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Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program.

ABSTRACT: The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in overweight and obese individuals. However, one-on-one DPP sessions are costly. As a cost-saving alternative, a group version of the DPP, called Group Lifestyle Balance program (GLB), has been developed but has been shown to be less effective. The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques, namely if-then plans and their mental practice, into the program.A total of 154 participants will be randomized to a standard or enriched GLB program. For the enriched GLB program, if-then plans and their mental practice will be integrated into the standard GLB program. Participants will be overweight or obese men and women (BMI of 28 to 45 kg/m2, waist circumference???88 for women, ? 102 for men, 18 to 75 years of age) who do less than 200 minutes of self-reported moderate or vigorous exercise per week. Measures will be completed at baseline, 3 months, post-intervention (12 months), and 12 months post-intervention (24 months). The primary outcome measure is weight loss at 3, 12, and 24 months. Secondary outcomes include percent reaching weight loss goal, physical activity at 3, 12, and 24 months, and weight-related risk factors (waist circumference, hemoglobin A1c, systolic/diastolic blood pressure, total cholesterol/HDL ratio). Standardized training of the life-style coaches, use of standardized manuals, and audio taping and reviewing of the sessions will ensure intervention fidelity.The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems. Ethical clearance has been received from the Research Ethics and Compliance Board of the Faculty of Medicine Research and Graduate Studies Office at McGill University (Montreal, Canada).ClinicalTrials.gov Identifier: NCT02008435. Registered 6 December 2013.

SUBMITTER: Knauper B

PROVIDER: S-EPMC4032631 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program.

Knäuper Bärbel B Ivanova Elena E Xu Zhen Z Chamandy Melodie M Lowensteyn Ilka I Joseph Lawrence L Luszczynska Aleksandra A Grover Steven S

BMC public health 20140518

<h4>Background</h4>The Diabetes Prevention Program (DPP) is highly effective in promoting weight loss in overweight and obese individuals. However, one-on-one DPP sessions are costly. As a cost-saving alternative, a group version of the DPP, called Group Lifestyle Balance program (GLB), has been developed but has been shown to be less effective. The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques, name ...[more]

PMID: 24885388

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Project description:BACKGROUND:Current evidence suggests that some of the most effective weight loss approaches are changes in dietary and physical activity behaviors through lifestyle modification programs. The Group Lifestyle Balance (GLB) program is a group-based behavior modification program aimed at changing diet and physical activity for weight loss. It was developed to be more cost-effective and easier to disseminate than its individually administered parent program, the Diabetes Prevention Program (DPP). However, the average weight loss following participation in the GLB is only approximately 3.5%, with low long-term weight loss maintenance. PURPOSE:We aimed to optimize the weight loss outcomes of the GLB to increase the efficacy already afforded by its cost-effectiveness and ease of dissemination. We did this by integrating the habit formation tool of if-then plans into the program. This program is called the enriched GLB or the McGill Comprehensive Health Improvement (CHIP) Healthy Weight Program. Results at 3 and 12 months of participation have already been published elsewhere. They showed no between-group differences between the standard and enriched GLB but higher weight loss in both groups compared to the DPP. This paper reports the long-term weight loss maintenance data following participation in the program. METHODS:Of the 172 participants enrolled at the beginning of the study, data from 110 participants were available and analyzed at 24 months, i.e., 12 months after the end of the 12-month intervention. RESULTS:No between-group difference in weight loss maintenance was observed. Pooled results showed a significant weight regain from 12 to 24 months, i.e., an average of 7.85 lbs. of the 20.36 lbs. lost. However, participants from both groups were still 12.51lbs or 6.13% lighter at 24 months than at baseline. CONCLUSION:If-then plans did not result in a higher percentage of weight loss at 24-month follow-up compared to the standard GLB. However, at 24 months, both groups did show a maintenance of a significant portion of the weight lost at the end of intervention. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02008435, registered 6 December 2013.

Project description:BackgroundThe Diabetes Prevention Program (DPP) was a randomized, controlled clinical trial. It demonstrated that among high-risk individuals with impaired glucose tolerance, diabetes incidence was reduced by 58 % with lifestyle intervention and 31 % with metformin compared to placebo. During the Diabetes Prevention Program Outcomes Study (DPPOS), all DPP participants were unmasked to their treatment assignments, the original lifestyle intervention group was offered additional lifestyle support, the metformin group continued metformin, and all three groups were offered a group-implemented lifestyle intervention. Over the 10 years of combined DPP/DPPOS follow-up, diabetes incidence was reduced by 34 % in the lifestyle group and 18 % in the metformin group compared to placebo. The purpose of this article is to review and synthesize analyses published by the DPP/DPPOS Research Group that have described the cost-effectiveness of diabetes prevention.MethodsWe describe the resource utilization and costs of the DPP and DPPOS interventions, the costs of non-intervention-related medical care, the impact of the interventions on diabetes progression and quality-of-life, and the cost-effectiveness of the interventions from health system and societal perspectives. Cost-effectiveness analyses were performed with a 3-year time horizon using DPP data, a lifetime time horizon that simulated 3-year DPP data, and a 10-year time horizon using combined DPP/DPPOS data.ResultsAlthough more expensive than the placebo intervention, the greater costs of the lifestyle and metformin interventions were offset by reductions in the costs of nonintervention-related medical care. Every year after randomization, quality-of-life was better for participants in the lifestyle intervention compared to those in the metformin or placebo intervention. In both the simulated lifetime analysis and the 10-year within trial economic analysis, lifestyle and metformin were extremely cost-effective (that is, improved outcomes at a low incremental cost) or even cost-saving (that is, improved outcomes and reduced total costs) compared to the placebo intervention.ConclusionsThe implementation of diabetes prevention programs in high-risk individuals will result in important health benefits and represents a good value for money.Trial registrationNCT00004992 (DPP) and NCT00038727 (DPPOS).

Project description:BackgroundRunning is one of the most popular and accessible physical activities in the world. However, running-related injuries are unfortunately very common. Scientific evidence is limited and scarce regarding (cost-)effectiveness and implementation process of interventions for running-related injuries prevention. Thus, the objective of this study will be to investigate the effectiveness, cost-effectiveness and implementation process of a running-related injury prevention program (RunIn3).MethodsThis is the protocol of a pragmatic hybrid type 1 randomized controlled trial. There will be 530 runners over 18 years old, without running-related injuries in the last 3 months from São Paulo, Brazil. This program will be delivered online with two broad actions: (1) to provide feedback on individual training characteristics and running-related injury risk; and (2) providing/enhancing knowledge, skills and self-efficacy on running-related injury preventive behaviors. The primary outcome will be the proportion of runners reporting running-related injuries. The secondary outcomes will be preventive behaviors, direct and indirect costs, and implementation outcomes. The main effectiveness analysis on the primary outcome will be performed using linear probability mixed models in order to allow outcome changes over time and to yield the absolute risk reduction between-groups.DiscussionThe main hypothesis of this study is that the RunIn3 program will be effective in reducing the running-related injury risk and in promoting preventive behavior, either by increasing the frequency of healthy behaviors or by reducing the frequency of risk behaviors. Moreover, if the RunIn3 program is effective in reducing the running-related injuries risk, we believe that this effect would go alongside with a reduction of societal costs.Trail registrationClinicaltrials.gov (NCT03892239) Registered 5 February 2019 - Prospectively registered, https://clinicaltrials.gov/ct2/show/NCT03892239.

Project description:BackgroundProvision of anticipatory guidance for parents is recommended as an effective strategy to prevent injuries among young children. Technology-based anticipatory guidance has been suggested to reinforce the effectiveness of injury prevention and improve parents' knowledge of child safety.ObjectiveThis study aims to examine the effectiveness of a technology-based injury prevention program with parental anticipatory guidance for enhancing mothers' knowledge of child safety.MethodsIn this randomized controlled trial, 308 mothers will be recruited from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong. Participating mothers will be randomly assigned into intervention and control groups. Mothers in the intervention group will be given free access to a technology-based injury prevention program with anticipatory guidance, whereas mothers in the control group will be given a relevant booklet on parenting. The injury prevention program, available as a website or on a mobile app, includes behavioral components based on the Theory of Planned Behavior. The primary outcome measure will be the change in the mother's knowledge of child safety. The secondary outcome measures will be age-appropriate domestic safety knowledge, attitudes, intentions, perceived behavioral control, and self-reported behavior related to home safety practice. We will also determine dose-response relationships between the outcome measures and the website and mobile app usage.ResultsEnrolment of participants will begin in October 2016. Results are expected by June 2018.ConclusionsParents will be able to easily access the domestic injury prevention website to find information regarding child injury prevention. It is anticipated that the technology-based intervention will help parents improve their knowledge of child safety and raise their awareness about the consequences of domestic injuries and the importance of prevention.Trial registrationClinicaltrials.gov Clinicaltrials.gov NCT02835768; http://clinicaltrials.gov/ct2/show/NCT02835768 (Archived by WebCite at http://www.webcitation/6lbXYM6b9).

Project description:BackgroundCardiovascular disease is the leading cause of death in the United States and places substantial burden on the health care system. Rural populations, especially women, have considerably higher rates of cardiovascular disease, influenced by poverty, environmental factors, access to health care, and social and cultural attitudes and norms.Methods/designThis community-based study will be a two-arm randomized controlled efficacy trial comparing a multi-level, community program (Strong Hearts, Healthy Communities) with a minimal intervention control program (Strong Hearts, Healthy Women). Strong Hearts, Healthy Communities was developed by integrating content from three evidence-based programs and was informed by extensive formative research (e.g. community assessments, focus groups, and key informant interviews). Classes will meet twice weekly for one hour for 24 weeks and focus on individual-level skill building and behavior change; social and civic engagement are also core programmatic elements. Strong Hearts, Healthy Women will meet monthly for hour-long sessions over the 24 weeks covering similar content in a general, condensed format. Overweight, sedentary women 40 years of age and older from rural, medically underserved communities (12 in Montana and 4 in New York) will be recruited; sites, pair-matched based on rurality, will be randomized to full or minimal intervention. Data will be collected at baseline, midpoint, intervention completion, and six-month, one-year, and eighteen months post-intervention. The primary outcome is change in body weight; secondary outcomes include physiologic, anthropometric, behavioral, and psychosocial variables. In the full intervention, engagement of participants' friends and family members in partnered activities and community events is an intervention target, hypothesizing that there will be a reciprocal influence of physical activity and diet behavior between participants and their social network. Family members and/or friends will be invited to complete baseline and follow-up questionnaires about their health behaviors and environment, height and weight, and attitudes and beliefs.DiscussionStrong Hearts, Healthy Communities aims to reduce cardiovascular disease morbidity and mortality, improve quality of life, and reduce cardiovascular disease-related health care burden in underserved rural communities. If successful, the long-term goal is for the program to be nationally disseminated, providing a feasible model to reduce cardiovascular disease in rural settings.Trial registrationClinicalTrials.gov Identifier: NCT02499731 Registered on July 1, 2015.

Dataset Information

Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program.

Publications

Increasing the effectiveness of the Diabetes Prevention Program through if-then plans: study protocol for the randomized controlled trial of the McGill CHIP Healthy Weight Program.

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