? All interventions
| Katherine White, Deborah Terry, Carolyn Troup, Lynn Rempel, Paul Norman, Kerry Mummery, Malcolm Riley, Natasha Posner, Justin Kenardy|
Journal of aging and physical activity [20:281-99] (2012)
A randomized controlled trial evaluated the effectiveness of a 4-wk extended theory of planned behavior (TPB) intervention to promote regular physical activity and healthy eating among older adults diagnosed with Type 2 diabetes or cardiovascular disease (N = 183). Participants completed TPB measures of attitude, subjective norm, perceived behavioral control, and intention, as well as planning and behavior, at preintervention and 1 wk and 6 wk postintervention for each behavior. No significant time-by-condition effects emerged for healthy eating. For physical activity, significant time-by-condition effects were found for behavior, intention, planning, perceived behavioral control, and subjective norm. In particular, compared with control participants, the intervention group showed short-term improvements in physical activity and planning, with further analyses indicating that the effect of the intervention on behavior was mediated by planning. The results indicate that TPB-based interventions including planning strategies may encourage physical activity among older people with diabetes and cardiovascular disease.
| Leah Avery, Falko Sniehotta, Sarah Denton, Nick Steen, Elaine McColl, Roy Taylor, Michael Trenell|
Trials [15:46] (2014)
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.
| Chandra Osborn, K Amico, Noemi Cruz, Ann O'Connell, Rafael Perez-Escamilla, Seth Kalichman, Scott Wolf, Jeffrey Fisher|
Health education & behavior : the official publication of the Society for Public Health Education [37:849-62] (2010)
The information-motivation-behavioral skills (IMB) model of health behavior change informed the design of a brief, culturally tailored diabetes self-care intervention for Puerto Ricans with type 2 diabetes. Participants (n = 118) were recruited from an outpatient, primary care clinic at an urban hospital in the northeast United States. ANCOVA models evaluated intervention effects on food label reading, diet adherence, physical activity, and glycemic control (HbA1c). At follow-up, the intervention group was reading food labels and adhering to diet recommendations significantly more than the control group. Although the mean HbA1c values decreased in both groups (
0.27% absolute decrease), only the intervention group showed a significant improvement from baseline to follow-up (p < .008), corroborating improvements in diabetes self-care behaviors. Findings support the use of the IMB model to culturally tailor diabetes interventions and to enhance patients' knowledge, motivation, and behavior skills needed for self-care.
| Kevin Cradock, Gearóid ÓLaighin, Francis Finucane, Rhyann McKay, Leo Quinlan, Kathleen A Martin Ginis, Heather Gainforth|
Diabetes care [40:1800-1810] (2017)
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.
| V Franklin, A Waller, C Pagliari, S Greene|
Diabetic medicine : a journal of the British Diabetic Association [23:1332-8] (2006)
To assess Sweet Talk, a text-messaging support system designed to enhance self-efficacy, facilitate uptake of intensive insulin therapy and improve glycaemic control in paediatric patients with Type 1 diabetes.
One hundred and twenty-six patients fulfilled the eligibility criteria; Type 1 diabetes for > 1 year, on conventional insulin therapy, aged 8-18 years. Ninety-two patients were randomized to conventional insulin therapy (n = 28), conventional therapy and Sweet Talk (n = 33) or intensive insulin therapy and Sweet Talk (n = 31). Goal-setting at clinic visits was reinforced by daily text-messages from the Sweet Talk software system, containing personalized goal-specific prompts and messages tailored to patients' age, sex and insulin regimen.
HbA(1c) did not change in patients on conventional therapy without or with Sweet Talk (10.3 +/- 1.7 vs. 10.1 +/- 1.7%), but improved in patients randomized to intensive therapy and Sweet Talk (9.2 +/- 2.2%, 95% CI -1.9, -0.5, P < 0.001). Sweet Talk was associated with improvement in diabetes self-efficacy (conventional therapy 56.0 +/- 13.7, conventional therapy plus Sweet Talk 62.1 +/- 6.6, 95% CI +2.6, +7.5, P = 0.003) and self-reported adherence (conventional therapy 70.4 +/- 20.0, conventional therapy plus Sweet Talk 77.2 +/- 16.1, 95% CI +0.4, +17.4, P = 0.042). When surveyed, 82% of patients felt that Sweet Talk had improved their diabetes self-management and 90% wanted to continue receiving messages.
Sweet Talk was associated with improved self-efficacy and adherence; engaging a classically difficult to reach group of young people. While Sweet Talk alone did not improve glycaemic control, it may have had a role in supporting the introduction of intensive insulin therapy. Scheduled, tailored text messaging offers an innovative means of supporting adolescents with diabetes and could be adapted for other health-care settings and chronic diseases.
| Katie Morton, Stephen Sutton, Wendy Hardeman, Jacqui Troughton, Tom Yates, Simon Griffin, Melanie Davies, Kamlesh Khunti, Helen Eborall|
JMIR mHealth and uHealth [3:e105] (2015)
Mobile technologies for health (mHealth) represent a promising strategy for reducing type 2 diabetes (T2DM) risk. The PROPELS trial investigates whether structured group-based education alone or supplemented with a follow-on support program combining self-monitoring with pedometers and tailored text-messaging is effective in promoting and maintaining physical activity among people at high risk of T2DM.
This paper describes the iterative development of the PROPELS follow-on support program and presents evidence on its acceptability and feasibility.
We used a modified mHealth development framework with four phases: (1) conceptualization of the follow-on support program using theory and evidence, (2) formative research including focus groups (n=15, ages 39-79 years), (3) pre-testing focus groups using a think aloud protocol (n=20, ages 52-78 years), and (4) piloting (n=11). Analysis was informed by the constant comparative approach, with findings from each phase informing subsequent phases.
The first three phases informed the structure, nature, and content of the follow-on support program, including the frequency of text messages, the need for tailored content and two-way interaction, the importance of motivational messages based on encouragement and reinforcement of affective benefits (eg, enjoyment) with minimal messages about weight and T2DM risk, and the need for appropriate language. The refined program is personalized and tailored to the individual's perceived confidence, previous activity levels, and physical activity goals. The pilot phase indicated that the program appeared to fit well with everyday routines and was easy to use by older adults.
We developed a feasible and innovative text messaging and pedometer program based on evidence and behavior change theory and grounded in the experiences, views, and needs of people at high diabetes risk. A large scale trial is testing the effectiveness of this 4-year program over and above structured group education alone.
International Standard Randomized Controlled Trial Number (ISRCTN): 83465245; http://www.controlled-trials.com/ISRCTN83465245/83465245 (Archived by WebCite at http://www.webcitation.org/6dfSmrVAe).
| Russell Glasgow, Shawn Boles, H Garth McKay, Edward Feil, Manuel Barrera|
Preventive medicine [36:410-9] (2003)
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.
| JM Gleeson-Kreig|
The Diabetes educator [32:69-77] ()
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.
| Michel Moreau, Marie-Pierre Gagnon, François Boudreau|
JMIR research protocols [4:e25] (2015)
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.
| SC Wangberg|
Health education research [23:170-9] (2008)
The main objective of this study was to assess whether self-efficacy (SE) could function as a moderator of the effect of a tailored Internet-based intervention aimed at increasing self-reported diabetes self-care behaviours. In a two-group, 1-month interval pre-test-post-test randomized controlled trial, participants (N = 64) were assigned at random to either a group that received an intervention on the area of self-care (blood glucose monitoring, diet management or physical activity) for which the reported SE was lowest (LSE group) or to a group that received an intervention on area of self-care for which the reported SE was highest (HSE group). Improvements in self-care were observed for both groups, but the HSE group improved more. Self-care also increased for those areas that the intervention did not target. Furthermore, SE levels decreased from baseline to follow-up. This study suggests that SE can function as a moderator in a behavioural intervention for diabetes self-care, and hence that initial level of SE provides relevant information for tailoring such interventions.
| Steven Johnson, David Lubans, Ana Mladenovic, Ronald Plotnikoff, Nandini Karunamuni, Jeffrey Johnson|
Psychology, health & medicine [21:945-53] (2016)
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.
| 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)
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.
| Nancy Allen, James Fain, Barry Braun, Stuart Chipkin|
Diabetes research and clinical practice [80:371-9] (2008)
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.
| Elroy Aguiar, Philip Morgan, Clare Collins, Ronald Plotnikoff, Myles Young, Robin Callister|
Contemporary clinical trials [39:132-44] (2014)
Intensive lifestyle interventions have been successful in reducing type 2 diabetes incidence. Whether intensive programmes requiring face-to-face contact, trained staff and access to facilities are feasible, on a larger scale, has been debated.
The aim of this study is to determine the feasibility and efficacy of a lifestyle intervention for type 2 diabetes prevention in men using an assessor-blinded, parallel-group, randomised controlled trial. The 'Type 2 Diabetes PULSE (Prevention Using LifeStyle Education) Programme for Men' is a 6-month, self-administered, gender-tailored lifestyle intervention, with a multicomponent approach (weight loss, dietary modification, aerobic exercise and resistance training). Eligible men were aged 18-65 years, overweight/obese (BMI 25-40 kg·m(-2)) and at high-risk for type 2 diabetes (score ≥ 12, Australian diabetes risk tool). Men with diagnosed prediabetes were eligible, but those with type 1 and 2 diabetes were ineligible. Randomisation was stratified by age (
| Louise Maranda, May Lau, Sunita Stewart, Olga Gupta|
The Diabetes educator [41:224-30] (2015)
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.
| 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)
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.
| Justin Presseau, Noah Ivers, James Newham, Keegan Knittle, Kristin Danko, Jeremy Grimshaw|
Implementation science : IS [10:55] (2015)
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.
| Mihiretu Kebede, Tatjana Liedtke, Tobias Möllers, Claudia Pischke|
Journal of medical Internet research [19:e348] (2017)
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.
| Bart Johan Thoolen, Denise de Ridder, Jozien Bensing, Kees Gorter, Guy Rutten|
Psychology & health [24:237-54] (2009)
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.
| Elizabeth Eakin, Marina Reeves, Sheleigh Lawler, Brian Oldenburg, Chris Del Mar, Ken Wilkie, Adele Spencer, Diana Battistutta, Nicholas Graves|
Contemporary clinical trials [29:439-54] (2008)
Physical activity and dietary behavior changes are important to both the primary prevention and secondary management of the majority of our most prevalent chronic conditions (i.e., cardiovascular disease, hypertension, type 2 diabetes, breast and colon cancer). With over 85% of Australian adults visiting a general practitioner each year, the general practice setting has enormous potential to facilitate wide scale delivery of health behaviour interventions. However, there are also many barriers to delivery in such settings, including lack of time, training, resources and remuneration. Thus there is an important need to evaluate other feasible and effective means of delivering evidence-based physical activity and dietary behaviour programs to patients in primary care, including telephone counseling interventions.
Using a cluster randomized design with practice as the unit of randomization, this study evaluated a telephone-delivered intervention for physical activity and dietary change targeting patients with chronic conditions (type 2 diabetes or hypertension) recruited from primary care practices in a socially disadvantaged community in Queensland, Australia. Ten practices were randomly assigned to the telephone intervention or to usual care, and 434 patients were recruited. Patients in intervention practices received a workbook and 18 calls over 12 months. Assessment at baseline, 4-, 12- and 18-months allows for assessment of initial change and maintenance of primary outcomes (physical activity and dietary behavior change) and secondary outcomes (quality of life, cost-effectiveness, support for health behavior change).
This effectiveness trial adds to the currently limited number of telephone-delivered intervention studies targeting both physical activity and dietary change. It also addresses some of the shortcomings of previous trials by targeting patients from a disadvantaged community, and by including detailed reporting on participant representativeness, intervention implementation and cost-effectiveness, as well as an evaluation of maintenance of health behavior change.
| Michael van Vugt, Maartje de Wit, Steven Hendriks, Yvonne Roelofsen, Henk Bilo, Frank Snoek|
BMC endocrine disorders [13:53] (2013)
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.
| 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)
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.
| David Lubans, Ronald Plotnikoff, Mary Jung, Neil Eves, Ron Sigal|
Psychology & health [27:1388-404] (2012)
A poor understanding of behaviour change mechanisms has hindered the development of effective physical activity interventions. The aim of this study was to identify potential mediators of change in a home-based resistance training (RT) program for obese individuals with type 2 diabetes. Obese individuals with type 2 diabetes (N = 48) were randomly allocated to either an RT intervention (n = 27) or a control group (n = 21) for the 16-week study period. The study sample included 16 men and 32 women and the mean age of participants was 54.4 (±11.7) years. Participants in the RT group received a multi-gym and dumbbells and home supervision from a certified personal trainer. RT behaviour was measured using a modified Godin Leisure Time Questionnaire. Social-cognitive constructs were measured and tested in a mediating variable framework using a product-of-coefficients test. The intervention had a significant effect on RT behaviour (p < 0.001) and muscular strength (p < 0.001). The intervention had a significant effect on RT planning strategies (p < 0.01), which mediated the effect of the intervention on RT behaviour. The home-based RT program successfully targeted participants' RT planning strategies which contributed to their exercise adherence.
| 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.
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.