 [133.06-134.90] in the control group; IRR for difference between groups 1.01, 95% CI 1.00-1.02; p=0.105). Social norm feedback from a high-profile messenger can substantially reduce antibiotic prescribing at low cost and at national scale; this outcome makes it a worthwhile addition to antimicrobial stewardship programmes. Public Health England.

 


Development of a Theory-Based Intervention to Increase Clinical Measurement of Reactive Balance in Adults at Risk of Falls.

Kathryn Sibley, Dina Brooks, Paula Gardner, Tania Janaudis-Ferreira, Mandy McGlynn, Sachi OʼHoski, Sara McEwen, Nancy Salbach, Jennifer Shaffer, Paula Shing, Sharon Straus, Susan Jaglal

Journal of neurologic physical therapy : JNPT [40:100-6] (2016)

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Effective balance reactions are essential for avoiding falls, but are not regularly measured by physical therapists. Physical therapists report wanting to improve reactive balance assessment, and theory-based approaches are recommended as the foundation for the development of interventions. This article describes how a behavior change theory for health care providers, the theoretical domains framework (TDF), was used to develop an intervention to increase reactive balance measurement among physical therapists who work in rehabilitation settings and treat adults who are at risk of falls. We employed published recommendations for using the TDF-guided intervention development. We identified what health care provider behavior is in need of change, relevant barriers and facilitators, strategies to address them, and how we would measure behavior change. In this case, identifying strategies required selecting both a reactive balance measure and behavior change techniques. Previous research had determined that physical therapists need to increase reactive balance measurement, and identified barriers and facilitators that corresponded to 8 TDF domains. A published review informed the selection of the Balance Evaluation Systems Test (Reactive Postural Responses Section) as addressing the barriers and facilitators, and existing research informed the selection of 9 established behavior change techniques corresponding to each identified TDF domain. The TDF framework were incorporated into a 12-month intervention with interactive group sessions, local champions, and health record modifications. Intervention effect can be evaluated using health record abstraction, questionnaires, and qualitative semistructured interviews. Although future research will evaluate the intervention in a controlled study, the process of theory-based intervention development can be applied to other rehabilitation research contexts, maximizing the impact of this work.Video Abstract is available for more insights from the authors (see Supplemental Digital Content 1, http://links.lww.com/JNPT/A123).

 


Characterising an implementation intervention in terms of behaviour change techniques and theory: the 'Sepsis Six' clinical care bundle.

Siri Steinmo, Christopher Fuller, Sheldon Stone, Susan Michie

Implementation science : IS [10:111] (2015)

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Sepsis is a major cause of death from infection, with a mortality rate of 36 %. This can be halved by implementing the 'Sepsis Six' evidence-based care bundle within 1 h of presentation. A UK audit has shown that median implementation rates are 27-47 % and interventions to improve this have demonstrated minimal effects. In order to develop more effective implementation interventions, it is helpful to obtain detailed characterisations of current interventions and to draw on behavioural theory to identify mechanisms of change. The aim of this study was to illustrate this process by using the Behaviour Change Wheel; Behaviour Change Technique (BCT) Taxonomy; Capability, Opportunity, Motivation model of behaviour; and Theoretical Domains Framework to characterise the content and theoretical mechanisms of action of an existing intervention to implement Sepsis Six. Data came from documentary, interview and observational analyses of intervention delivery in several wards of a UK hospital. A broad description of the intervention was created using the Template for Intervention Description and Replication framework. Content was specified in terms of (i) component BCTs using the BCT Taxonomy and (ii) intervention functions using the Behaviour Change Wheel. Mechanisms of action were specified using the Capability, Opportunity, Motivation model and the Theoretical Domains Framework. The intervention consisted of 19 BCTs, with eight identified using all three data sources. The BCTs were delivered via seven functions of the Behaviour Change Wheel, with four ('education', 'enablement', 'training' and 'environmental restructuring') supported by the three data sources. The most frequent mechanisms of action were reflective motivation (especially 'beliefs about consequences' and 'beliefs about capabilities') and psychological capability (especially 'knowledge'). The intervention consisted of a wide range of BCTs targeting a wide range of mechanisms of action. This study demonstrates the utility of the Behaviour Change Wheel, the BCT Taxonomy and the Theoretical Domains Framework, tools recognised for providing guidance for intervention design, for characterising an existing intervention to implement evidence-based care.

 


Strengthening the role and functions of nursing staff in inpatient stroke rehabilitation: developing a complex intervention using the Behaviour Change Wheel.

Mia Ingerslev Loft, Bente Martinsen, Bente Appel Esbensen, Lone Mathiesen, Helle Iversen, Ingrid Poulsen

International journal of qualitative studies on health and well-being [12:1392218] (2017)

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Over the past two decades, attempts have been made to describe the nurse's role and functions in the inpatient stroke rehabilitation; however, the nursing contribution is neither clear nor well-defined. Previous studies have highlighted the need for research aimed at developing interventions in the neuro-nursing area. The objective of this paper was to describe the development of a nursing intervention aimed at optimising the inpatient rehabilitation of stroke patients by strengthening the role and functions of nursing staff. A systematic approach was used, consistent with the framework for developing and evaluating complex interventions by the UK's Medical Research Council (MRC). Based on qualitative methods and using the Behaviour Change Wheel's (BCW) stepwise approach, we sought behaviours related to nursing staffs' roles and functions. We conducted a behavioural analysis to explain why nursing staff were or were not engaged in these behaviours. The nursing staff's Capability, Opportunity and Motivation were analysed with regard to working systematically with a rehabilitative approach and working deliberately and systematically with the patient's goals. We developed the educational intervention Rehabilitation 24/7. Following the MRC and the BCW frameworks is resource-consuming, but offers a way of developing a practical, well-structured intervention that is theory- and evidence based.

 


Evaluation of a tailored, multi-component intervention for implementation of evidence-based clinical practice guidelines in primary care physical therapy: a non-randomized controlled trial.

Susanne Bernhardsson, Maria EH Larsson, Robert Eggertsen, Monika Fagevik Olsén, Kajsa Johansson, Per Nilsen, Lena Nordeman, Maurits van Tulder, Birgitta Öberg

BMC health services research [14:105] (2014)

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Clinical practice guidelines are important for transmitting research findings into practice and facilitating the application of evidence-based practice (EBP). There is a paucity of knowledge about the impact of guideline implementation strategies in primary care physical therapy. The aim of this study was to evaluate the effect of a guideline implementation intervention in primary care physical therapy in western Sweden. An implementation strategy based on theory and current evidence was developed. A tailored, multi-component implementation intervention, addressing earlier identified determinants, was carried out in three areas comprising 28 physical therapy practices including 277 physical therapists (PTs) (intervention group). In two adjacent areas, 171 PTs at 32 practices received no intervention (control group). The core component of the intervention was an implementation seminar with group discussions. Among other components were a website and email reminders. Data were collected at baseline and follow-up with a web-based questionnaire. Primary outcomes were the self-reported awareness of, knowledge of, access to, and use of guidelines. Secondary outcomes were self-reported attitudes toward EBP and guidelines. Analyses were performed using Pearson's χ2 test and approximative z-test. 168 PTs (60.6%) in the intervention group and 88 PTs (51.5%) in the control group responded to the follow-up questionnaire. 186/277 PTs (67.1%) participated in the implementation seminars, of which 97 (52.2%) responded. The proportions of PTs reporting awareness of (absolute difference in change 20.6%, p = 0.023), knowledge where to find (20.4%, p = 0.007), access to (21.7%, p < 0.001), and frequent use of (9.5%, NS) guidelines increased more in the intervention group than in the control group. The proportion of PTs reporting frequent guideline use after participation in the implementation seminar was 15.2% (p = 0.043) higher than the proportion in the control group. A higher proportion considered EBP helpful in decision making (p = 0.018). There were no other significant differences in secondary outcomes. A tailored, theory- and evidence-informed, multi-component intervention for the implementation of clinical practice guidelines had a modest, positive effect on awareness of, knowledge of, access to, and use of guidelines, among PTs in primary care in western Sweden. In general, attitudes to EBP and guidelines were not affected.

 


The demonstration of a theory-based approach to the design of localized patient safety interventions.

Natalie Taylor, Rebecca Lawton, Beverley Slater, Robbie Foy

Implementation science : IS [8:123] (2013)

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There is evidence of unsafe care in healthcare systems globally. Interventions to implement recommended practice often have modest and variable effects. Ideally, selecting and adapting interventions according to local contexts should enhance effects. However, the means by which this can happen is seldom systematic, based on theory, or made transparent. This work aimed to demonstrate the applicability, feasibility, and acceptability of a theoretical domains framework implementation (TDFI) approach for co-designing patient safety interventions. We worked with three hospitals to support the implementation of evidence-based guidance to reduce the risk of feeding into misplaced nasogastric feeding tubes. Our stepped process, informed by the TDF and key principles from implementation literature, entailed: involving stakeholders; identifying target behaviors; identifying local factors (barriers and levers) affecting behavior change using a TDF-based questionnaire; working with stakeholders to generate specific local strategies to address key barriers; and supporting stakeholders to implement strategies. Exit interviews and audit data collection were undertaken to assess the feasibility and acceptability of this approach. Following audit and discussion, implementation teams for each Trust identified the process of checking the positioning of nasogastric tubes prior to feeding as the key behavior to target. Questionnaire results indicated differences in key barriers between organizations. Focus groups generated innovative, generalizable, and adaptable strategies for overcoming barriers, such as awareness events, screensavers, equipment modifications, and interactive learning resources. Exit interviews identified themes relating to the benefits, challenges, and sustainability of this approach. Time trend audit data were collected for 301 patients over an 18-month period for one Trust, suggesting clinically significant improved use of pH and documentation of practice following the intervention. The TDF is a feasible and acceptable framework to guide the implementation of patient safety interventions. The stepped TDFI approach engages healthcare professionals and facilitates contextualization in identifying the target behavior, eliciting local barriers, and selecting strategies to address those barriers. This approach may be of use to implementation teams and policy makers, although our promising findings confirm the need for a more rigorous evaluation; a balanced block evaluation is currently underway.

 


A Technological Innovation to Reduce Prescribing Errors Based on Implementation Intentions: The Acceptability and Feasibility of MyPrescribe.

Chris Keyworth, Jo Hart, Hong Thoong, Jane Ferguson, Mary Tully

JMIR human factors [4:e17] (2017)

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Although prescribing of medication in hospitals is rarely an error-free process, prescribers receive little feedback on their mistakes and ways to change future practices. Audit and feedback interventions may be an effective approach to modifying the clinical practice of health professionals, but these may pose logistical challenges when used in hospitals. Moreover, such interventions are often labor intensive. Consequently, there is a need to develop effective and innovative interventions to overcome these challenges and to improve the delivery of feedback on prescribing. Implementation intentions, which have been shown to be effective in changing behavior, link critical situations with an appropriate response; however, these have rarely been used in the context of improving prescribing practices. Semistructured qualitative interviews were conducted to evaluate the acceptability and feasibility of providing feedback on prescribing errors via MyPrescribe, a mobile-compatible website informed by implementation intentions. Data relating to 200 prescribing errors made by 52 junior doctors were collected by 11 hospital pharmacists. These errors were populated into MyPrescribe, where prescribers were able to construct their own personalized action plans. Qualitative interviews with a subsample of 15 junior doctors were used to explore issues regarding feasibility and acceptability of MyPrescribe and their experiences of using implementation intentions to construct prescribing action plans. Framework analysis was used to identify prominent themes, with findings mapped to the behavioral components of the COM-B model (capability, opportunity, motivation, and behavior) to inform the development of future interventions. MyPrescribe was perceived to be effective in providing opportunities for critical reflection on prescribing errors and to complement existing training (such as junior doctors' e-portfolio). The participants were able to provide examples of how they would use "If-Then" plans for patient management. Technology, as opposed to other methods of learning (eg, traditional "paper based" learning), was seen as a positive advancement for continued learning. MyPrescribe was perceived as an acceptable and feasible learning tool for changing prescribing practices, with participants suggesting that it would make an important addition to medical prescribers' training in reflective practice. MyPrescribe is a novel theory-based technological innovation that provides the platform for doctors to create personalized implementation intentions. Applying the COM-B model allows for a more detailed understanding of the perceived mechanisms behind prescribing practices and the ways in which interventions aimed at changing professional practice can be implemented.

 


Bridging the gap between pragmatic intervention design and theory: using behavioural science tools to modify an existing quality improvement programme to implement "Sepsis Six".

Siri Steinmo, Susan Michie, Christopher Fuller, Sarah Stanley, Caitriona Stapleton, Sheldon Stone

Implementation science : IS [11:14] (2016)

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Sepsis has a mortality rate of 40 %, which can be halved if the evidence-based "Sepsis Six" care bundle is implemented within 1 h. UK audit shows low implementation rates. Interventions to improve this have had minimal effects. Quality improvement programmes could be further developed by using theoretical frameworks (Theoretical Domains Framework (TDF)) to modify existing interventions by identifying influences on clinical behaviour and selecting appropriate content. The aim of this study was to illustrate using this process to modify an intervention designed using plan-do-study-act (P-D-S-A) cycles that had achieved partial success in improving Sepsis Six implementation in one hospital. Factors influencing implementation were investigated using the TDF to analyse interviews with 34 health professionals. The nursing team who developed and facilitated the intervention used the data to select modifications using the Behaviour Change Technique (BCT) Taxonomy (v1) and the APEASE criteria: affordability, practicability, effectiveness, acceptability, safety and equity. Five themes were identified as influencing implementation and guided intervention modification. These were:(1) "knowing what to do and why" (TDF domains knowledge, social/professional role and identity); (2) "risks and benefits" (beliefs about consequences), e.g. fear of harming patients through fluid overload acting as a barrier to implementation versus belief in the bundle's effectiveness acting as a lever to implementation; (3) "working together" (social influences, social/professional role and identity), e.g. team collaboration acting as a lever versus doctor/nurse conflict acting as a barrier; (4) "empowerment and support" (beliefs about capabilities, social/professional role and identity, behavioural regulation, social influences), e.g. involving staff in intervention development acting as a lever versus lack of confidence to challenge colleagues' decisions not to implement acting as a barrier; (5) "staffing levels" (environmental context and resources), e.g. shortages of doctors at night preventing implementation. The modified intervention included six new BCTs and consisted of two additional components (Sepsis Six training for the Hospital at Night Co-ordinator; a partnership agreement endorsing engagement of all clinical staff and permitting collegial challenge) and modifications to two existing components (staff education sessions; documents and materials). This work demonstrates the feasibility of the TDF and BCT Taxonomy (v1) for developing an existing quality improvement intervention. The tools are compatible with the pragmatic P-D-S-A cycle approach generally used in quality improvement work.

 


Time for action-Improving the design and reporting of behaviour change interventions for antimicrobial stewardship in hospitals: Early findings from a systematic review.

Peter Davey, Claire Peden, Esmita Charani, Charis Marwick, Susan Michie

International journal of antimicrobial agents [45:203-12] (2015)

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There is strong evidence that self-monitoring and feedback are effective behaviour change techniques (BCTs) across a range of healthcare interventions and that their effectiveness is enhanced by goal setting and action planning. Here we report a summary of the update of a systematic review assessing the application of these BCTs to improving hospital antibiotic prescribing. This paper includes studies with valid prescribing outcomes published before the end of December 2012. We used a structured method for reporting these BCTs in terms of specific characteristics and contacted study authors to request additional intervention information. We identified 116 studies reporting 123 interventions. Reporting of BCTs was poor, with little detail of BCT characteristics. Feedback was only reported for 17 (13.8%) of the interventions, and self-monitoring was used in only 1 intervention. Goals were reported for all interventions but were poorly specified, with only three of the nine characteristics reported for ≥50% of interventions. A goal threshold and timescale were specified for just 1 of the 123 interventions. Only 29 authors (25.0%) responded to the request for additional information. In conclusion, both the content and reporting of interventions for antimicrobial stewardship fell short of scientific principles and practices. There is a strong evidence base regarding BCTs in other contexts that should be applied to antimicrobial stewardship now if we are to further our understanding of what works, for whom, why and in what contexts.

 


Interventions to enhance effective communication during over-the-counter consultations in the community pharmacy setting: A systematic review.

Liza Seubert, Kerry Whitelaw, Laetitia Hattingh, Margaret Watson, Rhonda Clifford

Research in social & administrative pharmacy : RSAP (2017)

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Easy access to effective over-the-counter (OTC) treatments allows self-management of some conditions, however inappropriate or incorrect supply or use of OTC medicines can cause harm. Pharmacy personnel should support consumers in their health-seeking behaviour by utilising effective communication skills underpinned by clinical knowledge. To identify interventions targeted towards improving communication between consumers and pharmacy personnel during OTC consultations in the community pharmacy setting. Systematic review and narrative analysis. Databases searched were MEDLINE, EMBASE, Psycinfo, Cochrane Central Register and Cochrane Database of Systematic Reviews for literature published between 2000 and 30 October 2014, as well as reference lists of included articles. The search was re-run on 18 January 2016 and 25 September 2017 to maximise the currency. Two reviewers independently screened retrieved articles for inclusion, assessed study quality and extracted data. Full publications of intervention studies were included. Participants were community pharmacy personnel and/or consumers involved in OTC consultations. Interventions which aimed to improve communication during OTC consultations in the community pharmacy setting were included if they involved a direct measurable communication outcome. Studies reporting attitudes and measures not quantifiable were excluded. The protocol was published on Prospero Database of Systematic Reviews. Of 4978 records identified, 11 studies met inclusion criteria. Interventions evaluated were: face-to-face training sessions (n = 10); role-plays (n = 9); a software decision making program (n = 1); and simulated patient (SP) visits followed by immediate feedback (n = 1). Outcomes were measured using: SP methodology (n = 10) and a survey (n = 1), with most (n = 10) reporting a level of improvement in some communication behaviours. Empirical evaluation of interventions using active learning techniques such as face-to-face training with role-play can improve some communication skills. However interventions that are not fully described limit the ability for replication and/or generalisability. This review identified interventions targeting pharmacy personnel. Future interventions to improve communication should consider the consumer's role in OTC consultations.

 


Identifying the barriers and enablers for a triage, treatment, and transfer clinical intervention to manage acute stroke patients in the emergency department: a systematic review using the theoretical domains framework (TDF).

Louise Craig, Elizabeth McInnes, Natalie Taylor, Rohan Grimley, Dominique Cadilhac, Julie Considine, Sandy Middleton

Implementation science : IS [11:157] (2016)

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Clinical guidelines recommend that assessment and management of patients with stroke commences early including in emergency departments (ED). To inform the development of an implementation intervention targeted in ED, we conducted a systematic review of qualitative and quantitative studies to identify relevant barriers and enablers to six key clinical behaviours in acute stroke care: appropriate triage, thrombolysis administration, monitoring and management of temperature, blood glucose levels, and of swallowing difficulties and transfer of stroke patients in ED. Studies of any design, conducted in ED, where barriers or enablers based on primary data were identified for one or more of these six clinical behaviours. Major biomedical databases (CINAHL, OVID SP EMBASE, OVID SP MEDLINE) were searched using comprehensive search strategies. The barriers and enablers were categorised using the theoretical domains framework (TDF). The behaviour change technique (BCT) that best aligned to the strategy each enabler represented was selected for each of the reported enablers using a standard taxonomy. Five qualitative studies and four surveys out of the 44 studies identified met the selection criteria. The majority of barriers reported corresponded with the TDF domains of "environmental, context and resources" (such as stressful working conditions or lack of resources) and "knowledge" (such as lack of guideline awareness or familiarity). The majority of enablers corresponded with the domains of "knowledge" (such as education for physicians on the calculated risk of haemorrhage following intravenous thrombolysis [tPA]) and "skills" (such as providing opportunity to treat stroke cases of varying complexity). The total number of BCTs assigned was 18. The BCTs most frequently assigned to the reported enablers were "focus on past success" and "information about health consequences." Barriers and enablers for the delivery of key evidence-based protocols in an emergency setting have been identified and interpreted within a relevant theoretical framework. This new knowledge has since been used to select specific BCTs to implement evidence-based care in an ED setting. It is recommended that findings from similar future reviews adopt a similar theoretical approach. In particular, the use of existing matrices to assist the selection of relevant BCTs.

 


Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) a pragmatic three-arm cluster randomised trial: designing the intervention (ClinicalTrials.gov registration NCT01602705).

Karen Barnett, Marion Bennie, Shaun Treweek, Christopher Robertson, Dennis Petrie, Lewis Ritchie, Bruce Guthrie

Implementation science : IS [9:133] (2014)

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High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices. The NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: (1) educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study. Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2×). The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings. ClinicalTrials.gov: NCT01602705.

 


Paper-based and web-based intervention modeling experiments identified the same predictors of general practitioners' antibiotic-prescribing behavior.

Shaun Treweek, Debbie Bonetti, Graeme Maclennan, Karen Barnett, Martin Eccles, Claire Jones, Nigel Pitts, Ian Ricketts, Frank Sullivan, Mark Weal, Jill Francis

Journal of clinical epidemiology [67:296-304] (2014)

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To evaluate the robustness of the intervention modeling experiment (IME) methodology as a way of developing and testing behavioral change interventions before a full-scale trial by replicating an earlier paper-based IME. Web-based questionnaire and clinical scenario study. General practitioners across Scotland were invited to complete the questionnaire and scenarios, which were then used to identify predictors of antibiotic-prescribing behavior. These predictors were compared with the predictors identified in an earlier paper-based IME and used to develop a new intervention. Two hundred seventy general practitioners completed the questionnaires and scenarios. The constructs that predicted simulated behavior and intention were attitude, perceived behavioral control, risk perception/anticipated consequences, and self-efficacy, which match the targets identified in the earlier paper-based IME. The choice of persuasive communication as an intervention in the earlier IME was also confirmed. Additionally, a new intervention, an action plan, was developed. A web-based IME replicated the findings of an earlier paper-based IME, which provides confidence in the IME methodology. The interventions will now be evaluated in the next stage of the IME, a web-based randomized controlled trial.

 


Development of a behaviour change intervention: a case study on the practical application of theory.

Mark Porcheret, Chris Main, Peter Croft, Robert McKinley, Andrew Hassell, Krysia Dziedzic

Implementation science : IS [9:42] (2014)

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Use of theory in implementation of complex interventions is widely recommended. A complex trial intervention, to enhance self-management support for people with osteoarthritis (OA) in primary care, needed to be implemented in the Managing Osteoarthritis in Consultations (MOSAICS) trial. One component of the trial intervention was delivery by general practitioners (GPs) of an enhanced consultation for patients with OA. The aim of our case study is to describe the systematic selection and use of theory to develop a behaviour change intervention to implement GP delivery of the enhanced consultation. The development of the behaviour change intervention was guided by four theoretical models/frameworks: i) an implementation of change model to guide overall approach, ii) the Theoretical Domains Framework (TDF) to identify relevant determinants of change, iii) a model for the selection of behaviour change techniques to address identified determinants of behaviour change, and iv) the principles of adult learning. Methods and measures to evaluate impact of the behaviour change intervention were identified. The behaviour change intervention presented the GPs with a well-defined proposal for change; addressed seven of the TDF domains (e.g., knowledge, skills, motivation and goals); incorporated ten behaviour change techniques (e.g., information provision, skills rehearsal, persuasive communication); and was delivered in workshops that valued the expertise and professional values of GPs. The workshops used a mixture of interactive and didactic sessions, were facilitated by opinion leaders, and utilised 'context-bound communication skills training.' Methods and measures selected to evaluate the behaviour change intervention included: appraisal of satisfaction with workshops, GP report of intention to practise and an assessment of video-recorded consultations of GPs with patients with OA. A stepped approach to the development of a behaviour change intervention, with the utilisation of theoretical frameworks to identify determinants of change matched with behaviour change techniques, has enabled a systematic and theory-driven development of an intervention designed to enhance consultations by GPs for patients with OA. The success of the behaviour change intervention in practice will be evaluated in the context of the MOSAICS trial as a whole, and will inform understanding of practice level and patient outcomes in the trial.

 


Developing a targeted, theory-informed implementation intervention using two theoretical frameworks to address health professional and organisational factors: a case study to improve the management of mild traumatic brain injury in the emergency department.

Emma Tavender, Marije Bosch, Russell Gruen, Sally Green, Susan Michie, Sue Brennan, Jill Francis, Jennie Ponsford, Jonathan Knott, Sue Meares, Tracy Smyth, Denise O'Connor

Implementation science : IS [10:74] (2015)

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Despite the availability of evidence-based guidelines for the management of mild traumatic brain injury in the emergency department (ED), variations in practice exist. Interventions designed to implement recommended behaviours can reduce this variation. Using theory to inform intervention development is advocated; however, there is no consensus on how to select or apply theory. Integrative theoretical frameworks, based on syntheses of theories and theoretical constructs relevant to implementation, have the potential to assist in the intervention development process. This paper describes the process of applying two theoretical frameworks to investigate the factors influencing recommended behaviours and the choice of behaviour change techniques and modes of delivery for an implementation intervention. A stepped approach was followed: (i) identification of locally applicable and actionable evidence-based recommendations as targets for change, (ii) selection and use of two theoretical frameworks for identifying barriers to and enablers of change (Theoretical Domains Framework and Model of Diffusion of Innovations in Service Organisations) and (iii) identification and operationalisation of intervention components (behaviour change techniques and modes of delivery) to address the barriers and enhance the enablers, informed by theory, evidence and feasibility/acceptability considerations. We illustrate this process in relation to one recommendation, prospective assessment of post-traumatic amnesia (PTA) by ED staff using a validated tool. Four recommendations for managing mild traumatic brain injury were targeted with the intervention. The intervention targeting the PTA recommendation consisted of 14 behaviour change techniques and addressed 6 theoretical domains and 5 organisational domains. The mode of delivery was informed by six Cochrane reviews. It was delivered via five intervention components : (i) local stakeholder meetings, (ii) identification of local opinion leader teams, (iii) a train-the-trainer workshop for appointed local opinion leaders, (iv) local training workshops for delivery by trained local opinion leaders and (v) provision of tools and materials to prompt recommended behaviours. Two theoretical frameworks were used in a complementary manner to inform intervention development in managing mild traumatic brain injury in the ED. The effectiveness and cost-effectiveness of the developed intervention is being evaluated in a cluster randomised trial, part of the Neurotrauma Evidence Translation (NET) program.

 


Use of the theoretical domains framework to develop an intervention to improve physical therapist management of the risk of falls after discharge.

S Thomas, S Mackintosh

Physical therapy [94:1660-75] (2014)

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Older adults have an increased risk of falls after discharge from the hospital. Guidelines to manage this risk of falls are well documented but are not commonly implemented. The aim of this case report is to describe the novel approach of using the Theoretical Domains Framework (TDF) to develop an intervention to change the clinical behavior of physical therapists. This project had 4 phases: identifying the evidence-practice gap, identifying barriers and enablers that needed to be addressed, identifying behavior change techniques to overcome the barriers, and determining outcome measures for evaluating behavior change. The evidence-practice gap was represented by the outcome that few patients who had undergone surgery for hip fracture were recognized as having a risk of falls or had a documented referral to a community agency for follow-up regarding the prevention of falls. Project aims aligned with best practice guidelines were established; 12 of the 14 TDF domains were considered to be relevant to behaviors in the project, and 6 behavior change strategies were implemented. Primary outcome measures included the proportion of patients who had documentation of the risk of falls and were referred for a comprehensive assessment of the risk of falls after discharge from the hospital. A systematic approach involving the TDF was useful for designing a multifaceted intervention to improve physical therapist management of the risk of falls after discharge of patients from an acute care setting in South Australia, Australia. This framework enabled the identification of targeted intervention strategies that were likely to influence health care professional behavior. Early case note audit results indicated that positive changes were being made to reduce the evidence-practice gap.

 


Improving correctional healthcare providers' ability to care for transgender patients: Development and evaluation of a theory-driven cultural and clinical competence intervention.

Hughto White, M Jaclyn, Kirsty Clark, Frederick Altice, Sari Reisner, Trace Kershaw, John Pachankis

Social science & medicine (1982) [195:159-169] (2017)

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Correctional healthcare providers' limited cultural and clinical competence to care for transgender patients represents a barrier to care for incarcerated transgender individuals. The present study aimed to adapt, deliver, and evaluate a transgender cultural and clinical competence intervention for correctional healthcare providers. In the summer of 2016, a theoretically-informed, group-based intervention to improve transgender cultural and clinical competence was delivered to 34 correctional healthcare providers in New England. A confidential survey assessed providers' cultural and clinical competence to care for transgender patients, self-efficacy to provide hormone therapy, subjective norms related to transgender care, and willingness to provide gender-affirming care to transgender patients before and after (immediately and 3-months) the intervention. Linear mixed effects regression models were fit to assess change in study outcomes over time. Qualitative exit interviews assessed feasibility and acceptability of the intervention. Providers' willingness to provide gender-affirming care improved immediately post-intervention (β = 0.38; SE = 0.41, p < 0.001) and from baseline to 3-months post-intervention (β = 0.36; SE = 0.09; p < 0.001; omnibus test of fixed effects χ = 23.21; p < 0.001). On average, transgender cultural competence (χ = 22.49; p < 0.001), medical gender affirmation knowledge (χ = 11.24; p = 0.01), self-efficacy to initiate hormones for transgender women, and subjective norms related to transgender care (χ = 14.69; p = 0.001) all significantly increased over time. Providers found the intervention to be highly acceptable and recommended that the training be scaled-up to other correctional healthcare providers and expanded to custody staff. The intervention increased correctional healthcare providers' cultural and clinical competence, self-efficacy, subjective norms, and willingness to provide gender-affirming care to transgender patients. Continued efforts should be made to train correctional healthcare providers in culturally and clinically competent gender-affirming care in order to improve the health of incarcerated transgender people. Future efficacy testing of this intervention is warranted.

 


General practitioner views on the determinants of test ordering: a theory-based qualitative approach to the development of an intervention to improve immunoglobulin requests in primary care.

S Cadogan, S McHugh, C Bradley, J Browne, M Cahill

Implementation science : IS [11:102] (2016)

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Research suggests that variation in laboratory requesting patterns may indicate unnecessary test use. Requesting patterns for serum immunoglobulins vary significantly between general practitioners (GPs). This study aims to explore GP's views on testing to identify the determinants of behaviour and recommend feasible intervention strategies for improving immunoglobulin test use in primary care. Qualitative semi-structured interviews were conducted with GPs requesting laboratory tests at Cork University Hospital or University Hospital Kerry in the South of Ireland. GPs were identified using a Health Service Executive laboratory list of GPs in the Cork-Kerry region. A random sample of GPs (stratified by GP requesting patterns) was generated from this list. GPs were purposively sampled based on the criteria of location (urban/rural); length of time qualified; and practice size (single-handed/group). Interviews were carried out between December 2014 and February 2015. Interviews were transcribed verbatim using NVivo 10 software and analysed using the framework analysis method. Emerging themes were mapped to the theoretical domains framework (TDF), which outlines 12 domains that can enable or inhibit behaviour change. The behaviour change wheel and behaviour change technique (BCT) taxonomy were then used to identify potential intervention strategies. Sixteen GPs were interviewed (ten males and six females). Findings suggest that intervention strategies should specifically target the key barriers to effective test ordering, while considering the context of primary care practice. Seven domains from the TDF were perceived to influence immunoglobulin test ordering behaviours and were identified as 'mechanisms for change' (knowledge, environmental context and resources, social/professional role and identity, beliefs about capabilities, beliefs about consequences, memory, attention and decision-making processes and behavioural regulation). Using these TDF domains, seven BCTs emerged as feasible 'intervention content' for targeting GPs' ordering behaviour. These included instructions on how to effectively request the test (how to perform behaviour), information on GPs' use of the test (feedback on behaviour), information about patient consequences resulting from not doing the test (information about health consequences), laboratory/consultant-based advice/education (credible source), altering the test ordering form (restructuring the physical environment), providing guidelines (prompts/cues) and adding interpretive comments to the results (adding objects to the environment). These BCTs aligned to four intervention functions: education, persuasion, environmental restructuring and enablement. This study has effectively applied behaviour change theory to identify feasible strategies for improving immunoglobulin test use in primary care using the TDF, 'behaviour change wheel' and BCT taxonomy. The identified BCTs will form the basis of a theory-based intervention to improve the use of immunoglobulin tests among GPs. Future research will involve the development and evaluation of this intervention.

 


Specifying content and mechanisms of change in interventions to change professionals' practice: an illustration from the Good Goals study in occupational therapy.

N Kolehmainen, JJ Francis

Implementation science : IS [7:100] (2012)

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It is widely agreed that interventions to change professionals' practice need to be clearly specified. This involves (1) selecting and defining the intervention techniques, (2) operationalising the techniques and deciding their delivery, and (3) formulating hypotheses about the mechanisms through which the techniques are thought to result in change. Descriptions of methods to achieve these objectives are limited. This paper reports methods and illustrates outputs from a study to meet these objectives, specifically from the Good Goals study to improve occupational therapists' caseload management practice. (1) Behaviour change techniques were identified and selected from an existing matrix that maps techniques to determinants. An existing coding manual was used to define the techniques. (2) A team of occupational therapists generated context-relevant, acceptable modes of delivery for the techniques; these data were compared and contrasted with previously collected data, literature on caseload management, and the aims of the intervention. (3) Hypotheses about the mechanisms of change were formulated by drawing on the matrix and on theories of behaviour change. (1) Eight behaviour change techniques were selected: goal specified; self-monitoring; contract; graded tasks; increasing skills (problem solving, decision making, goal setting); coping skills; rehearsal of relevant skills; social processes of encouragement, support, and pressure; demonstration by others; and feedback. (2) A range of modes of delivery were generated (e.g., graded tasks' consisting of series of clinical cases and situations that become increasingly difficult). Conditions for acceptable delivery were identified (e.g., 'self-monitoring' was acceptable only if delivered at team level). The modes of delivery were specified as face-to-face training, task sheets, group tasks, DVDs, and team-based weekly meetings. (3) The eight techniques were hypothesized to target caseload management practice through eleven mediating variables. Three domains were hypothesized to be most likely to change: beliefs about capabilities, motivation and goals, and behavioural regulation. The project provides an exemplar of a systematic and reportable development of a quality-improvement intervention, with its methods likely to be applicable to other projects. A subsequent study of the intervention has provided early indication that use of systematic methods to specify interventions may help to maximize acceptability and effectiveness.

 



An Audit and Feedback Intervention for Reducing Antibiotic Prescribing in General Dental Practice: The RAPiD Cluster Randomised Controlled Trial.

Paula Elouafkaoui, Linda Young, Rumana Newlands, Eilidh Duncan, Andrew Elders, Jan Clarkson, Craig Ramsay

PLoS medicine [13:e1002115] (2016)

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Dentists prescribe approximately 10% of antibiotics dispensed in UK community pharmacies. Despite clear clinical guidance, dentists often prescribe antibiotics inappropriately. This cluster-randomised controlled trial used routinely collected National Health Service (NHS) dental prescribing and treatment claim data to compare the impact of individualised audit and feedback (A&F) interventions on dentists' antibiotic prescribing rates. All 795 antibiotic prescribing NHS general dental practices in Scotland were included. Practices were randomised to the control (practices = 163; dentists = 567) or A&F intervention group (practices = 632; dentists = 1,999). A&F intervention practices were allocated to one of two A&F groups: (1) individualised graphical A&F comprising a line graph plotting an individual dentist's monthly antibiotic prescribing rate (practices = 316; dentists = 1,001); or (2) individualised graphical A&F plus a written behaviour change message synthesising and reiterating national guidance recommendations for dental antibiotic prescribing (practices = 316; dentists = 998). Intervention practices were also simultaneously randomised to receive A&F: (i) with or without a health board comparator comprising the addition of a line to the graphical A&F plotting the monthly antibiotic prescribing rate of all dentists in the health board; and (ii) delivered at 0 and 6 mo or at 0, 6, and 9 mo, giving a total of eight intervention groups. The primary outcome, measured by the trial statistician who was blinded to allocation, was the total number of antibiotic items dispensed per 100 NHS treatment claims over the 12 mo post-delivery of the baseline A&F. Primary outcome data was available for 152 control practices (dentists = 438) and 609 intervention practices (dentists = 1,550). At baseline, the number of antibiotic items prescribed per 100 NHS treatment claims was 8.3 in the control group and 8.5 in the intervention group. At follow-up, antibiotic prescribing had decreased by 0.4 antibiotic items per 100 NHS treatment claims in control practices and by 1.0 in intervention practices. This represents a significant reduction (-5.7%; 95% CI -10.2% to -1.1%; p = 0.01) in dentists' prescribing rate in the intervention group relative to the control group. Intervention subgroup analyses found a 6.1% reduction in the antibiotic prescribing rate of dentists who had received the written behaviour change message relative to dentists who had not (95% CI -10.4% to -1.9%; p = 0.01). There was no significant between-group difference in the prescribing rate of dentists who received a health board comparator relative to those who did not (-4.3%; 95% CI -8.6% to 0.1%; p = 0.06), nor between dentists who received A&F at 0 and 6 mo relative to those who received A&F at 0, 6, and 9 mo (0.02%; 95% CI -4.2% to 4.2%; p = 0.99). The key limitations relate to the use of routinely collected datasets which did not allow evaluation of any effects on inappropriate prescribing. A&F derived from routinely collected datasets led to a significant reduction in the antibiotic prescribing rate of dentists. Current Controlled Trials ISRCTN49204710.

 


The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

Ben Darlow, James Stanley, Sarah Dean, J Haxby Abbott, Sue Garrett, Fiona Mathieson, Anthony Dowell

Trials [18:484] (2017)

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Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care. This is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care. Secondary GP outcomes include beliefs about pain and impairment, GP confidence, and actual and reported clinical behaviour. Health economic and process evaluations will be conducted. In the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care. Australian New Zealand Clinical Trials Registry, ACTRN12616000888460 . Registered on 6 July 2016.

 


Applying the Theoretical Domains Framework to identify barriers and targeted interventions to enhance nurses' use of electronic medication management systems in two Australian hospitals.

Deborah Debono, Natalie Taylor, Wendy Lipworth, David Greenfield, Joanne Travaglia, Deborah Black, Jeffrey Braithwaite

Implementation science : IS [12:42] (2017)

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Medication errors harm hospitalised patients and increase health care costs. Electronic Medication Management Systems (EMMS) have been shown to reduce medication errors. However, nurses do not always use EMMS as intended, largely because implementation of such patient safety strategies requires clinicians to change their existing practices, routines and behaviour. This study uses the Theoretical Domains Framework (TDF) to identify barriers and targeted interventions to enhance nurses' appropriate use of EMMS in two Australian hospitals. This qualitative study draws on in-depth interviews with 19 acute care nurses who used EMMS. A convenience sampling approach was used. Nurses working on the study units (N = 6) in two hospitals were invited to participate if available during the data collection period. Interviews inductively explored nurses' experiences of using EMMS (step 1). Data were analysed using the TDF to identify theory-derived barriers to nurses' appropriate use of EMMS (step 2). Relevant behaviour change techniques (BCTs) were identified to overcome key barriers to using EMMS (step 3) followed by the identification of potential literature-informed targeted intervention strategies to operationalise the identified BCTs (step 4). Barriers to nurses' use of EMMS in acute care were represented by nine domains of the TDF. Two closely linked domains emerged as major barriers to EMMS use: Environmental Context and Resources (availability and properties of computers on wheels (COWs); technology characteristics; specific contexts; competing demands and time pressure) and Social/Professional Role and Identity (conflict between using EMMS appropriately and executing behaviours critical to nurses' professional role and identity). The study identified three potential BCTs to address the Environmental Context and Resources domain barrier: adding objects to the environment; restructuring the physical environment; and prompts and cues. Seven BCTs to address Social/Professional Role and Identity were identified: social process of encouragement; pressure or support; information about others' approval; incompatible beliefs; identification of self as role model; framing/reframing; social comparison; and demonstration of behaviour. It proposes several targeted interventions to deliver these BCTs. The TDF provides a useful approach to identify barriers to nurses' prescribed use of EMMS, and can inform the design of targeted theory-based interventions to improve EMMS implementation.

 


Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework.

Simon French, Sally Green, Denise O'Connor, Joanne McKenzie, Jill Francis, Susan Michie, Rachelle Buchbinder, Peter Schattner, Neil Spike, Jeremy Grimshaw

Implementation science : IS [7:38] (2012)

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There is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research. The intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood? A complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change. We have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process.

 


Implementation of a nurse-led behaviour change intervention to support medication taking in type 2 diabetes: beyond hypothesised active ingredients (SAMS Consultation Study).

Wendy Hardeman, Laura Lamming, Ian Kellar, Anna De Simoni, Jonathan Graffy, Sue Boase, Stephen Sutton, Andrew Farmer, Ann Louise Kinmonth

Implementation science : IS [9:70] (2014)

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Implementation of trial interventions is rarely assessed, despite its effects on findings. We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes (SAMS) in a trial against standard care in general practice. The intervention increased adherence, but not through the hypothesised psychological mechanism. This study aimed to develop a reliable coding frame for tape-recorded consultations, assessing both a priori hypothesised and potential active ingredients observed during implementation, and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked. 211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded. Practice nurses delivered standard care to all patients and motivational and action planning (implementation intention) techniques to intervention patients only. The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved. All tape-recorded consultations were coded and a random subsample double-coded. Nurse communication, nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques. The coding frame proved reliable. Intervention and standard care were clearly differentiated. Nurse protocol adherence was good (M (SD) = 3.95 (0.91)) and competence of intervention delivery moderate (M (SD) = 3.15 (1.01)). Nurses frequently reinforced positive beliefs about taking medication (e.g., 65% for advantages) but rarely prompted problem solving of negative beliefs (e.g., 21% for barriers). Patients' action plans were virtually identical to current routines. Nurses showed significantly less patient-centred communication with the intervention than comparison group. It is feasible to reliably assess the implementation of behaviour change interventions in clinical practice. The main study results could not be explained by poor delivery of motivational and action planning components, definition of new action plans, improved problem solving or patient-centred communication. Possible mechanisms of increased medication adherence include spending more time discussing it and mental rehearsal of successful performance of current routines, combined with action planning. Delivery of a new behaviour change intervention may lead to less patient-centred communication and possible reduction in overall trial effects. ISRCTN30522359.

 


Improving medication management in multimorbidity: development of the MultimorbiditY COllaborative Medication Review And DEcision Making (MY COMRADE) intervention using the Behaviour Change Wheel.

Carol Sinnott, Stewart Mercer, Rupert Payne, Martin Duerden, Colin Bradley, Molly Byrne

Implementation science : IS [10:132] (2015)

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Multimorbidity, the presence of two or more chronic conditions, affects over 60 % of patients in primary care. Due to its association with polypharmacy, the development of interventions to optimise medication management in patients with multimorbidity is a priority. The Behaviour Change Wheel is a new approach for applying behavioural theory to intervention development. Here, we describe how we have used results from a review of previous research, original research of our own and the Behaviour Change Wheel to develop an intervention to improve medication management in multimorbidity by general practitioners (GPs), within the overarching UK Medical Research Council guidance on complex interventions. Following the steps of the Behaviour Change Wheel, we sought behaviours associated with medication management in multimorbidity by conducting a systematic review and qualitative study with GPs. From the modifiable GP behaviours identified, we selected one and conducted a focused behavioural analysis to explain why GPs were or were not engaging in this behaviour. We used the behavioural analysis to determine the intervention functions, behavioural change techniques and implementation plan most likely to effect behavioural change. We identified numerous modifiable GP behaviours in the systematic review and qualitative study, from which active medication review (rather than passive maintaining the status quo) was chosen as the target behaviour. Behavioural analysis revealed GPs' capabilities, opportunities and motivations relating to active medication review. We combined the three intervention functions deemed most likely to effect behavioural change (enablement, environmental restructuring and incentivisation) to form the MultimorbiditY COllaborative Medication Review And DEcision Making (MY COMRADE) intervention. MY COMRADE primarily involves the technique of social support: two GPs review the medications prescribed to a complex multimorbid patient together. Four other behavioural change techniques are incorporated: restructuring the social environment, prompts/cues, action planning and self-incentives. This study is the first to use the Behaviour Change Wheel to develop an intervention targeting multimorbidity and confirms the usability and usefulness of the approach in a complex area of clinical care. The systematic development of the MY COMRADE intervention will facilitate a thorough evaluation of its effectiveness in the next phase of this work.

 


The design of a theory-based intervention to improve medication adherence in chronic pain patients.

Leon Timmerman, Dirk Stronks, Frank JPM Huygen

Current medical research and opinion (2017)

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Non-adherence to pain medication is common in chronic pain patients and may result in unfavorable treatment outcomes. Interventions to improve adherence behavior often fail to significantly change medication use. In this report, we describe the application of a theoretical psychological model of behavior change in order to design an intervention to improve medication adherence in chronic pain patients. This study applies the Behavior Change Wheel framework and the Behavior Change Techniques Taxonomy to design a theory-based intervention to improve pain medication use. Available literature was used to extract determinants of adherence in chronic pain patients. Selected target behaviors to improve medication adherence are: share agreement on follow up policy, monitor medication adherence, provide patient education routinely, discuss attitudes and concerns towards pain medication, develop medication taking habits and use medication reminders. The intervention consists of three components in which relevant behavior change techniques are applied: (1) changes in the electronic patient data management systems to enable medical staff to apply target behaviors; (2) bi-annual education of medical staff to commit the team to the proposed intervention and provide feedback; (3) routine and mandatory education of chronic pain patients following prescription of pain medication. To improve medication adherence in chronic pain patients, most interventions should be focused on providers of pain therapy. Prescribing chronic pain medication should be seen as part of a larger treatment regimen including adequate follow-up, adherence monitoring and patient education during the course of treatment.

 


A randomized controlled multimodal behavioral intervention trial for improving antiepileptic drug adherence.

Amir Pakpour, Maryam Gholami, Ravanbakhsh Esmaeili, Seyed Naghibi, John Updegraff, Gerard Molloy, Stephan Dombrowski

Epilepsy & behavior : E&B [52:133-42] (2015)

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Medication nonadherence is one of the most important reasons for treatment failure in patients with epilepsy. The present study investigated the effectiveness of a multicomponent intervention to improve adherence to antiepileptic drug (AED) medication in patients with epilepsy. In a prospective, randomized multicenter trial, three sessions of face-to-face motivational interviewing (MI) in combination with complementary behavior change techniques were compared with standard care. Motivational interviewing prompted change talk and self-motivated statements from the patients, planning their own medication intake regimen and also identifying and overcoming barriers that may prevent adherence. Participants were provided with calendars to self-monitor their medication taking behavior. A family member and the health-care team were invited to attend the last session of MI in order to improve the collaboration and communication between patients, their caregiver or family member, and their health-care provider. At baseline and 6-month follow-up, psychosocial variables and medical adherence were assessed. In total, 275 participants were included in the study. Compared with the active control group, patients in the intervention group reported significantly higher medication adherence, as well as stronger intention and perceptions of control for taking medication regularly. The intervention group also reported higher levels of action planning, coping planning, self-monitoring, and lower medication concerns. This study shows that MI can be effective in clinical practice to improve medication adherence in patients with epilepsy. It also provides evidence that combining volitional interventions, including action planning, coping planning, and self-monitoring with motivational interviewing can promote the effectiveness of the medical treatments for epilepsy by improving adherence.

 


Intensified pharmaceutical care is improving immunosuppressive medication adherence in kidney transplant recipients during the first post-transplant year: a quasi-experimental study.

Robert Joost, Frank Dörje, Judith Schwitulla, Kai-Uwe Eckardt, Christian Hugo

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association [29:1597-607] (2014)

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Medication adherence is critical for transplant patients because the consequences of non-adherence can result in allograft loss and may be life threatening. A prospective study with 74 renal transplant recipients using a sequential control group design was performed to investigate the impact of a pharmaceutical intensified care programme led by a clinical pharmacist on daily drug adherence during the first year after renal transplantation. Thirty-nine patients of the control group received the already established standardized drug and transplant training, while 35 patients of the intensified care group (ICG) received additional inpatient and outpatient pharmaceutical care and counselling by a dedicated clinical pharmacist. Applied interventions were clustered and classified using the behaviour change technique taxonomy according to Michie. Adherence to immunosuppressive drug therapy was monitored up to 1 year using a medication event monitoring system, pill count (PC), drug holiday (DH) occurrence, Morisky questionnaire and self-report. Sixty-seven patients (35 of the standard care and 32 of the ICG) were analysed. Implementation of DA was significantly (P = 0.014) improved in patients of the ICG (91%) compared with SCG (75%) during the first year after transplantion. Daily adherence measures were already improved within 30-40 days after start of intensified patient care and continued throughout the study period. Intensified care patients also showed significantly better results for taking adherence (P = 0.006), PC (P = 0.008) and DHs (P = 0.001). The additional, intensified pharmaceutical care improved patients' medication adherence remarkably, suggesting that the applied additional care programme has the potential to improve outcomes after organ transplantation.

 


A crossover trial evaluating an educational-behavioural joint protection programme for people with rheumatoid arthritis.

A Hammond, N Lincoln, L Sutcliffe

Patient education and counseling [37:19-32] (1999)

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Joint protection (JP) is a self-management technique widely taught to people with rheumatoid arthritis (RA). JP education aims to enable people with RA to reduce pain, inflammation, joint stress and reduce risks of deformity through using assistive devices and alternative movement patterns of affected joints to perform everyday activities. Previous studies evaluating JP education methods common in the UK have identified JP adherence is poor. A group education programme was developed using the Health Belief Model and Self-efficacy Theory. Strategies used to maximise JP adherence included goal-setting, contracting, modelling, homework programmes, motor learning theory, recall enhancing methods and mental practice. A crossover trial (n = 35) was conducted. Adherence with JP was measured using an objective observational test (the Joint Protection Behaviour Assessment). Significant improvements in use of JP were recorded at 12 and 24 weeks post-education (P < 0.01). No significant changes in measures of pain, functional disability, grip strength, self-efficacy or helplessness occurred post-education, although this may have been due to the small sample size recruited. In conclusion, JP adherence can be facilitated through the use of educational-behavioural strategies, suggesting this approach should be more widely adopted in clinical practice.

 



Improving adherence to multiple medications in older people in primary care: Selecting intervention components to address patient-reported barriers and facilitators.

Deborah Patton, Cathal Cadogan, Cristín Ryan, Jill Francis, Gerard Gormley, Peter Passmore, Ngaire Kerse, Carmel Hughes

Health expectations : an international journal of public participation in health care and health policy (2017)

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Medication adherence is vital to ensuring optimal patient outcomes, particularly amongst multimorbid older people prescribed multiple medications. Interventions targeting adherence often lack a theoretical underpinning and this may impact on effectiveness. The theoretical domains framework (TDF) of behaviour can aid intervention development by systematically identifying key determinants of medication adherence. This study aimed to (i) identify determinants (barriers, facilitators) of adherence to multiple medications from older people's perspectives; (ii) identify key domains to target for behaviour change; and (iii) map key domains to intervention components [behaviour change techniques (BCTs)] that could be delivered in an intervention by community pharmacists. Focus groups were conducted with older people (>65 years) receiving ≥4 medications. Questions explored the 12 domains of the TDF (eg "Knowledge," "Emotion"). Data were analysed using the framework method and content analysis. Identification of key domains and mapping to intervention components (BCTs) followed established methods. Seven focus groups were convened (50 participants). A wide range of determinants were identified as barriers (eg forgetfulness, prioritization of medications) and facilitators (eg social support, personalized routines) of adherence to multiple medications. Eight domains were identified as key targets for behaviour change (eg "Social influences," "Memory, attention and decision processes," "Motivation and goals") and mapped to 11 intervention components (BCTs) to include in an intervention [eg "Social support or encouragement (general)," "Self-monitoring of the behaviour," "Goal-setting (behaviour)"]. This study used a theoretical underpinning to identify potential intervention components (BCTs). Future work will incorporate the selected BCTs into an intervention that will undergo feasibility testing in community pharmacies.

 



Healthcare provider-led interventions to support medication adherence following ACS: a meta-analysis.

Jacob Crawshaw, Vivian Auyeung, Lucy Ashworth, Sam Norton, John Weinman

Open heart [4:e000685] (2017)

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We conducted a systematic review and meta-analysis to determine the effectiveness of healthcare provider-led (HCPs) interventions to support medication adherence in patients with acute coronary syndrome (ACS). A systematic search of Cochrane Library, Medline, EMBASE, PsycINFO, Web of Science, IPA, CINAHL, ASSIA, OpenGrey, EthOS, WorldCat and PQDT was undertaken. Interventions were deemed eligible if they included adult ACS patients, were HCP-led, measured medication adherence and randomised participants to parallel groups. Intervention content was coded using the Behaviour Change Technique (BCT) Taxonomy and data were pooled for analysis using random-effects models. Our search identified 8870 records, of which 27 were eligible (23 primary studies). A meta-analysis (n=9735) revealed HCP-led interventions increased the odds of medication adherence by 54% compared to control interventions (k=23, OR 1.54, 95% CI 1.26 to 1.88, I=57.5%). After removing outliers, there was a 41% increase in the odds of medication adherence with moderate heterogeneity (k=21, OR 1.41, 95% CI 1.21 to 1.65, I=35.3%). Interventions that included phone contact yielded (k=12, OR 1.63, 95% CI 1.25 to 2.12, I=32.0%) a larger effect compared to those delivered exclusively in person. A total of 32/93 BCTs were identified across interventions (mean=4.7, SD=2.2) with 'information about health consequences' (BCT 5.1) (19/23) the most common. HCP-led interventions for ACS patients appear to have a small positive impact on medication adherence. While we were able to identify BCTs among interventions, data were insufficient to determine the impact of particular BCTs on study effectiveness. CRD42016037706.

 


Improving medication adherence in stroke survivors: mediators and moderators of treatment effects.

Ronan O'Carroll, Julie Chambers, Martin Dennis, Cathie Sudlow, Marie Johnston

Health psychology : official journal of the Division of Health Psychology, American Psychological Association [33:1241-50] (2014)

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The purpose of the current study was to test theory-based predictions of mediators and moderators of treatment effects of a pilot randomized controlled trial, which aimed to increase adherence to preventive medication in stroke survivors via addressing both automatic (i.e., habitual responses) and reflective (i.e., beliefs and value systems) aspects of medication-taking behavior. Sixty-two stroke survivors were randomly allocated to either an intervention or control group. Intervention participants received a brief 2-session intervention aimed at increasing adherence via (a) helping patients establish better medication-taking routines using implementation intentions plans (automatic), and (b) eliciting and modifying any mistaken patient beliefs regarding medication and/or stroke (reflective). The control group received similar levels of non-medication-related contact. Primary outcome was adherence to antihypertensive medicine measured objectively over 3 months using an electronic pill bottle. Secondary outcome measures included self-reported adherence (including forgetting) and beliefs about medication. Intervention participants had 10% greater adherence on doses taken on schedule (intervention, 97%; control, 87%; 95% CI [0.2, 16.2], p = .048), as well as significantly greater increases in self-reported adherence and reductions in concerns about medication. Treatment effects were mediated by reductions in both forgetting and concerns about medication, and moderated by the presence of preexisting medication-taking routines. Addressing both automatic and reflective aspects of behavior via helping stroke survivors develop planned regular routines for medication-taking, and addressing any concerns or misconceptions about their medication, can improve adherence and thus potentially patient outcomes.

 


Beyond good intentions: The role of proactive coping in achieving sustained behavioural change in the context of diabetes management.

Bart Johan Thoolen, Denise de Ridder, Jozien Bensing, Kees Gorter, Guy Rutten

Psychology & health [24:237-54] (2009)

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This study examines the effectiveness of a brief self-management intervention to support patients recently diagnosed with type-2 diabetes to achieve sustained improvements in their self-care behaviours. Based on proactive coping, the intervention emphasizes the crucial role of anticipation and planning in maintaining self-care behaviours. In a randomised controlled trial among recent screen-detected patients, participants who received the intervention were compared with usual-care controls, examining changes in proximal outcomes (intentions, self-efficacy and proactive coping), self-care behaviour (diet, physical activity and medication) and weight over time (0, 3 and 12 months). Subsequently, the contribution of proactive coping in predicting maintenance of behavioural change was analysed using stepwise hierarchical regression analyses, controlling for baseline self-care behaviour, patient characteristics, and intentions and self-efficacy as measured after the course. The intervention was effective in improving proximal outcomes and behaviour with regard to diet and physical activity, resulting in significant weight loss at 12 months. Furthermore, proactive coping was a better predictor of long-term self-management than either intentions or self-efficacy. Proactive coping thus offers new insights into behavioural maintenance theory and can be used to develop effective self-management interventions.

 


My Interventional Drug-Eluting Stent Educational App (MyIDEA): Patient-Centered Design Methodology.

Andrew Dallas Boyd, Kaitlin Moores, Vicki Shah, Eugene Sadhu, Adhir Shroff, Vicki Groo, Carolyn Dickens, Jerry Field, Matthew Baumann, Betty Welland, Gerry Gutowski, Jose Flores, Zhongsheng Zhao, Neil Bahroos, Denise Hynes, Diana Wilkie

JMIR mHealth and uHealth [3:e74] (2015)

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Patient adherence to medication regimens is critical in most chronic disease treatment plans. This study uses a patient-centered tablet app, "My Interventional Drug-Eluting Stent Educational App (MyIDEA)." This is an educational program designed to improve patient medication adherence. Our goal is to describe the design, methodology, limitations, and results of the MyIDEA tablet app. We created a mobile technology-based patient education app to improve dual antiplatelet therapy adherence in patients who underwent a percutaneous coronary intervention and received a drug-eluting stent. Patient advisers were involved in the development process of MyIDEA from the initial wireframe to the final launch of the product. The program was restructured and redesigned based on the patient advisers' suggestions as well as those from multidisciplinary team members. To accommodate those with low health literacy, we modified the language and employed attractive color schemes to improve ease of use. We assumed that the target patient population may have little to no experience with electronic tablets, and therefore, we designed the interface to be as intuitive as possible. The MyIDEA app has been successfully deployed to a low-health-literate elderly patient population in the hospital setting. A total of 6 patients have interacted with MyIDEA for an average of 17.6 minutes/session. Including patient advisers in the early phases of a mobile patient education development process is critical. A number of changes in text order, language, and color schemes occurred to improve ease of use. The MyIDEA program has been successfully deployed to a low-health-literate elderly patient population. Leveraging patient advisers throughout the development process helps to ensure implementation success. Our goal is to describe the design, methodology, limitations, and results of the MyIDEA tablet app. We created a mobile technology-based patient education app to improve dual antiplatelet therapy adherence in patients who underwent a percutaneous coronary intervention and received a drug-eluting stent.

 


Development of an intervention to improve appropriate polypharmacy in older people in primary care using a theory-based method.

Cathal Cadogan, Cristín Ryan, Jill Francis, Gerard Gormley, Peter Passmore, Ngaire Kerse, Carmel Hughes

BMC health services research [16:661] (2016)

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It is advocated that interventions to improve clinical practice should be developed using a systematic approach and intervention development methods should be reported. However, previous interventions aimed at ensuring that older people receive appropriate polypharmacy have lacked details on their development. This study formed part of a multiphase research project which aimed to develop an intervention to improve appropriate polypharmacy in older people in primary care. The target behaviours for the intervention were prescribing and dispensing of appropriate polypharmacy to older patients by general practitioners (GPs) and community pharmacists. Intervention development followed a systematic approach, including previous mapping of behaviour change techniques (BCTs) to key domains from the Theoretical Domains Framework that were perceived by GPs and pharmacists to influence the target behaviours. Draft interventions were developed to operationalise selected BCTs through team discussion. Selection of an intervention for feasibility testing was guided by a subset of the APEASE (Affordability, Practicability, Effectiveness/cost-effectiveness, Acceptability, Side-effects/safety, Equity) criteria. Three draft interventions comprising selected BCTs were developed, targeting patients, pharmacists and GPs, respectively. Following assessment of each intervention using a subset of the APEASE criteria (affordability, practicability, acceptability), the GP-targeted intervention was selected for feasibility testing. This intervention will involve a demonstration of the behaviour and will be delivered as an online video. The video demonstrating how GPs can prescribe appropriate polypharmacy during a typical consultation with an older patient will also demonstrate salience of consequences (feedback emphasising the positive outcomes of performing the behaviour). Action plans and prompts/cues will be used as complementary intervention components. The intervention is designed to facilitate the prescribing of appropriate polypharmacy in routine practice. A GP-targeted intervention to improve appropriate polypharmacy in older people has been developed using a systematic approach. Intervention content has been specified using an established taxonomy of BCTs and selected to maximise feasibility. The results of a future feasibility study will help to determine if the theory-based intervention requires further refinement before progressing to a larger scale randomised evaluation.

 


Behavior change techniques implemented in electronic lifestyle activity monitors: a systematic content analysis.

Elizabeth Lyons, Zakkoyya Lewis, Brian Mayrsohn, Jennifer Rowland

Journal of medical Internet research [16:e192] (2014)

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Electronic activity monitors (such as those manufactured by Fitbit, Jawbone, and Nike) improve on standard pedometers by providing automated feedback and interactive behavior change tools via mobile device or personal computer. These monitors are commercially popular and show promise for use in public health interventions. However, little is known about the content of their feedback applications and how individual monitors may differ from one another. The purpose of this study was to describe the behavior change techniques implemented in commercially available electronic activity monitors. Electronic activity monitors (N=13) were systematically identified and tested by 3 trained coders for at least 1 week each. All monitors measured lifestyle physical activity and provided feedback via an app (computer or mobile). Coding was based on a hierarchical list of 93 behavior change techniques. Further coding of potentially effective techniques and adherence to theory-based recommendations were based on findings from meta-analyses and meta-regressions in the research literature. All monitors provided tools for self-monitoring, feedback, and environmental change by definition. The next most prevalent techniques (13 out of 13 monitors) were goal-setting and emphasizing discrepancy between current and goal behavior. Review of behavioral goals, social support, social comparison, prompts/cues, rewards, and a focus on past success were found in more than half of the systems. The monitors included a range of 5-10 of 14 total techniques identified from the research literature as potentially effective. Most of the monitors included goal-setting, self-monitoring, and feedback content that closely matched recommendations from social cognitive theory. Electronic activity monitors contain a wide range of behavior change techniques typically used in clinical behavioral interventions. Thus, the monitors may represent a medium by which these interventions could be translated for widespread use. This technology has broad applications for use in clinical, public health, and rehabilitation settings.

 


Evaluating a community-based walking intervention for hypertensive older people in Taiwan: a randomized controlled trial.

LL Lee, A Arthur, M Avis

Preventive medicine [44:160-6] (2007)

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To study the effect of a community-based walking intervention on blood pressure among older people. The study design was a randomized controlled trial conducted in a rural area of Taiwan between October 2002 and June 2003. A total of 202 participants aged 60 years and over with mild to moderate hypertension was recruited. Participants randomized to the intervention group (n=102) received a six-month community-based walking intervention based on self-efficacy theory. A public health nurse provided both face-to-face and telephone support designed to assist participants to increase their walking. Control group participants (n=100) received usual primary health care. Primary outcome was change in systolic blood pressure and secondary outcomes were exercise self-efficacy, self-reported walking and diastolic blood pressure. At six-month follow-up the mean change in systolic blood pressure was a decrease of 15.4 mmHg and 8.4 mmHg in the intervention and control group, respectively. The difference in mean change between the two groups was -7.0 mmHg (95% CI, -11.5 to -2.5 mmHg, p=0.002). Improvement in exercise self-efficacy scores was greater among intervention group participants (mean difference 1.23, 95% CI, 0.5 to 2.0, p=0.001). Intervention group participants were more likely to report walking more (p<0.0005) but no differences were observed in diastolic blood pressure (p=0.19). Among hypertensive older people, a six-month community-based walking intervention was effective in increasing their exercise self-efficacy and reducing systolic blood pressure.

 


Vitalum study design: RCT evaluating the efficacy of tailored print communication and telephone motivational interviewing on multiple health behaviors.

Hilde M van Keulen, Ilse Mesters, Johannes Brug, Marlein Ausems, Marci Campbell, Ken Resnicow, Paul Zwietering, Gerard van Breukelen, Willem van Mechelen, Johan Severens, Hein De Vries

BMC public health [8:216] (2008)

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A large proportion of adults fail to meet public health guidelines for physical activity as well as fruit, vegetable and fat intake. Interventions are needed to improve these health behaviors. Both computer tailoring and motivational interviewing have shown themselves to be promising techniques for health behavior change. The Vitalum project aims to compare the efficacy of these techniques in improving the health behaviors of adults aged 45-70. This paper describes the design of the Vitalum study. Dutch general medical practices (N = 23) were recruited via a registration network or by personal invitation. The participants were then enrolled through these general practices using an invitational letter. They (n = 2,881) received a written baseline questionnaire to assess health behaviors, and potential psychosocial and socio-demographic behavioral determinants. A power analysis indicated that 1,600 participants who were failing to meet the guidelines for physical activity and either fruit or vegetable consumption were needed. Eligible participants were stratified based on hypertension status and randomized into one of four intervention groups: tailored print communication, telephone motivational interviewing, combined, and control. The first two groups either received four letters or took part in four interviews, whereas the combined group received two letters and took part in two interviews in turns at 5, 13, 30 and 43 weeks after returning the baseline questionnaire. Each letter and interview focused on physical activity or nutrition behavior. The participants also took part in a telephone survey 25 weeks after baseline to gather new information for tailoring. There were two follow-up questionnaires, at 47 and 73 weeks after baseline, to measure short- and long-term effects. The control group received a tailored letter after the last posttest. The process, efficacy and cost-effectiveness of the interventions will be examined by means of multilevel mixed regression, cost-effectiveness analyses and process evaluation. The Vitalum study simultaneously evaluates the efficacy of tailored print communication and telephone motivational interviewing, and their combined use for multiple behaviors and people with different motivational stages and education levels. The results can be used by policymakers to contribute to evidence-based prevention of chronic diseases. Dutch Trial Register NTR1068.

 


Remotely Delivered Exercise-Based Cardiac Rehabilitation: Design and Content Development of a Novel mHealth Platform.

Jonathan Rawstorn, Nicholas Gant, Andrew Meads, Ian Warren, Ralph Maddison

JMIR mHealth and uHealth [4:e57] (2016)

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Participation in traditional center-based cardiac rehabilitation exercise programs (exCR) is limited by accessibility barriers. Mobile health (mHealth) technologies can overcome these barriers while preserving critical attributes of center-based exCR monitoring and coaching, but these opportunities have not yet been capitalized on. We aimed to design and develop an evidence- and theory-based mHealth platform for remote delivery of exCR to any geographical location. An iterative process was used to design and develop an evidence- and theory-based mHealth platform (REMOTE-CR) that provides real-time remote exercise monitoring and coaching, behavior change education, and social support. The REMOTE-CR platform comprises a commercially available smartphone and wearable sensor, custom smartphone and Web-based applications (apps), and a custom middleware. The platform allows exCR specialists to monitor patients' exercise and provide individualized coaching in real-time, from almost any location, and provide behavior change education and social support. Intervention content incorporates Social Cognitive Theory, Self-determination Theory, and a taxonomy of behavior change techniques. Exercise components are based on guidelines for clinical exercise prescription. The REMOTE-CR platform extends the capabilities of previous telehealth exCR platforms and narrows the gap between existing center- and home-based exCR services. REMOTE-CR can complement center-based exCR by providing an alternative option for patients whose needs are not being met. Remotely monitored exCR may be more cost-effective than establishing additional center-based programs. The effectiveness and acceptability of REMOTE-CR are now being evaluated in a noninferiority randomized controlled trial.

 


Psychosocial mediators of a theory-based resistance training maintenance intervention for prediabetic adults.

David Williams, Shira Dunsiger, Brenda Davy, Sarah Kelleher, Elaina Marinik, Richard Winett

Psychology & health [31:1108-24] (2016)

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Examine psychosocial mediators of the effects of high vs. low-dose resistance training (RT) maintenance interventions among older (ages 50-69), overweight and pre-diabetic adults. Participants (N = 123) completed a three-month supervised RT initiation phase and were subsequently randomised (time 1) to high or low-dose six-month unsupervised RT maintenance interventions (time 2), followed by a six-month no-contact phase (time 3). Online measures of putative mediators and RT behaviour. RT intervention condition (high vs. low dose) had significant effects on change from time 1 to time 2 in behavioural expectation, self-regulation and perceived satisfaction (f(2) = .04-.08), but not outcome expectancies, RT strategies or behavioural intentions (f(2) ≤ .02). Change in each of the putative mediators, except for outcome expectancies (f(2) ≤ .02), had significant effects on RT behaviour at times 2 (f(2) = .12-.27) and 3 (f(2) = .23-.40). In a multiple mediation model, behavioural expectation (f(2) = .11) and self-regulation (f(2) = .06) mediated the effects of RT intervention condition on time 2 RT behaviour, whereas perceived satisfaction did not (f(2) = .01). Self-regulation was a significant mediator of intervention effects on time 3 RT behaviour (f(2) = .11), but behavioural expectation and perceived satisfaction were not (f(2) = .04). Findings suggest that behavioural expectation and self-regulation are appropriate targets for RT maintenance interventions among at-risk older adults.

 


Reducing cardiovascular risk factors in postmenopausal women through a lifestyle change intervention.

Robert Carels, Lynn Darby, Holly Cacciapaglia, Olivia Douglass

Journal of women's health (2002) [13:412-26] (2004)

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The impact of a 6-month lifestyle change intervention on cardiovascular risk factors in obese, sedentary, postmenopausal women was examined. A secondary aim of this investigation was to determine whether the addition of self-control skills training to an empirically supported lifestyle change intervention would result in greater cardiovascular risk reduction. Forty-four women were randomly assigned to receive either a lifestyle change or a lifestyle change with self-control skills intervention. Pretreatment and posttreatment weight loss, body composition, physical activity, cardiorespiratory fitness, diet, blood pressure (BP), blood lipids, and psychosocial functioning were assessed. Also, at 1-year posttreatment, weight loss, body composition, self-reported physical activity, and psychosocial functioning were assessed. The women significantly increased their physical activity (+39.6%) and cardiorespiratory fitness (+13.5%) and reduced their body weight (-6.5%), fat mass (-7.4%), body fat (-2.4%), BP (SBP -6.2%, DBP -9.2%), total cholesterol (-7.4%), triglycerides (-16.5%), and low-density lipoprotein (LDL) cholesterol (9.1%) and improved their diet (p < 0.05). At the 1-year follow-up, women had regained approximately 63% of their posttreatment weight loss (p < 0.05), but had maintained their previous increases in physical activity. Additionally, there were no significant changes in fat free mass, body fat, anxiety, or depression between the end of treatment and 1-year posttreatment. The addition of self-control skills training did not significantly improve cardiovascular risk reduction. Lifestyle change interventions may be an effective means for reducing cardiovascular risk in obese, sedentary, postmenopausal women. However, greater attention should be devoted to the maintenance of these positive lifestyle changes.

 




Moms in motion: a group-mediated cognitive-behavioral physical activity intervention.

Anita Cramp, Lawrence Brawley

The international journal of behavioral nutrition and physical activity [3:23] (2006)

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When examining the prevalence of physical inactivity by gender and age, women over the age of 25 are at an increased risk for sedentary behavior. Childbearing and motherhood have been explored as one possible explanation for this increased risk. Post natal exercise studies to date demonstrate promising physical and psychological outcomes, however few physical activity interventions have been theory-driven and tailored to post natal exercise initiates. The purpose of this study was to compare the effects of a group-mediated cognitive behavioral intervention based upon social-cognitive theory and group dynamics (GMCB) to a standard care postnatal exercise program (SE). A randomized, two-arm intervention design was used. Fifty-seven post natal women were randomized to one of two conditions: (1) a standard exercise treatment (SE) and (2) a standard exercise treatment plus group-mediated cognitive behavioral intervention (GMCB). Participants in both conditions participated in a four-week intensive phase where participants received standard exercise training. In addition, GMCB participants received self-regulatory behavioral skills training via six group-mediated counseling sessions. Following the intensive phase, participants engaged in a four-week home-based phase of self-structured exercise. Measures of physical activity, barrier efficacy, and proximal outcome expectations were administered and data were analyzed using ANCOVA procedures. ANCOVA of change scores for frequency, minutes, and volume of physical activity revealed significant treatment effects over the intensive and home-based phases (p's < 0.01). In addition, ANCOVA of change in mean barrier efficacy and proximal outcome expectations at the conclusion of the intensive phase demonstrated that GMCB participants increased their initial level of barrier efficacy and outcome expectations while SE participants decreased (p < 0.05). While both exercise programs resulted in improvements to exercise participation, the GMCB intervention produced greater improvement in overall physical activity, barrier efficacy and proximal outcome expectations.

 


What do targeting positive views on ageing add to a physical activity intervention in older adults? Results from a randomised controlled trial.

Julia Wolff, Lisa Warner, Jochen Ziegelmann, Susanne Wurm

Psychology & health [29:915-32] (2014)

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Physical activity is a key factor for healthy ageing, yet many older people lead a sedentary lifestyle. Traditional physical activity interventions do not consider the specific needs and views of older adults. As views on ageing are known to be related to health behaviours, the current study evaluates the effectiveness of prompting positive views on ageing within a physical activity intervention. Randomised controlled trial with three groups aged 65+: Intervention for physical activity with 'views-on-ageing'-component (n = 101; IGVoA), and without 'views-on-ageing'-component (n = 30; IG), and active control intervention for volunteering (n = 103; CG). Attitudes towards older adults and physical activity were assessed five weeks before intervention, two weeks, six weeks and 8.5 months after the intervention. Compared to the IG and CG, positive attitudes towards older adults increased in the IGVoA after the intervention. For IGVoA, the indirect intervention effect on change in activity via change in attitudes towards older adults was reliable. A 'views-on-ageing'-component within a physical activity intervention affects change in physical activity via change in views on ageing. Views on ageing are a promising intervention technique to be incorporated into future physical activity interventions for older adults.

 


A web-based program improves physical activity outcomes in a primary care angina population: randomized controlled trial.

R Devi, J Powell, S Singh

Journal of medical Internet research [16:e186] (2014)

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Angina affects more than 50 million people worldwide. Secondary prevention interventions such as cardiac rehabilitation are not widely available for this population. An Internet-based version could offer a feasible alternative. Our aim was to examine the effectiveness of a Web-based cardiac rehabilitation program for those with angina. We conducted a randomized controlled trial, recruiting those diagnosed with angina from general practitioners (GPs) in primary care to an intervention or control group. Intervention group participants were offered a 6-week Web-based rehabilitation program ("ActivateYourHeart"). The program was introduced during a face-to-face appointment and then delivered via the Internet (no further face-to-face contact). The program contained information about the secondary prevention of coronary heart disease (CHD) and set each user goals around physical activity, diet, managing emotions, and smoking. Performance against goals was reviewed throughout the program and goals were then reset/modified. Participants completed an online exercise diary and communicated with rehabilitation specialists through an email link/synchronized chat room. Participants in the control group continued with GP treatment as usual, which consisted of being placed on a CHD register and attending an annual review. Outcomes were measured at 6-week and 6-month follow-ups during face-to-face assessments. The primary outcome measure was change in daily steps at 6 weeks, measured using an accelerometer. Secondary outcome measures were energy expenditure (EE), duration of sedentary activity (DSA), duration of moderate activity (DMA), weight, diastolic/systolic blood pressure, and body fat percentage. Self-assessed questionnaire outcomes included fat/fiber intake, anxiety/depression, self-efficacy, and quality of life (QOL). A total of 94 participants were recruited and randomized to the intervention (n=48) or the usual care (n=46) group; 84 and 73 participants completed the 6-week and 6-month follow-ups, respectively. The mean number of log-ins to the program was 18.68 (SD 13.13, range 1-51), an average of 3 log-ins per week per participant. Change in daily steps walked at the 6-week follow-up was +497 (SD 2171) in the intervention group and -861 (SD 2534) in the control group (95% CI 263-2451, P=.02). Significant intervention effects were observed at the 6-week follow-up in EE (+43.94 kcal, 95% CI 43.93-309.98, P=.01), DSA (-7.79 minutes, 95% CI -55.01 to -7.01, P=.01), DMA (+6.31 minutes, 95% CI 6.01-51.20, P=.01), weight (-0.56 kg, 95% CI -1.78 to -0.15, P=.02), self-efficacy (95% CI 0.30-4.79, P=.03), emotional QOL score (95% CI 0.01-0.54, P=.04), and angina frequency (95% CI 8.57-35.05, P=.002). Significant benefits in angina frequency (95% CI 1.89-29.41, P=.02) and social QOL score (95% CI 0.05-0.54, P=.02) were also observed at the 6-month follow-up. An Internet-based secondary prevention intervention could be offered to those with angina. A larger pragmatic trial is required to provide definitive evidence of effectiveness and cost-effectiveness.

 




A web-based intervention for health professionals and patients to decrease cardiovascular risk attributable to physical inactivity: development process.

Barbara Sassen, Gerjo Kok, Ilse Mesters, Rik Crutzen, Anita Cremers, Luc Vanhees

JMIR research protocols [1:e21] (2012)

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Patients with cardiovascular risk factors can reduce their risk of cardiovascular disease by increasing their physical activity and their physical fitness. According to the guidelines for cardiovascular risk management, health professionals should encourage their patients to engage in physical activity. In this paper, we provide insight regarding the systematic development of a Web-based intervention for both health professionals and patients with cardiovascular risk factors using the development method Intervention Mapping. The different steps of Intervention Mapping are described to open up the "black box" of Web-based intervention development and to support future Web-based intervention development. The development of the Professional and Patient Intention and Behavior Intervention (PIB2 intervention) was initiated with a needs assessment for both health professionals (ie, physiotherapy and nursing) and their patients. We formulated performance and change objectives and, subsequently, theory- and evidence-based intervention methods and strategies were selected that were thought to affect the intention and behavior of health professionals and patients. The rationale of the intervention was based on different behavioral change methods that allowed us to describe the scope and sequence of the intervention and produced the Web-based intervention components. The Web-based intervention consisted of 5 modules, including individualized messages and self-completion forms, and charts and tables. The systematic and planned development of the PIB2 intervention resulted in an Internet-delivered behavior change intervention. The intervention was not developed as a substitute for face-to-face contact between professionals and patients, but as an application to complement and optimize health services. The focus of the Web-based intervention was to extend professional behavior of health care professionals, as well as to improve the risk-reduction behavior of patients with cardiovascular risk factors. The Intervention Mapping protocol provided a systematic method for developing the intervention and each intervention design choice was carefully thought-out and justified. Although it was not a rapid or an easy method for developing an intervention, the protocol guided and directed the development process. The application of evidence-based behavior change methods used in our intervention offers insight regarding how an intervention may change intention and health behavior. The Web-based intervention appeared feasible and was implemented. Further research will test the effectiveness of the PIB2 intervention. Dutch Trial Register, Trial ID: ECP-92.

 


Behaviour change interventions to promote physical activity in rheumatoid arthritis: a systematic review.

Louise Larkin, Stephen Gallagher, Fiona Cramp, Charles Brand, Alexander Fraser, Norelee Kennedy

Rheumatology international [35:1631-40] (2015)

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Research has shown that people who have rheumatoid arthritis (RA) do not usually participate in enough physical activity to obtain the benefits of optimal physical activity levels, including quality of life, aerobic fitness and disease-related characteristics. Behaviour change theory underpins the promotion of physical activity. The aim of this systematic review was to explore behaviour change interventions which targeted physical activity behaviour in people who have RA, focusing on the theory underpinning the interventions and the behaviour change techniques utilised using specific behaviour change taxonomy. An electronic database search was conducted via EBSCOhost, PubMed, Cochrane Central Register of Controlled Trials and Web of Science databases in August 2014, using Medical Subject Headings and keywords. A manual search of reference lists was also conducted. Randomised control trials which used behaviour change techniques and targeted physical activity behaviour in adults who have RA were included. Two reviewers independently screened studies for inclusion. Methodological quality was assessed using the Cochrane risk of bias tool. Five studies with 784 participants were included in the review. Methodological quality of the studies was mixed. The studies consisted of behaviour change interventions or combined practical physical activity and behaviour change interventions and utilised a large variety of behaviour change techniques. Four studies reported increased physical activity behaviour. All studies used subjective methods of assessing physical activity with only one study utilising an objective measure. There has been varied success of behaviour change interventions in promoting physical activity behaviour in people who have RA. Further studies are required to develop and implement the optimal behaviour change intervention in this population.

 


Testing the Senior Exercise Self-efficacy Project (SESEP) for use with urban dwelling minority older adults.

Barbara Resnick, Daria Luisi, Amanda Vogel

Public health nursing (Boston, Mass.) [25:221-34] ()

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To test the feasibility and effectiveness of the Senior Exercise Self-efficacy Project (SESEP). A feasibility study using a randomized control trial. The total sample included 166 persons, with a mean age of 73 years (SD=8.2 years), the majority of whom were female (81%), African American (72%), unmarried (86%), had at least a high school education (64%), and were retired (77%). There were 100 participants in the intervention group and 66 in the comparison group. The SESEP was a combined physical activity and efficacy-enhancing intervention for community-dwelling minority older adults. The primary outcomes included self-efficacy, outcome expectations, exercise, and overall physical activity, and the secondary outcomes were mental and physical health-related quality of life, depressive symptoms, pain, fear of falling, mobility, and chair rise time. Data were collected at baseline and following the 12-week intervention. There were statistically significant improvements in outcome expectations (p=.02), time spent in exercise (p=.04), and depressive symptoms (p=.02). Overall, there was a 77% rate of participation in classes. Although there was good participation in the SESEP among minority older adults, the primary outcomes were only minimally supported and there was even less support for the secondary outcomes.

 


A pilot study evaluating a peer led and professional led physical activity intervention with blue-collar employees.

Russ Elbel, Steve Aldana, Don Bloswick, Joseph Lyon

Work (Reading, Mass.) [21:199-210] (2003)

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To measure the effect of a physical activity intervention, based on social cognitive theory, delivered by a peer and a professional leader. Quasi-experimental. Three locations at a large Mid-Western railroad. One hundred and forty-eight skilled labor employees participated: one hundred and twenty completed the study. Self-reported energy expenditure, self-efficacy and stages of change. ANOVA and categorical analysis using rates and proportions were used for evaluation. The peer group had a non-significant short-term increase in energy expenditure of 3%, which returned to baseline post intervention. The professional and control groups showed a non-significant decrease in energy expenditure of 5% and 9%, respectively. The peer (p < 0.002) and professional groups (p < 0.004) showed significant increases in average stages scores. The peer group maintained increases over time (p < 0.001). The peer and professional led groups showed a 54% and 24% increase in the number of employees reporting regular physical activity over time, respectively. The peer group also showed positive trends in self-efficacy. The peer intervention enhanced self-efficacy and self-reported physical activity. A job layoff at the professional led site confounded comparisons between locations. Employees reported high energy expenditure and high BMI values, suggesting that a weight management intervention may be more appropriate and appealing in this population.

 


A Smartphone App to Promote an Active Lifestyle in Lower-Educated Working Young Adults: Development, Usability, Acceptability, and Feasibility Study.

Dorien Simons, Ilse De Bourdeaudhuij, Peter Clarys, Katrien De Cocker, Corneel Vandelanotte, Benedicte Deforche

JMIR mHealth and uHealth [6:e44] (2018)

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Physical activity (PA) levels are problematic in lower-educated working young adults (18-26 years). To promote PA, smartphone apps have great potential, but there is no evidence for their effectiveness in this population. To increase the likelihood that a newly developed app will be effective, formative research and user testing are required. The aim of this study was to describe the development, usability, acceptability, and feasibility of a new theory- and evidence-based smartphone app to promote an active lifestyle in lower-educated working young adults. The new app was developed by applying 4 steps. First, determinants important to promote an active lifestyle in this population were selected. Second, evidence-based behavior change techniques were selected to convert the determinants into practical applications. Third, a new smartphone app was developed. Fourth, volunteers (n=11, both lower and higher educated) tested the app on usability, and lower-educated working young adults (n=16) tested its acceptability and feasibility via (think aloud) interviews, a questionnaire, and Google Analytics. The app was accordingly adapted for the final version. A new Android app, Active Coach, was developed that focused on knowledge, attitude, social support, and self-efficacy (based on outcomes from step 1), and that applied self-regulation techniques (based on outcomes from step 2). The app consists of a 9-week program with personal goals, practical tips, and scientific facts to encourage an active lifestyle. To ensure all-day and automatic self-monitoring of the activity behavior, the Active Coach app works in combination with a wearable activity tracker, the Fitbit Charge. Issues detected by the usability test (eg, text errors, wrong messages) were all fixed. The acceptability and feasibility test showed that participants found the app clear, understandable, and motivating, although some aspects needed to be more personal. By applying a stepwise, user-centered approach that regularly consulted the target group, the new app is adapted to their specific needs and preferences. The Active Coach app was overall positively evaluated by the lower-educated working young adults at the end of the development process.

 


The effectiveness of interventions aimed at increasing physical activity in adults with persistent musculoskeletal pain: a systematic review and meta-analysis.

Joanne Marley, Mark Tully, Alison Porter-Armstrong, Brendan Bunting, John O'Hanlon, Lou Atkins, Sarah Howes, Suzanne McDonough

BMC musculoskeletal disorders [18:482] (2017)

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Individuals with persistent musculoskeletal pain (PMP) have an increased risk of developing co-morbid health conditions and for early-mortality compared to those without pain. Despite irrefutable evidence supporting the role of physical activity in reducing these risks; there has been limited synthesis of the evidence, potentially impacting the optimisation of these forms of interventions. This review examines the effectiveness of interventions in improving levels of physical activity and the components of these interventions. Randomised and quasi-randomised controlled trials were included in this review. The following databases were searched from inception to March 2016: CENTRAL in the Cochrane Library, Cochrane Database of Systematic Reviews (CDSR), MEDLINE, Embase, CINAHL, PsycINFO and AMED. Two reviewers independently screened citations, assessed eligibility, extracted data, assessed risk of bias and coded intervention content using the behaviour change taxonomy (BCTTv1) of 93 hierarchically clustered techniques. GRADE was used to rate the quality of the evidence. The full text of 276 articles were assessed for eligibility, twenty studies involving 3441 participants were included in the review. Across the studies the mean number of BCTs coded was eight (range 0-16); with 'goal setting' and 'instruction on how to perform the behaviour' most frequently coded. For measures of subjective physical activity: interventions were ineffective in the short term, based on very low quality evidence; had a small effect in the medium term based on low quality evidence (SMD 0.25, 95% CI 0.01 to 0.48) and had a small effect in the longer term (SMD 0.21 95% CI 0.08 to 0.33) based on moderate quality evidence. For measures of objective physical activity: interventions were ineffective - based on very low to low quality evidence. There is some evidence supporting the effectiveness of interventions in improving subjectively measured physical activity however, the evidence is mostly based on low quality studies and the effects are small. Given the quality of the evidence, further research is likely/very likely to have an important impact on our confidence in effect estimates and is likely to change the estimates. Future studies should provide details on intervention components and incorporate objective measures of physical activity.

 


How effective is community physical activity promotion in areas of deprivation for inactive adults with cardiovascular disease risk and/or mental health concerns? Study protocol for a pragmatic observational evaluation of the 'Active Herts' physical activity programme.

Neil Howlett, Andy Jones, Lucy Bain, Angel Chater

BMJ open [7:e017783] (2017)

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There is a high prevalence of inactive adults in the UK, and many suffer from conditions such as cardiovascular disease (CVD) or poor mental health. These coexist more frequently in areas of higher socioeconomic deprivation. There is a need to test the effectiveness, acceptability and sustainability of physical activity programmes. Active Herts uses novel evidence-based behaviour change techniques to target physical inactivity. Active Herts is a community physical activity programme for inactive adults aged 16+ with one or more risk factors for CVD and/or a mild to moderate mental health condition. This evaluation will follow a mixed-methods longitudinal (baseline, and 3-month, 6-month and 12-month follow-ups) design. Pragmatic considerations mean delivery of the programme differs by locality. In two areas programme users will receive a behaviour change technique booklet, regular consultations, a booster phone call, motivational text messages and signposting to 12 weeks of exercise classes. In another two areas programme users will also receive 12 weeks of free tailored exercise classes, with optional exercise 'buddies' available. An outcome evaluation will assess changes in physical activity as the primary outcome, and sporting participation, sitting, well-being, psychological capability and reflective motivation as secondary outcomes. A process evaluation will explore the views of stakeholders, delivery staff and programme leads. Economic evaluation will examine the programme costs against the benefits gained in terms of reduced risk of morbidity. This study was been approved by the Faculty of Medicine and Health Sciences Research Ethics Committee at the University of East Anglia. Informed written consent will be obtained from programme users in the evaluation. Results will be published in peer-reviewed journals, presented at conferences, and shared through the study website and local community outlets. ClinicalTrials.gov ID number: NCT03153098.

 



Sensing interstitial glucose to nudge active lifestyles (SIGNAL): feasibility of combining novel self-monitoring technologies for persuasive behaviour change.

Maxine Whelan, Andrew Kingsnorth, Mark Orme, Lauren Sherar, Dale Esliger

BMJ open [7:e018282] (2017)

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Increasing physical activity (PA) reduces the risk of developing diabetes, highlighting the role of preventive medicine approaches. Changing lifestyle behaviours is difficult and is often predicated on the assumption that individuals are willing to change their lifestyles today to reduce the risk of developing disease years or even decades later. The self-monitoring technologies tested in this study will present PA feedback in real time, parallel with acute physiological data. Presenting the immediate health benefits of being more physically active may help enact change by observing the immediate consequences of that behaviour. The present study aims to assess user engagement with the self-monitoring technologies in individuals at moderate-to-high risk of developing type 2 diabetes. 45 individuals with a moderate-to-high risk, aged ≥40 years old and using a compatible smartphone, will be invited to take part in a 7-week protocol. Following 1 week of baseline measurements, participants will be randomised into one of three groups: group 1- glucose feedback followed by biobehavioural feedback (glucose plus PA); group 2-PA feedback followed by biobehavioural feedback; group 3-biobehavioural feedback. A PA monitor and a flash glucose monitor will be deployed during the intervention. Participants will wear both devices throughout the intervention but blinded to feedback depending on group allocation. The primary outcome is the level of participant engagement and will be assessed by device use and smartphone usage. Feasibility will be assessed by the practicality of the technology and screening for diabetes risk. Semistructured interviews will be conducted to explore participant experiences using the technologies. ISRCTN17545949. Registered on 15/05/2017.

 


Targeting motivation and self-regulation to increase physical activity among patients with rheumatoid arthritis: a randomised controlled trial.

Keegan Knittle, Veronique De Gucht, Emalie Hurkmans, Andre Peeters, Karel Ronday, Stan Maes, Thea Vliet Vlieland

Clinical rheumatology [34:231-8] (2015)

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The purpose of this study is to evaluate the effects of targeting both the motivation and action phases of behaviour change in a 5-week intervention to increase physical activity (PA) among patients with rheumatoid arthritis (RA) not meeting current PA recommendations. In a randomised controlled trial, a control group—which received a group-based patient education session led by a physical therapist—was compared to a treatment group which received the education session plus a motivational interview from a physical therapist and two self-regulation coaching sessions from a rheumatology nurse. Outcomes included leisure-time PA, days per week with at least 30 min of moderate-intensity PA, self-efficacy and autonomous motivation (cognitions which predict PA initiation and maintenance), disease activity, functional status, depressive symptoms and fatigue. Effects were assessed using mixed models repeated measures. Of the 78 patients randomised, 76 and 67 completed the post-treatment and follow-up assessments, respectively. Significant treatment effects were found for leisure-time PA (p = 0.022), active days/week (p = 0.016), self-efficacy (p = 0.008) and autonomous motivation (p = 0.001). At post-treatment and 6-months follow-up, significantly more treated patients than controls met current PA recommendations. No significant effects were found for disease activity, functional status, depressive symptoms or fatigue. Combining motivation- and action-focused intervention approaches improved PA-related cognitions and led to improved uptake and maintenance of leisure-time PA. However, further research is necessary to identify ways of helping patients with RA transition to—and maintain—more intensive forms of PA which are more likely to improve disease activity and functional status.

 


Healthy habits: efficacy of simple advice on weight control based on a habit-formation model.

P Lally, A Chipperfield, J Wardle

International journal of obesity (2005) [32:700-7] (2008)

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To evaluate the efficacy of a simple weight loss intervention, based on principles of habit formation. An exploratory trial in which overweight and obese adults were randomized either to a habit-based intervention condition (with two subgroups given weekly vs monthly weighing; n=33, n=36) or to a waiting-list control condition (n=35) over 8 weeks. Intervention participants were followed up for 8 months. A total of 104 adults (35 men, 69 women) with an average BMI of 30.9 kg m(-2). Intervention participants were given a leaflet containing advice on habit formation and simple recommendations for eating and activity behaviours promoting negative energy balance, together with a self-monitoring checklist. Weight change over 8 weeks in the intervention condition compared with the control condition and weight loss maintenance over 32 weeks in the intervention condition. At 8 weeks, people in the intervention condition had lost significantly more weight (mean=2.0 kg) than those in the control condition (0.4 kg), with no difference between weekly and monthly weighing subgroups. At 32 weeks, those who remained in the study had lost an average of 3.8 kg, with 54% losing 5% or more of their body weight. An intention-to-treat analysis (based on last-observation-carried-forward) reduced this to 2.6 kg, with 26% achieving a 5% weight loss. This easily disseminable, low-cost, simple intervention produced clinically significant weight loss. In limited resource settings it has potential as a tool for obesity management.

 


Development of a fully automated, web-based, tailored intervention promoting regular physical activity among insufficiently active adults with type 2 diabetes: integrating the I-change model, self-determination theory, and motivational interviewing components.

Michel Moreau, Marie-Pierre Gagnon, François Boudreau

JMIR research protocols [4:e25] (2015)

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Type 2 diabetes is a major challenge for Canadian public health authorities, and regular physical activity is a key factor in the management of this disease. Given that fewer than half of people with type 2 diabetes in Canada are sufficiently active to meet the recommendations, effective programs targeting the adoption of regular physical activity (PA) are in demand for this population. Many researchers argue that Web-based, tailored interventions targeting PA are a promising and effective avenue for sedentary populations like Canadians with type 2 diabetes, but few have described the detailed development of this kind of intervention. This paper aims to describe the systematic development of the Web-based, tailored intervention, Diabète en Forme, promoting regular aerobic PA among adult Canadian francophones with type 2 diabetes. This paper can be used as a reference for health professionals interested in developing similar interventions. We also explored the integration of theoretical components derived from the I-Change Model, Self-Determination Theory, and Motivational Interviewing, which is a potential path for enhancing the effectiveness of tailored interventions on PA adoption and maintenance. The intervention development was based on the program-planning model for tailored interventions of Kreuter et al. An additional step was added to the model to evaluate the intervention's usability prior to the implementation phase. An 8-week intervention was developed. The key components of the intervention include a self-monitoring tool for PA behavior, a weekly action planning tool, and eight tailored motivational sessions based on attitude, self-efficacy, intention, type of motivation, PA behavior, and other constructs and techniques. Usability evaluation, a step added to the program-planning model, helped to make several improvements to the intervention prior to the implementation phase. The intervention development cost was about CDN $59,700 and took approximately 54 full-time weeks. The intervention officially started on September 29, 2014. Out of 2300 potential participants targeted for the tailored intervention, approximately 530 people visited the website, 170 people completed the registration process, and 83 corresponded to the selection criteria and were enrolled in the intervention. Usability evaluation is an essential step in the development of a Web-based tailored intervention in order to make pre-implementation improvements. The effectiveness and relevance of the theoretical framework used for the intervention will be analyzed following the process and impact evaluation. Implications for future research are discussed.

 


The systematic development of a brief intervention to increase walking in the general public using an "extended theory of planned behavior.

David French, Catherine Darker, Frank Eves, Falko Sniehotta

Journal of physical activity & health [10:940-8] (2013)

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The Theory of Planned Behavior (TPB) has been extensively used in predictive studies, but there have been considerably fewer experimental tests of the theory. One reason for this is that the guidance on developing concrete intervention strategies from the abstract theory is vague, and there are few exemplars of how to do this. The aim of this article is to provide such an exemplar. The development of an intervention to increase walking in the general public is described, based on the TPB, extended to include postvolitional processes. Identification of target constructs, elicitation of key salient beliefs underpinning these constructs, selection of appropriate behavior change techniques, and technique refinement. Each step is based on available evidence and consistent with theory. Perceived behavioral control (PBC) was identified as the key determinant of walking intentions, with an "intention-behavior gap" noted. A brief intervention was developed, using techniques to increase PBC by rehearsal of previous successful performance of behavior, along with planning techniques to translate motivation into behavior. This systematic approach taken should provide a model for others. The intervention has demonstrated efficacy in producing large changes in objectively measured walking behavior, in 2 separate evaluations reported elsewhere.

 


An mHealth Intervention Using a Smartphone App to Increase Walking Behavior in Young Adults: A Pilot Study.

Jane Walsh, Teresa Corbett, Michael Hogan, Jim Duggan, Abra McNamara

JMIR mHealth and uHealth [4:e109] (2016)

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Physical inactivity is a growing concern for society and is a risk factor for cardiovascular disease, obesity, and other chronic diseases. This study aimed to determine the efficacy of the Accupedo-Pro Pedometer mobile phone app intervention, with the goal of increasing daily step counts in young adults. Mobile phone users (n=58) between 17-26 years of age were randomized to one of two conditions (experimental and control). Both groups downloaded an app that recorded their daily step counts. Baseline data were recorded and followed-up at 5 weeks. Both groups were given a daily walking goal of 30 minutes, but the experimental group participants were told the equivalent goal in steps taken, via feedback from the app. The primary outcome was daily step count between baseline and follow-up. A significant time x group interaction effect was observed for daily step counts (P=.04). Both the experimental (P<.001) and control group (P=.03) demonstrated a significant increase in daily step counts, with the experimental group walking an additional 2000 steps per day. The results of this study demonstrate that a mobile phone app can significantly increase physical activity in a young adult sample by setting specific goals, using self-monitoring, and feedback.

 




Testing Activity Monitors' Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients.

Zakkoyya Lewis, Kenneth Ottenbacher, Steve Fisher, Kristofer Jennings, Arleen Brown, Maria Swartz, Elizabeth Lyons

JMIR research protocols [5:e59] (2016)

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Cardiovascular disease is the leading cause of mortality in the United States. Maintaining healthy levels of physical activity is critical to cardiovascular health, but many older adults are inactive. There is a growing body of evidence linking low motivation and inactivity. Standard behavioral counseling techniques used within the primary care setting strive to increase motivation, but often do not emphasize the key component of self-control. The addition of electronic activity monitors (EAMs) to counseling protocols may provide more effective behavior change and increase overall motivation for exercise through interactive self-monitoring, feedback, and social support from other users. The objective of the study is to conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (n=40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Throughout the intervention, we will test its feasibility and acceptability, the change in primary outcomes (cardiovascular risk and physical activity), and the change in secondary outcomes (adherence, weight and body composition, health status, motivation, physical function, psychological feelings, and self-regulation). Upon completion of the intervention, we will also conduct focus groups with the participants and with primary care stakeholders. The study started recruitment in October 2015 and is scheduled to be completed by October 2016. This project will lay the groundwork and establish the infrastructure for intervention refinement and ultimately translation within the primary care setting in order to prevent cardiovascular disease on a population level. ClinicalTrials.gov NCT02554435; https://clinicaltrials.gov/ct2/show/NCT02554435 (Archived by WebCite at http://www.webcitation/6fUlW5tdT).

 


Secondary prevention lifestyle interventions initiated within 90 days after TIA or 'minor' stroke: a systematic review and meta-analysis of rehabilitation programmes.

Neil Heron, Frank Kee, Christopher Cardwell, Mark Tully, Michael Donnelly, Margaret Cupples

The British journal of general practice : the journal of the Royal College of General Practitioners [67:e57-e66] (2017)

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Strokes are often preceded by a transient ischaemic attack (TIA) or 'minor' stroke. The immediate period after a TIA/minor stroke is a crucial time to initiate secondary prevention. However, the optimal approach to prevention, including non-pharmacological measures, after TIA is not clear. To systematically review evidence about the effectiveness of delivering secondary prevention, with lifestyle interventions, in comprehensive rehabilitation programmes, initiated within 90 days of a TIA/minor stroke. Also, to categorise the specific behaviour change techniques used. The review identified randomised controlled trials by searching the Cochrane Library, Ovid MEDLINE, Ovid EMBASE, Web of Science, EBSCO CINAHL and Ovid PsycINFO. Two review authors independently screened titles and abstracts for eligibility (programmes initiated within 90 days of event; outcomes reported for TIA/minor stroke) and extracted relevant data from appraised studies; a meta-analysis was used to synthesise the results. A total of 31 potentially eligible papers were identified and four studies, comprising 774 patients post-TIA or minor stroke, met the inclusion criteria; two had poor methodological quality. Individual studies reported increased aerobic capacity but meta-analysis found no significant change in resting and peak systolic blood pressure, resting heart rate, aerobic capacity, falls, or mortality. The main behaviour change techniques were goal setting and instructions about how to perform given behaviours. There is limited evidence of the effectiveness of early post-TIA rehabilitation programmes with preventive lifestyle interventions. Further robust randomised controlled trials of comprehensive rehabilitation programmes that promote secondary prevention and lifestyle modification immediately after a TIA are needed.

 



Evaluation of CHAMPS, a physical activity promotion program for older adults.

A Stewart, K Mills, P Sepsis, A King, B McLellan, K Roitz, P Ritter

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine [19:353-61] (1997)

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We evaluated physical activity changes resulting from a six-month public health model intervention that encouraged seniors (N = 89) 62-91 years of age (mean = 76) living in two low-income congregate housing facilities to increase their physical activity by participating in existing community-based physical activity classes and programs of their choice. The program was offered to everyone regardless of their health problems. Enrollees were encouraged to adopt activities tailored to their preferences, physical abilities, health status, income, and transportation resources. Using a comparison-group design, the intervention group was more active for all comparison months of the intervention period (p values < .05). The intervention also was associated with improvements in self-esteem (p < .05), though not with an array of other measures of health-related quality-of-life. Those who adopted and maintained a new physical activity over the six-month intervention period experienced improvements in anxiety, depression, and overall psychological well-being relative to those who did not. The intervention was subsequently replicated through a senior center (N = 22). A much larger proportion of the senior center sample adopted and maintained a new activity for six months (68%) compared to the congregate facilities sample (35%), which may have been due to differences in recruitment methods and sample characteristics in the two settings. An intervention promoting increased physical activity through the use of existing community resources may help increase physical activity in older adults.

 


Colon cancer information as a source of exercise motivation for relatives of patients with colon cancer.

Erin McGowan, Harry Prapavessis

Psychology, health & medicine [15:729-41] (2010)

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Using a Protection Motivation Theory (PMT) framework, this study examined whether factual colon cancer information is a meaningful source of exercise motivation for relatives of patients with colon cancer. One hundred sixty-six inactive relatives were randomly assigned to one of two treatment conditions: PMT group (intervention); and non-PMT group (attention control). At baseline (T1) participants completed demographic information, a questionnaire designed to assess their beliefs toward exercise and colon cancer as well as their exercise intentions. At T2 (one week following T1) participants watched one of two DVD videos that were created for the study. The intervention DVD contained exercise and colon cancer information that was yoked within the four major components of PMT: perceived vulnerability (PV); perceived severity (PS); response efficacy (RE); and self-efficacy (SE), while the attention control DVD contained general diet and cancer information. Immediately following watching the DVD, participants completed the same measures as in T1. Participants assigned to the PMT intervention group showed significant improvement in PV, RE, SE and exercise intentions, whereas participants assigned to the attention control group showed significant improvement only in RE. RE, SE, and PS made significant and unique contributions to prediction of exercise intention. Overall, the results of the present study demonstrate that a single exposure media intervention grounded in a PMT framework can change individuals' exercise and colon cancer beliefs, as well as change their exercise intentions. Implications of these findings and direction for future research are discussed.

 


Wearable Activity Tracker Use Among Australian Adolescents: Usability and Acceptability Study.

Nicola Ridgers, Anna Timperio, Helen Brown, Kylie Ball, Susie Macfarlane, Samuel Lai, Kara Richards, Kelly Mackintosh, Melitta McNarry, Megan Foster, Jo Salmon

JMIR mHealth and uHealth [6:e86] (2018)

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Wearable activity trackers have the potential to be integrated into physical activity interventions, yet little is known about how adolescents use these devices or perceive their acceptability. The aim of this study was to examine the usability and acceptability of a wearable activity tracker among adolescents. A secondary aim was to determine adolescents' awareness and use of the different functions and features in the wearable activity tracker and accompanying app. Sixty adolescents (aged 13-14 years) in year 8 from 3 secondary schools in Melbourne, Australia, were provided with a wrist-worn Fitbit Flex and accompanying app, and were asked to use it for 6 weeks. Demographic data (age, sex) were collected via a Web-based survey completed during week 1 of the study. At the conclusion of the 6-week period, all adolescents participated in focus groups that explored their perceptions of the usability and acceptability of the Fitbit Flex, accompanying app, and Web-based Fitbit profile. Qualitative data were analyzed using pen profiles, which were constructed from verbatim transcripts. Adolescents typically found the Fitbit Flex easy to use for activity tracking, though greater difficulties were reported for monitoring sleep. The Fitbit Flex was perceived to be useful for tracking daily activities, and adolescents used a range of features and functions available through the device and the app. Barriers to use included the comfort and design of the Fitbit Flex, a lack of specific feedback about activity levels, and the inability to wear the wearable activity tracker for water-based sports. Adolescents reported that the Fitbit Flex was easy to use and that it was a useful tool for tracking daily activities. A number of functions and features were used, including the device's visual display to track and self-monitor activity, goal-setting in the accompanying app, and undertaking challenges against friends. However, several barriers to use were identified, which may impact on sustained use over time. Overall, wearable activity trackers have the potential to be integrated into physical activity interventions targeted at adolescents, but both the functionality and wearability of the monitor should be considered.

 


Protocol for the 'Virtual Traveller' cluster-randomised controlled trial: a behaviour change intervention to increase physical activity in primary-school Maths and English lessons.

E Norris, S Dunsmuir, O Duke-Williams, E Stamatakis, N Shelton

BMJ open [6:e011982] (2016)

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Physical activity (PA) has been shown to be an important factor for health and educational outcomes in children. However, a large proportion of children's school day is spent in sedentary lesson-time. There is emerging evidence about the effectiveness of physically active lessons: integrating physical movements and educational content in the classroom. 'Virtual Traveller' is a novel 6-week intervention of 10-min sessions performed 3 days per week, using classroom interactive whiteboards to integrate movement into primary-school Maths and English teaching. The primary aim of this project is to evaluate the effect of the Virtual Traveller intervention on children's PA, on-task behaviour and student engagement. This study will be a cluster-randomised controlled trial with a waiting-list control group. Ten year 4 (aged 8-9 years) classes across 10 primary schools will be randomised by class to either the 6-week Virtual Traveller intervention or the waiting-list control group. Data will be collected 5 times: at baseline, at weeks 2 and 4 of the intervention, and 1 week and 3 months postintervention. At baseline, anthropometric measures, 4-day objective PA monitoring (including 2 weekend days; Actigraph accelerometer), PA and on-task behaviour observations and student engagement questionnaires will be performed. All but anthropometric measures will be repeated at all other data collection points. Changes in overall PA levels and levels during different time-periods (eg, lesson-time) will be examined. Changes in on-task behaviour and student engagement between intervention groups will also be examined. Multilevel regression modelling will be used to analyse the data. Process evaluation will be carried out during the intervention period. The results of this study will be disseminated through peer-review publications and conference presentations. Ethical approval was obtained through the University College London Research Ethics Committee (reference number: 3500-004).

 


The Effect of the Move More Pack on the Physical Activity of Cancer Survivors: Protocol for a Randomized Waiting List Control Trial with Process Evaluation.

Justin Webb, Chris Fife-Schaw, Jane Ogden, Jo Foster

JMIR research protocols [6:e220] (2017)

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Physical activity can improve many common side effects of cancer treatment as well as improve physical function and quality of life (QOL). In addition, physical activity can improve survival rate and reduce cancer recurrence. Despite these benefits, only 23% of cancer survivors in England are active to recommended levels. Cancer survivors are interested in lifestyle behavior change. Home-based interventions offer a promising means for changing physical activity behavior. Prediagnosis levels of physical activity and self-efficacy have been reported to be predictors of physical activity behavior change. The Move More Pack, which has undergone revision, is a printed resource with supporting Internet-based tools that aims to increase the physical activity of cancer survivors in the United Kingdom. The revised Move More Pack is underpinned by the theory of planned behavior and the social cognitive theory. The aim of this proposed study was to investigate the effect of the revised Move More Pack, supported by Internet-based tools, on physical activity, self-efficacy, and health-related QOL (HRQOL) of cancer survivors in the United Kingdom. This study is a two-arm waiting list randomized control trial with embedded process evaluation. A sample of 99 participants per arm will be recruited by invitation through an email database of cancer survivors held by UK charity Macmillan Cancer Support and an advert placed on the Macmillan Cancer Support Facebook page. Each participant is randomized to receive brief physical activity information and the UK guidelines for physical activity, or brief physical activity information and the revised Move More Pack with supporting Internet-based tools. The intervention and control arm will be followed up at 12 weeks to identify changes in self-reported physical activity, self-efficacy, and HRQOL based on Web-based questionnaires. The control arm will receive the revised Move More Pack at 12 weeks with follow-up at 24 weeks. The intervention arm is followed up at 24 weeks to determine maintenance of reported changes. Subgroup analyses will be completed based on participants' prediagnosis level of physical activity and baseline self-efficacy as possible predictors of positive changes. Use of each component of the revised Move More Pack will be assessed using a 4-point Likert scale. Semistructured phone interviews will evaluate the use and perceived usefulness of the revised Move More Pack. Participant recruitment started in March 2017. Projected completion of this study is October 2018. This study's findings will identify if the proposed low-cost broad reach intervention improves physical activity, self-efficacy, and the HRQOL of cancer survivors. The process evaluation is designed to contextualize the use and perceived usefulness of the revised Move More Pack, help augment its efficient distribution, and identify potential improvements to its design.

 


Effects of the Start For Life treatment on physical activity in primarily African American preschool children of ages 3-5 years.

James Annesi, Alice Smith, Gisèle Tennant

Psychology, health & medicine [18:300-9] (2013)

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In U.S. children of ages 2-5 years, combined overweight and obesity has increased to 21%, with African American children of this age range highest at 26%. Lack of physical activity is highly predictive of overweight and obesity in children. Preschools may be a useful point for intervention. An innovative preschool physical activity treatment (Start For Life) was developed based on principles of social cognitive and self-efficacy theory. It incorporated 30 minutes daily of highly structured physical activity with behavioral and self-regulatory skills training (e.g. goal setting, self-monitoring, productive self-talk) interspersed. Data obtained from accelerometry was used to contrast physical activity outputs during the preschool day in the Start For Life condition (n = 202) with a usual-care control condition (n = 136). After controlling for age and sex of the primarily African American participants (M age = 4.7 years), changes over eight weeks in moderate-to-vigorous and vigorous physical activity were significant, and significantly more favorable in the Start For Life group; F(1, 344) = 4.98, p = .026 and F(1, 344) = 3.60, p = .058, respectively. Start For Life was associated with a weekly increase in moderate-to-vigorous physical activity of approximately 40 minutes. After sufficient replications that better account for different sample types, parental effects and physical activity outside of the school day, and long-term effects, widespread dissemination may be considered.

 


A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: study protocol.

David French, Stefanie Williams, Susan Michie, Claire Taylor, Ala Szczepura, Nigel Stallard, Jeremy Dale

BMC family practice [12:56] (2011)

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The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs) and Healthcare Assistants (HCAs) to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour), and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking.The trial will recruit 20 PN/HCAs (10 per arm), who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA). This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in constructs specified by the Theory of Planned Behaviour lead to changes in objectively assessed walking behaviour. This trial addresses the current lack of evidence for interventions that are effective at increasing walking and that can be offered to patients in primary care. The intervention being evaluated has demonstrated efficacy, and has been through an extensive process of adaptation to ensure acceptability to both provider and recipient, thus optimising fidelity of intervention delivery and treatment receipt. It therefore provides a strong test of the hypothesis that a self-regulation intervention can help primary care patients increase their walking. Current Controlled Trials ISRCTN95932902.

 


Weight and behavioral and psychosocial factors among ethnically diverse, low-income women after childbirth: II. Trends and correlates.

Lorraine Walker, Jeanne Freeland-Graves, Tracey Milani, Goldy George, Henry Hanss-Nuss, Minseong Kim, Bobbie Sue Sterling, Gayle Timmerman, Susan Wilkinson, Kristopher Arheart, Alexa Stuifbergen

Women & health [40:19-34] (2004)

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This paper presents a longitudinal analysis of behavioral and psychosocial correlates of weight trends during the first postpartum year. Data are derived from the Austin New Mothers Study (ANMS), a longitudinal study of a low-income, tri-ethnic sample of postpartum women that incorporated serial assessment of weight and behavioral and psychosocial variables. Postpartum body mass index (BMI) was measured prospectively (post-delivery, 6 weeks, and 3, 6, and 12 months postpartum). The analytic sample consisted of 382 White, African American, and Hispanic women receiving maternity care funded by Medicaid who had at least three measured postpartum weights. Behavioral and psychosocial variables included energy intakes, fat intakes, physical activity, health related lifestyle, smoking, breastfeeding, contraception, depressive symptoms, emotional eating, body image, and weight-related distress. Using hierarchical linear modeling to incorporate baseline only and time-varying effects, significant associations with postpartum BMI were found for the following variables: ethnicity (p = .001), time of weight measurement (p < .001), the interaction of ethnicity and time (p = .005), pre-pregnant BMI (p < .001), gestational weight gain (p < .001), weight-related distress (p < .001), and energy intakes (p = .005). After adjusting for covariates, ethnic groups displayed differing trends in postpartum BMI resulting in White women having significantly lower BMIs at 12 months postpartum compared to ethnic minority women (p's < .01). Behavioral and psychosocial variables contribute to a fuller understanding of BMI status of low-income women during the first postpartum year.

 


The effects of a multimodal intervention trial to promote lifestyle factors associated with the prevention of cardiovascular disease in menopausal and postmenopausal Australian women.

Debra Anderson, Khadegh Mizzari, Victoria Kain, Joan Webster

Health care for women international [27:238-53] (2006)

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The purpose of this study was to test the efficacy of a multimodal intervention (Women's Wellness Program) to improve women's cardiovascular risk factors. This 12-week randomized experiment with a control group targeted women 50-65 years living in the general population. Women in the intervention group were provided with a consultation with a registered nurse at which time biophysical cardiovascular risk measures were taken and health education was provided in both verbal and written form. Women were encouraged to review their smoking, nutrition, and water intakes and to commence an exercise program that included aerobic fitness exercises. Women in the control group continued their normal activities. The sample consisted of 90 women aged 50-65 years. Pre- and post-intervention assessment utilized seven measures of cardiovascular risk factors: waist-to-hip ratio (WHR), body mass index (BMI), blood pressure, heart rate, weight, exercise levels, and smoking. Analysis of covariance indicated that the intervention was effective in improving women's aerobic exercise activity and decreasing smoking. The data from all five biophysical outcome measures supported the efficacy of the intervention, with significant decreases seen in the women's WHR, BMI, blood pressure, and measured weight. Study implications suggest that this type of intervention may provide an effective, clinically manageable therapy for women who prefer a self-directed approach to preventing and decreasing cardiovascular risk factors.

 


Self-monitoring of physical activity: effects on self-efficacy and behavior in people with type 2 diabetes.

JM Gleeson-Kreig

The Diabetes educator [32:69-77] ()

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The purpose of this study was to test the effect of keeping daily activity records on physical activity levels and self-efficacy for physical activity in adults with type 2 diabetes, and to examine the feasibility and acceptability of this intervention from the perspective of the participants. This intervention study included 58 individuals with type 2 diabetes aged 40 to 65 years. Participants were randomly assigned: individuals in the intervention group kept daily activity records for 6 weeks, mailed to the researcher every 2 weeks. Data collection was completed at the beginning of the study and 6 weeks later, using the habitual physical activity index and the self-efficacy for exercise scale. Participants in the intervention group also completed the perceived feasibility checklist. The intervention resulted in enhanced self-efficacy. Physical activity improved in both the intervention and control groups. Activity recording was judged to be acceptable and feasible. Daily activity recording can be used as part of a program to increase physical activity self-efficacy levels. Focused interactions between health care providers and patients may be enough to motivate people to higher levels of physical activity. The relationship between self-efficacy and behavior is complex and should be the subject of further research.

 


Leading the Way in Exercise and Diet (Project LEAD): intervening to improve function among older breast and prostate cancer survivors.

Wendy Demark-Wahnefried, Miriam Morey, Elizabeth Clipp, Carl Pieper, Denise Snyder, Richard Sloane, Harvey Cohen

Controlled clinical trials [24:206-23] (2003)

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The U.S. population is aging, bringing with it an increased prevalence of chronic disease and concomitant declines in physical function. The risk of developing cancer increases significantly with age, and functional decline is much more likely once a cancer diagnosis is rendered. Thus, functional status in later life is a key concern, one that is heightened among elders who have been diagnosed with cancer. To date, however, there have been few trials that have exclusively addressed issues related to cancer survivorship among older cancer patients, and to our knowledge, none has focused on preserving or enhancing physical functioning. This paper describes the study design and methodological considerations of a randomized controlled trial to determine if a personally tailored workbook and telephone counseling program can positively affect physical activity and dietary behaviors and ultimately the physical functioning of up to 420 older men and women newly diagnosed with breast or prostate cancer. This trial is unique because the cancer diagnosis is used not only as a marker of risk for functional decline, but also as a "teachable moment" - an opportune time when elders may be more receptive to making beneficial lifestyle changes. Undoubtedly, as cure rates for cancer increase and intersect with ever-growing numbers of elderly, there will be numerous opportunities to provide and test interventions within this vulnerable population and to target functional status as a primary outcome. In reporting our methods, we hope to give others "a leg up," so that they can hurdle with greater ease the barriers we experienced, and thus advance the field more rapidly.

 


Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial.

Nancy Allen, James Fain, Barry Braun, Stuart Chipkin

Diabetes research and clinical practice [80:371-9] (2008)

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Despite the known benefits, 60% of individuals with diabetes do not engage in regular physical activity (PA). This pilot study tested the effects of a counseling intervention using continuous glucose monitoring system (CGMS) feedback on PA self-efficacy, PA levels, and physiological variables. Adults (N=52) with type 2 diabetes (non-insulin requiring, inactive) were randomized to intervention (n=27) or control (n=25) groups. Both groups received 90min of diabetes education with a follow-up phone call 4 weeks later. The intervention group also received counseling derived from self-efficacy theory. This intervention included feedback on each participant's CGMS graph and used role model CGMS graphs to clearly depict glucose reductions in response to PA. Outcomes were assessed at baseline and 8 weeks. Participants receiving the intervention had higher self-efficacy scores than the control group for sticking to activity/resisting relapse at 8 weeks (p<0.05), indicating more confidence in maintaining a PA program. Intervention group participants light/sedentary activity minutes decreased significantly (p<0.05), moderate activity minutes increased significantly (p<0.05), and, HbA1c and BMI decreased significantly (p<0.05). These data suggest that PA counseling interventions using CGMS feedback for individuals with type 2 diabetes may improve PA levels and reduce risk factors for diabetes-related complications.

 


Testing social-cognitive mediators for objective estimates of physical activity from the Healthy Eating and Active Living for Diabetes in Primary Care Networks (HEALD-PCN) study.

Steven Johnson, David Lubans, Ana Mladenovic, Ronald Plotnikoff, Nandini Karunamuni, Jeffrey Johnson

Psychology, health & medicine [21:945-53] (2016)

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More evidence from prospective studies is needed to determine 'if' and 'how' social cognitive constructs mediate behaviour change. In a longitudinal study, we aimed to examine potential social cognitive mediators of objectively measured physical activity (PA) behaviour among people with type 2 diabetes (T2D) who participated in a six-month PA intervention. All participants from the proven effective Healthy Eating and Active Living for Diabetes in Primary Care Networks trial were included for this secondary analysis. Change in pedometer-derived daily step counts (baseline to six months) was the outcome of interest. Primary constructs of interest were from Social Cognitive Theory, however constructs from and Theory of Planned Behaviour were also tested in a mediating variable framework using a product-of-coefficients test. The sample (N = 198) had a mean age of 59.5 (SD 8.3) years, haemoglobin A1c 6.8% (SD 1.1), 50% women, BMI 33.6 kg/m(2) (SD 6.5), systolic pressure 125.6 mmHg (SD 16.2) and average daily steps were 5879 (SD 3130). Daily pedometer-determined steps increased for the intervention group compared to usual care control at six-months (1481 [SD 2631] vs. 336 [SD 2712]; adjusted p = .002). There was a significant action theory test effect for 'planning' (A = .21, SE = .10, p = .037), and significant conceptual theory test results for 'subjective norms' (B = 657, SE = 312, p = .037) and 'cons' (B = -664, SE = 270, p = .015). None of the constructs satisfied the criteria for mediation. We were unable to account for the effect of a pedometer-based PA intervention for people with T2D through our examination of mediators. Our findings are inconsistent with some literature concerning PA interventions in diabetes; this may be due to variability in measures used or in study populations.

 


Development and evaluation of a structured programme for promoting physical activity among seniors with intellectual disabilities: a study protocol for a cluster randomized trial.

Marieke van Schijndel-Speet, Heleen Evenhuis, Pepijn van Empelen, Ruud van Wijck, Michael Echteld

BMC public health [13:746] (2013)

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Older people with intellectual disabilities have very low physical activity levels. Well designed, theory-driven and evidence-based health promotion programmes for the target population are lacking. This paper describes the design of a cluster-randomised trial for a systematically developed health promotion programme aimed at improving physical activity and increasing fitness among seniors with intellectual disabilities. The Intervention Mapping protocol was used for programme development. After defining the programme's objectives, the following behavioural techniques were selected to achieve them: Tailoring, Education, Modelling, Mirroring, Feedback, Reinforcement and Grading. With professionals and managers of provider services for people with intellectual disabilities, we translated these strategies into a structured day-activity programme, that consisted of a physical activity and an education programme. The programme will be executed in five day-activity centres in groups of eight to ten seniors during eight months, whereas seniors in five other centres receive care as usual. The physical activity level, as measured in number of steps a day, will be used as primary outcome measurement. Secondary outcome measurements include motor fitness, cardio respiratory fitness, morphological and metabolic fitness, ADL, functional deterioration and depressive symptoms. Differences in the primary and secondary outcome measures between participants and controls will be analysed using generalized estimation equations, correcting for day-activity center as cluster. This paper provides insight into the development and content of a theory-driven intervention aimed at behavioural change in a population with a low intellectual level. Its evaluation design is described. The programme's applicability to other populations is discussed.

 


Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care.

Leah Avery, Falko Sniehotta, Sarah Denton, Nick Steen, Elaine McColl, Roy Taylor, Michael Trenell

Trials [15:46] (2014)

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Physical activity (PA) and nutrition are the cornerstones of diabetes management. Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes. However, it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care. This study will determine whether an evidence-informed multifaceted behaviour change intervention (Movement as Medicine for Type 2 Diabetes) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting. An open pilot study conducted in two primary care practices (phase one) will assess acceptability, feasibility and fidelity. Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures. A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability, feasibility, and fidelity of the intervention (versus usual clinical care) and trial processes over a 12-month period. Consultation behaviour involving fidelity of intervention delivery, diabetes and PA related knowledge, attitudes/beliefs, intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals. We will rehearse the collection of outcome data (with the focus on data yield and quality) for a future definitive trial, through outcome assessment at baseline, one, six and twelve months. An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and faithfully delivered in routine primary care. Movement as Medicine for Type 2 Diabetes will address an important gap in the evidence-base, that is, the need for interventions to increase free-living PA behaviour in adults with Type 2 diabetes. The multifaceted intervention incorporates an online accredited training programme for primary healthcare professionals and represents, to the best of our knowledge, the first of its kind in the United Kingdom. This study will establish whether the multifaceted behavioural intervention is acceptable and feasible in routine primary care. Movement as Medicine for Type 2 Diabetes (MaMT2D) was registered with Current Controlled Trials on the 14th January 2012: ISRCTN67997502. The first primary care practice was randomised on the 5th October 2012.

 


Evidence, theory and context: using intervention mapping to develop a worksite physical activity intervention.

Rosemary McEachan, Rebecca Lawton, Cath Jackson, Mark Conner, Jennifer Lunt

BMC public health [8:326] (2008)

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The workplace is an ideal setting for health promotion. Helping employees to be more physically active can not only improve their physical and mental health, but can also have economic benefits such as reduced sickness absence. The current paper describes the development of a three month theory-based intervention that aims to increase levels of moderate intensity physical activity amongst employees in sedentary occupations. The intervention was developed using an intervention mapping protocol. The intervention was also informed by previous literature, qualitative focus groups, an expert steering group, and feedback from key contacts within a range of organisations. The intervention was designed to target awareness (e.g. provision of information), motivation (e.g. goal setting, social support) and environment (e.g. management support) and to address behavioural (e.g. increasing moderate physical activity in work) and interpersonal outcomes (e.g. encourage colleagues to be more physically active). The intervention can be implemented by local facilitators without the requirement for a large investment of resources. A facilitator manual was developed which listed step by step instructions on how to implement each component along with a suggested timetable. Although time consuming, intervention mapping was found to be a useful tool for developing a theory based intervention. The length of this process has implications for the way in which funding bodies allow for the development of interventions as part of their funding policy. The intervention will be evaluated in a cluster randomised trial involving 1350 employees from 5 different organisations, results available September 2009.

 


Impact of school-based vegetable garden and physical activity coordinated health interventions on weight status and weight-related behaviors of ethnically diverse, low-income students: Study design and baseline data of the Texas, Grow! Eat! Go! (TGEG) cluster-randomized controlled trial.

A Evans, N Ranjit, D Hoelscher, C Jovanovic, M Lopez, A McIntosh, M Ory, L Whittlesey, L McKyer, A Kirk, C Smith, C Walton, N Heredia, J Warren

BMC public health [16:973] (2016)

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Coordinated, multi-component school-based interventions can improve health behaviors in children, as well as parents, and impact the weight status of students. By leveraging a unique collaboration between Texas AgriLife Extension (a federal, state and county funded educational outreach organization) and the University of Texas School of Public Health, the Texas Grow! Eat! Go! Study (TGEG) modeled the effectiveness of utilizing existing programs and volunteer infrastructure to disseminate an enhanced Coordinated School Health program. The five-year TGEG study was developed to assess the independent and combined impact of gardening, nutrition and physical activity intervention(s) on the prevalence of healthy eating, physical activity and weight status among low-income elementary students. The purpose of this paper is to report on study design, baseline characteristics, intervention approaches, data collection and baseline data. The study design for the TGEG study consisted of a factorial group randomized controlled trial (RCT) in which 28 schools were randomly assigned to one of 4 treatment groups: (1) Coordinated Approach to Child Health (CATCH) only (Comparison), (2) CATCH plus school garden intervention [Learn, Grow, Eat & Go! (LGEG)], (3) CATCH plus physical activity intervention [Walk Across Texas (WAT)], and (4) CATCH plus LGEG plus WAT (Combined). The outcome variables include student's weight status, vegetable and sugar sweetened beverage consumption, physical activity, and sedentary behavior. Parents were assessed for home environmental variables including availability of certain foods, social support of student health behaviors, parent engagement and behavior modeling. Descriptive data are presented for students (n = 1369) and parents (n = 1206) at baseline. The sample consisted primarily of Hispanic and African American (53 % and 18 %, respectively) and low-income (i.e., 78 % eligible for Free and Reduced Price School Meals program and 43 % food insecure) students. On average, students did not meet national guidelines for vegetable consumption or physical activity. At baseline, no statistical differences for demographic or key outcome variables among the 4 treatment groups were observed. The TGEG study targets a population of students and parents at high risk of obesity and related chronic conditions, utilizing a novel and collaborative approach to program formulation and delivery, and a rigorous, randomized study design.

 




Effectiveness of physical activity interventions in achieving behaviour change maintenance in young and middle aged adults: A systematic review and meta-analysis.

Jennifer Murray, Sarah Brennan, David French, Christopher Patterson, Frank Kee, Ruth Hunter

Social science & medicine (1982) [192:125-133] (2017)

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Physical activity (PA) interventions are generally effective in supporting short-term behaviour change, but increases are not always maintained. This review examined the effectiveness of PA interventions for behaviour change maintenance in young and middle-aged adults, and investigated which Behaviour Change Techniques (BCTs) and other intervention features were associated with maintenance. Six databases (Medline, EMBASE, PsycINFO, Cochrane Database of Systematic Reviews, CINAHL, Web of Science) were systematically searched. Eligibility criteria were controlled trials investigating the effectiveness of PA interventions with adult (mean age 18-64 years) non-clinical populations using validated measures of PA behaviour at baseline and ≥six months' post-baseline. Results were pooled in meta-analyses using standardised mean differences (SMD) at five time intervals (6-9, 9-15, 15-21, 21-24, >24 months). Moderator analyses investigated the influence of sample and intervention characteristics on PA maintenance at 6-9 months. Sixty-two studies were included. PA interventions had a significant effect on behaviour maintenance 6-15 months post-baseline relative to controls. Interventions had a larger effect on maintenance at 6-9 months (SMD = 0.28; 95% CI: 0.20, 0.35; I2 = 73%) compared to 9-15 months (SMD = 0.20; 95% CI: 0.13, 0.26; I2 = 70%). Beyond 15 months, PA measurements were infrequent with little evidence supporting maintenance. Moderator analyses showed some BCTs and intervention settings moderated PA outcomes at 6-9 months. A multivariable meta-regression model showed interventions using the BCTs 'Prompt self-monitoring of behavioural outcome' (b = 1.46, p < 0.01) and 'Use of follow-up prompts' (b = 0.38, p < 0.01) demonstrated greater effectiveness at promoting PA maintenance at 6-9 months. Interventions implemented in primary care (versus community or workplace/university) settings (b = -0.13, p = 0.10) tended to demonstrate less effectiveness. This review provides evidence of some effective BCTs for maintaining behaviour to 15 months. Greater consideration must be given to how future interventions encourage and measure maintenance of changes, and investigate broader psychological, social and environmental influences of PA behaviour. PROSPERO 2015:CRD42015025462.

 


Can implementation intentions and text messages promote brisk walking? A randomized trial.

Andrew Prestwich, Marco Perugini, Robert Hurling

Health psychology : official journal of the Division of Health Psychology, American Psychological Association [29:40-9] (2010)

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To test the efficacy in promoting brisk walking of two theory-based interventions that incorporate implementation intentions and text message (Short Message Service; SMS) reminders directed at one's walking-related plans or goals. Participants (N = 149) were randomized to one of three conditions (implementation intention + SMS plan reminder, implementation intention + SMS goal reminder, control) before completing measures at baseline and follow-up 4 weeks later. At follow-up, the experimental groups were given a surprise recall task concerning their plans. All participants completed an equivalent goal recall task. Validated self-report measures of physical activity and measures of implementation intention and goal recall, weight, and waist-to-hip ratio. Both intervention groups increased their brisk walking relative to the control group, without reducing other physical activity. The goal reminder group lost the most weight. The SMS plan reminder group recalled more of their plans than the SMS goal reminder group, but the latter were more successful in goal recall. Both interventions can promote brisk walking in sedentary populations. Text messages aid the recall of, and could enhance interventions that target, implementation intentions and goals.

 


Development of a behaviour change intervention to increase upper limb exercise in stroke rehabilitation.

Louise Connell, Naoimh McMahon, Judith Redfern, Caroline Watkins, Janice Eng

Implementation science : IS [10:34] (2015)

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Two thirds of survivors will achieve independent ambulation after a stroke, but less than half will recover upper limb function. There is strong evidence to support intensive repetitive task-oriented training for recovery after stroke. The number of repetitions needed is suggested to be in the order of hundreds, but this is not currently being achieved in clinical practice. In an effort to bridge this evidence-practice gap, we have developed a behaviour change intervention that aims to increase provision of upper limb repetitive task-oriented training in stroke rehabilitation. This paper aims to describe the systematic processes that took place in collaboratively developing the behaviour change intervention. The methods used in this study were not defined a priori but were guided by the Behaviour Change Wheel. The process was collaborative and iterative with four stages of development emerging (i) establishing an intervention development group; (ii) structured discussions to understand the problem, prioritise target behaviours and analyse target behaviours; (iii) collaborative design of theoretically underpinned intervention components and (iv) piloting and refining of intervention components. The intervention development group consisted of the research team and stroke therapy team at a local stroke rehabilitation unit. The group prioritised four target behaviours at the therapist level: (i) identifying suitable patients for exercises, (ii) provision of exercises, (iii) communicating exercises to family/visitors and (iv) monitoring and reviewing exercises. It also provides a method for self-monitoring performance in order to measure fidelity. The developed intervention, PRACTISE (Promoting Recovery of the Arm: Clinical Tools for Intensive Stroke Exercise), consists of team meetings and the PRACTISE Toolkit (screening tool and upper limb exercise plan, PRACTISE exercise pack and an audit tool). This paper provides an example of how the Behaviour Change Wheel may be applied in the collaborative development of a behaviour change intervention for health professionals. The process involved was resource-intensive, and the iterative process was difficult to capture. The use of a published behaviour change framework and taxonomy will assist replication in future research and clinical use. The feasibility and acceptability of PRACTISE is currently being explored in two other stroke rehabilitation units.

 


Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol for the PATHS randomised controlled trial.

Dominika Kwasnicka, Corneel Vandelanotte, Amanda Rebar, Benjamin Gardner, Camille Short, Mitch Duncan, Dawn Crook, Martin Hagger

BMC public health [17:518] (2017)

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Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals' physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ according to their focus on motivational, self-regulatory and/or habitual processes. Healthcare professionals (N = 192) will be recruited from four hospitals in Perth, Western Australia, via email lists, leaflets, and posters to participate in the four group randomised controlled trial. Participants will be randomised to one of four conditions: (1) education only (non-tailored information only), (2) education plus intervention components to enhance motivation, (3) education plus components to enhance motivation and self-regulation, and (4) education plus components to enhance motivation, self-regulation and habit formation. All intervention groups will receive a computer-tailored intervention administered via a web-based platform and will receive supporting text-messages containing tailored information, prompts and feedback relevant to each condition. All outcomes will be assessed at baseline, and at 3-month follow-up. The primary outcome assessed in this study is physical activity measured using activity monitors. Secondary outcomes include: quality of life, stress, anxiety, sleep, and absenteeism. Website engagement, retention, preferences and intervention fidelity will also be evaluated as well as potential mediators and moderators of intervention effect. This is the first study to examine a tailored, technology-supported intervention aiming to increase physical activity in healthcare professionals. The study will evaluate whether including additional theory-based behaviour change techniques aimed at promoting motivation, self-regulation and habit will lead to increased physical activity participation relative to information alone. The online platform developed in this study has potential to deliver efficient, scalable and personally-relevant intervention that can be translated to other occupational settings. Australian New-Zealand Clinical Trial Registry: ACTRN12616000462482, submitted 29/03/2016, prospectively registered 8/04/2016.

 


Behaviour change intervention increases physical activity, spinal mobility and quality of life in adults with ankylosing spondylitis: a randomised trial.

Tom O'Dwyer, Ann Monaghan, Jonathan Moran, Finbar O'Shea, Fiona Wilson

Journal of physiotherapy (2016)

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Does a 3-month behaviour change intervention targeting physical activity (PA) increase habitual physical activity in adults with ankylosing spondylitis (AS)? Does the intervention improve health-related physical fitness, AS-related features, and attitude to exercise? Are any gains maintained over a 3-month follow-up? Parallel-group, randomised, controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. Forty adults with a diagnosis of AS, on stable medication, and without PA-limiting comorbidities. Over a 3-month period, the experimental group engaged in individually-tailored, semi-structured consultations aiming to motivate and support individuals in participating in PA. The control group continued with usual care. The primary outcome was PA measured by accelerometry over 1 week. Secondary outcomes included clinical questionnaires and measures of health-related physical fitness. Measures were taken at baseline, post-intervention, and after a 3-month follow-up period. Baseline characteristics were similar across groups, except age and body composition. There were statistically significant, moderate-to-large time-by-group effects in health-enhancing PA (mixed-design ANOVA for overall effect F(2, 76)=14.826, p<0.001), spinal mobility (F(2, 76)=5.691, p<0.005) and quality of life (χ(2)(2)=8.400, p<0.015) favouring the intervention group; post-intervention improvements were sustained 3 months later. No significant effects were seen in other physical fitness outcomes or on clinical questionnaires. No adverse effects were reported during the study. Health-enhancing PA, spinal mobility and quality of life were significantly improved after the intervention, and improvements were maintained at 3-month follow-up. NCT02374502. [O'Dwyer T, Monaghan A, Moran J, O'Shea F, Wilson F (2016) Behaviour change intervention increases physical activity, spinal mobility and quality of life in adults with ankylosing spondylitis: a randomised trial.Journal of PhysiotherapyXX: XX-XX].

 


How to reduce sitting time? A review of behaviour change strategies used in sedentary behaviour reduction interventions among adults.

Benjamin Gardner, Lee Smith, Fabiana Lorencatto, Mark Hamer, Stuart Biddle

Health psychology review [10:89-112] (2016)

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Sedentary behaviour - i.e., low energy-expending waking behaviour while seated or lying down - is a health risk factor, even when controlling for physical activity. This review sought to describe the behaviour change strategies used within interventions that have sought to reduce sedentary behaviour in adults. Studies were identified through existing literature reviews, a systematic database search, and hand-searches of eligible papers. Interventions were categorised as 'very promising', 'quite promising', or 'non-promising' according to observed behaviour changes. Intervention functions and behaviour change techniques were compared across promising and non-promising interventions. Twenty-six eligible studies reported thirty-eight interventions, of which twenty (53%) were worksite-based. Fifteen interventions (39%) were very promising, eight quite promising (21%), and fifteen non-promising (39%). Very or quite promising interventions tended to have targeted sedentary behaviour instead of physical activity. Interventions based on environmental restructuring, persuasion, or education were most promising. Self-monitoring, problem solving, and restructuring the social or physical environment were particularly promising behaviour change techniques. Future sedentary reduction interventions might most fruitfully incorporate environmental modification and self-regulatory skills training. The evidence base is, however, weakened by low-quality evaluation methods; more RCTs, employing no-treatment control groups, and collecting objective data are needed.

 


Social cognitive theory mediators of physical activity in a lifestyle program for cancer survivors and carers: findings from the ENRICH randomized controlled trial.

F Stacey, E James, K Chapman, D Lubans

The international journal of behavioral nutrition and physical activity [13:49] (2016)

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Despite increasing numbers of cancer survivors and evidence that diet and physical activity improves the health of cancer survivors, most do not meet guidelines. Some social cognitive theory (SCT)-based interventions have increased physical activity behavior, however few have used objective physical activity measures. The Exercise and Nutrition Routine Improving Cancer Health (ENRICH) randomized controlled trial reported a significant intervention effect for the primary outcome of pedometer-assessed step counts at post-test (8-weeks) and follow-up (20-weeks). The aim of this study was to test whether the SCT constructs operationalized in the ENRICH intervention were mediators of physical activity behavior change. Randomized controlled trial with 174 cancer survivors and carers assessed at baseline, post-test (8-weeks), and follow-up (20-weeks). Participants were randomized to the ENRICH six session face-to-face healthy lifestyle program, or to a wait-list control. Hypothesized SCT mediators of physical activity behavior change (self-efficacy, behavioral goal, outcome expectations, impediments, and social expectations) were assessed using valid and reliable scales. Mediation was assessed using the Preacher and Hayes SPSS INDIRECT macro. At eight weeks, there was a significant intervention effect on behavioral goal (A = 9.12, p = 0.031) and outcome expectations (A = 0.25, p = 0.042). At 20 weeks, the intervention had a significant effect on self-efficacy (A = 0.31, p = 0.049) and behavioral goal (A = 13.15, p = 0.011). Only changes in social support were significantly associated with changes in step counts at eight weeks (B = 633.81, p = 0.023). Behavioral goal was the only SCT construct that had a significant mediating effect on step counts, and explained 22 % of the intervention effect at 20 weeks (AB = 397.9, 95 % CI 81.5-1025.5). SCT constructs had limited impact on objectively-assessed step counts in a multiple health behavior change intervention for cancer survivors and their carers. Behavioral goal measured post-intervention was a significant mediator of pedometer-assessed step counts at 3-months after intervention completion, and explained 22 % of the intervention effect. Future research should examine the separate impact of goals and planning, as well as examining mediators of behavior maintenance in physical activity interventions targeting cancer survivors. Australian and New Zealand Clinical Trials registry ANZCTRN1260901086257 .

 


Development and exploratory cluster-randomised opportunistic trial of a theory-based intervention to enhance physical activity among adolescents.

Vera Araújo-Soares, Teresa McIntyre, Graeme MacLennan, Falko Sniehotta

Psychology & health [24:805-22] (2009)

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This article reports the development and exploratory testing of a school-based intervention programme designed to enhance levels of physical activity in adolescents. The intervention is based on social cognitive theory (SCT), self-regulation theory (SRT) and planning as evidence-based mediators of physical activity changes. Two classes, paired on socio-economic variables, were selected from each of eight Portuguese schools and randomly assigned to an intervention or control group (N = 291). Primary outcome was 'moderate to vigorous physical activity' (International Physical Activity Questionnaire) measured pre and post intervention and at three and nine months follow-up. SCT, SRT and planning variables were secondary outcomes measured pre and post intervention. At post test, participants in the intervention group reported 18 min per week more physical activity (PA), adjusted for pre-intervention, age and sex, than those in the control group (95% confidence interval -10 to 46; p = 0.249). This difference increased to 33 min (95% CI-4 to 71; p = 0.082) at three months and to 57 min (95% CI 13 to 101, p = 0.008) at nine month follow-up. Moreover, the intervention resulted in changes of some of the theoretical target variables, including outcome expectancies and coping planning. However, no evidence was found for the changes in theoretical moderators to mediate the intervention effects on behaviour. Implications for theory and for future research are discussed.

 


Heart-to-Heart: promoting walking in rural women through motivational interviewing and group support.

Cindy Perry, Anne Rosenfeld, Jill Bennett, Kathleen Potempa

The Journal of cardiovascular nursing [22:304-12] ()

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Walking can significantly increase cardiorespiratory fitness and thereby reduce the incidence of heart disease in women. However, there is a paucity of research aimed at increasing walking in rural women, a high-risk group for heart disease and one for which exercise strategies may pose particular challenges. This study tested Heart-to-Heart (HTH), a 12-week walking program, designed to increase fitness through walking in rural women. Heart-to-Heart integrated individual-oriented strategies, including motivational interviewing, and group-based strategies, including team building. Forty-six rural women were randomized to either HTH or a comparison group. The primary outcome of cardiorespiratory fitness and secondary outcomes of self-efficacy and social support were measured preintervention and post-intervention. Group differences were analyzed with repeated-measures analysis of variance. Women in HTH group had a greater improvement in cardiorespiratory fitness (P =.057) and in social support (P =.004) compared with women in the comparison group. Neither group of women experienced a change in exercise self-efficacy (P =.814). HTH was effective in improving cardiorespiratory fitness in a sample of rural women. Further research is needed to refine HTH and determine the optimal approach in rural women to increase their wa