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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.

 



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.

 



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.

 


Project PREVENT: a randomized trial to reduce multiple behavioral risk factors for colon cancer.

Karen Emmons, Colleen McBride, Elaine Puleo, Kathryn Pollak, Elizabeth Clipp, Karen Kuntz, Bess Marcus, Melissa Napolitano, Jane Onken, Frank Farraye, Robert Fletcher

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology [14:1453-9] (2005)

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This report examines the outcome data for Project PREVENT, a two-site randomized control trial designed to reduce behavioral risk factors for colorectal cancer among individuals who have been diagnosed with adenomatous colon polyps. The study sample included 1,247 patients with recent diagnosis of adenomatous colorectal polyps. Within 4 weeks following the polypectomy, participants completed a baseline survey by telephone, and were randomized to either Usual Care (UC) or the PREVENT intervention, which was designed to target multiple risk factors. The intervention consisted of a telephone-delivered intervention plus tailored materials, and focused on the six primary behavioral risk factors for colorectal cancer, including red meat consumption, fruit and vegetable intake, multivitamin intake, alcohol, smoking, and physical inactivity. Participation in the PREVENT intervention was associated with a significantly greater reduction in prevalence of multiple risk factors for colorectal cancer compared with UC. Only about one third of UC participants dropped any risk factors during the study period, compared with almost half of the PREVENT participants. PREVENT participants were also significantly more likely to change more than one behavior than UC participants. The PREVENT intervention was effective in helping patients change multiple risk factors. These results provide further support that more comprehensive interventions that move beyond emphasis on a single risk factor are acceptable to patient populations, can result in improvements, and are cost effective.

 


Structured goal planning and supportive telephone followup in rheumatology care: results from a pragmatic stepped-wedge cluster-randomized trial.

Gunnhild Berdal, Ingvild Bø, Turid Dager, Anne Dingsør, Siv Eppeland, Jon Hagfors, Bente Hamnes, Petter Mowinckel, Merete Nielsen, Anne-Lene Sand-Svartrud, Bente Slungaard, Sigrid Wigers, Kåre Hagen, Hanne Dagfinrud, Ingvild Kjeken

Arthritis care & research (2018)

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To evaluate patient-reported health effects of an add-on structured goal planning and supportive telephone followup rehabilitation program compared with traditional rehabilitation programs in patients with rheumatic diseases. In this pragmatic stepped-wedge cluster-randomized controlled trial 389 patients with rheumatic diseases recruited from six rehabilitation centres received either traditional rehabilitation or traditional rehabilitation extended with an add-on program tailored to individual needs. The add-on program comprised a self-management booklet and usage of motivational interviewing in structured individualized goal planning and four supportive followup phone-calls after discharge. Data were collected by questionnaires on admission and discharge from rehabilitation stay, and 6 months and 12 months after discharge. Primary outcome was health-related quality of life (HR-QoL) measured by the Patient Generated Index (PGI, 0-100, 0=low). Secondary outcomes included patient-reported health status, self-efficacy, pain, fatigue, global disease activity and motivation for change. The main statistical analysis was a linear repeated measures mixed model performed on the intention to treat population using all available data. A significant treatment effect of the add-on intervention on HR-QoL was found on discharge (mean difference = 3.32 [95% CI: 0.27, 6.37], p=0.03). No significant between-group differences were found after 6 or 12 months. Both groups showed positive changes in HR-QoL following rehabilitation which gradually declined, although the values remained at higher levels after 6 and 12 months compared with baseline values. The add-on program enhanced the short-term effect of rehabilitation with respect to patient-specific HR-QoL, but it did not prolong the effect as intended. This article is protected by copyright. All rights reserved.

 


PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes (PROPELS): study protocol for a randomized controlled trial.

Tom Yates, Simon Griffin, Danielle Bodicoat, Gwen Brierly, Helen Dallosso, Melanie Davies, Helen Eborall, Charlotte Edwardson, Mike Gillett, Laura Gray, Wendy Hardeman, Sian Hill, Katie Morton, Stephen Sutton, Jacqui Troughton, Kamlesh Khunti

Trials [16:289] (2015)

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The prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes. A multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40-74 years for White European, or 25-74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4% (42 and 47 mmol/mol) or with a previously recorded plasma glucose level or HbA1c value within the high risk (prediabetes) range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants. Participants are randomly assigned to either: 1) the control group who receive a detailed advice leaflet; 2) the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3) the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change. This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention. ISRCTN83465245 Trial registration date: 14/06/2012.

 


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.

 


The effects of smoking cessation counseling by midwives on Dutch pregnant women and their partners.

Hein De Vries, Martijntje Bakker, Patricia Dolan Mullen, Gerard van Breukelen

Patient education and counseling [63:177-87] (2006)

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Smoking during pregnancy is an important problem in the Netherlands. We tested the effectiveness of a health counseling method by midwives using a RCT. Four provinces with 42 practices including 118 midwives were randomly assigned to the experimental or control condition. Midwives in the experimental group provided brief health counseling, self-help materials on smoking cessation during pregnancy and early postpartum, and a partner booklet. Controls received routine care. The main outcome measures were 7-day abstinence, continuous abstinence, and partner smoking at 6 weeks post-intervention (T1) and 6 weeks postpartum (T2). Multi-level analysis revealed significant differences between both conditions at T1 and T2 using intention-to-treat analysis. Nineteen percent of the experimental group reported 7-day abstinence compared to 7% of the control group at T1, and 21 and 12%, respectively, at T2. For continuous abstinence these percentages were 12% in the experimental group and 3% in the control group. The partner intervention was not successful. The intervention resulted in significant effects on smoking behavior for pregnant women, but not for partner smoking. The program realized short-term effects. An important precondition is that midwives need a proper training.

 


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.

 



Negotiating Tensions Between Theory and Design in the Development of Mailings for People Recovering From Acute Coronary Syndrome.

Holly Witteman, Justin Presseau, Angl Emily Nicholas, Iffat Jokhio, J Schwalm, Jeremy Grimshaw, Beth Bosiak, Madhu Natarajan, Noah Ivers

JMIR human factors [4:e6] (2017)

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Taking all recommended secondary prevention cardiac medications and fully participating in a formal cardiac rehabilitation program significantly reduces mortality and morbidity in the year following a heart attack. However, many people who have had a heart attack stop taking some or all of their recommended medications prematurely and many do not complete a formal cardiac rehabilitation program. The objective of our study was to develop a user-centered, theory-based, scalable intervention of printed educational materials to encourage and support people who have had a heart attack to use recommended secondary prevention cardiac treatments. Prior to the design process, we conducted theory-based interviews and surveys with patients who had had a heart attack to identify key determinants of secondary prevention behaviors. Our interdisciplinary research team then partnered with a patient advisor and design firm to undertake an iterative, theory-informed, user-centered design process to operationalize techniques to address these determinants. User-centered design requires considering users' needs, goals, strengths, limitations, context, and intuitive processes; designing prototypes adapted to users accordingly; observing how potential users respond to the prototype; and using those data to refine the design. To accomplish these tasks, we conducted user research to develop personas (archetypes of potential users), developed a preliminary prototype using behavior change theory to map behavior change techniques to identified determinants of medication adherence, and conducted 2 design cycles, testing materials via think-aloud and semistructured interviews with a total of 11 users (10 patients who had experienced a heart attack and 1 caregiver). We recruited participants at a single cardiac clinic using purposive sampling informed by our personas. We recorded sessions with users and extracted key themes from transcripts. We held interdisciplinary team discussions to interpret findings in the context of relevant theory-based evidence and iteratively adapted the intervention accordingly. Through our iterative development and testing, we identified 3 key tensions: (1) evidence from theory-based studies versus users' feelings, (2) informative versus persuasive communication, and (3) logistical constraints for the intervention versus users' desires or preferences. We addressed these by (1) identifying root causes for users' feelings and addressing those to better incorporate theory- and evidence-based features, (2) accepting that our intervention was ethically justified in being persuasive, and (3) making changes to the intervention where possible, such as attempting to match imagery in the materials to patients' self-images. Theory-informed interventions must be operationalized in ways that fit with user needs. Tensions between users' desires or preferences and health care system goals and constraints must be identified and addressed to the greatest extent possible. A cluster randomized controlled trial of the final intervention is currently underway.

 


Effects of integrating pedometers, parental materials, and E-mail support within an extracurricular school sport intervention.

David Lubans, Philip Morgan, Robin Callister, Clare Collins

The Journal of adolescent health : official publication of the Society for Adolescent Medicine [44:176-83] (2009)

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The objective of this study was to evaluate the impact of a school-based intervention (Program X) incorporating pedometers and e-mail support on physical activity, sedentary behavior, and healthy eating in adolescents. A randomized control trial was used to evaluate the impact of the Program X intervention. Six schools (N = 124 participants; mean age 14.1 +/- .8 years) were randomized to intervention or control conditions for the 6-month study period. Objectively recorded physical activity (mean steps/day), self-reported sedentary behavior, and dietary habits were measured at baseline and at 6-month follow-up and intervention effects were assessed using repeated-measures analysis of variance and chi(2) tests. Participants in the intervention group increased their step counts by 956 +/- 4107 steps/day (boys) and 999 +/- 1999 (girls). Repeated-measures analysis of variance revealed significant group-by-time interactions for boys (F = 7.4, p = .01, d = .80) and girls (F = 29.6, p <.001, d = 1.27) for mean steps/day. The intervention significantly decreased the number of energy-dense/low-nutrient snacks consumed by boys (chi(2) = 4.0, p = .043) and increased the number of fruit serves among girls (chi(2) = 4.8, p = .028). The intervention did not have a statistically significant effect on sedentary behavior. A school-based intervention incorporating physical activity monitoring using pedometers and e-mail support was successful in promoting physical activity and selected healthy eating behaviors in adolescent boys and girls.

 


Effects of a self-determination theory-based mail-mediated intervention on adults' exercise behavior.

Susan Levy, Bradley Cardinal

American journal of health promotion : AJHP [18:345-9] ()

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To examine the effect of a mail-mediated intervention, based on self-determination theory, on adults'exercise behavior. The study was a randomized control trial conducted over a 2-month period. Of the initial 185 volunteer participants, 126 (68.1%) completed questionnaires at baseline, 1 month, and 2 months. Participants in intervention-only and intervention-plus-booster groups received a mail-delivered packet containing strategies designed to promote perceptions of autonomy, competence, and relatedness regarding exercise. Those in a control group received an American Heart Association physical-activity facts packet. After 1 month, those in the intervention-plus-booster group received a booster postcard, reiterating the main points of the initial intervention packet. Exercise behavior was the primary outcome variable. Perceptions of autonomy, competence, and relatedness were evaluated as mediating variables. Separate 3 (group) x 3 (time) repeated measures analyses of variance conducted for men and women revealed that for women, all three groups significantly increased exercise levels over the 2-month period. No significant interactions were found regarding the influence of the intervention on the mediating variables. A process evaluation indicated a lack of compliance regarding completing intervention-packet worksheets. Findings suggested that more intensive interventions and greater fidelity of treatment may be needed to evidence change in exercise behavior.