Recruitment and retention strategies for weight management trial - Clinical Study Strategies

Nutrition Research Newsletter, Feb, 2004

Clinical trials conducted in research settings have clearly shown that current state-of-the-art lifestyle interventions for weight management in type 2 diabetes are efficacious in terms of both weight loss and the improvement of metabolic control. However, most were conducted in urban settings and included small percentages of ethnically diverse individuals, limiting the ability of the results to be generalized to African-Americans and rural communities. Strategies for Weight Management in Type 2 Diabetes: Pounds Off with Empowerment (POWER) is a randomized clinical trial designed to evaluate the efficacy and effectiveness of translating a research-based, state-of-the-art weight management intervention for people with type 2 diabetes, to clinical settings in medically underserved communities in rural South Carolina.

Partnering with community health centers was central to the recruitment strategy. The project was marketed to physicians, health center staff, and patients. The screening procedures and recruitment strategies were similar to those used in successful studies previously funded by the National Institutes of Health. The staged recruitment process included (a) medical record review, (b) a prescreening telephone call, (c) two screening visits, and (d) a randomization visit.

Adult subjects greater than or equal to 45 years of age with clinically diagnosed diabetes who were seen at the health center during the prior calendar year were identified. A medical record review was conducted to confirm diagnosis, age, and overweight status. Eligible subjects (n=1,106) received a personalized letter, and were followed-up by a telephone call. No more than 5 attempts were made to contact each subject. The 20-minute telephone eligibility prescreening was conducted to provide subjects with details about the study, to address questions, to obtain additional information on health status, and to invite participation. Screening visit 1 was designed to learn more about the subjects' medical history, medication use and current health status. The purpose of screening visit 2 was to describe full study participation, complete a dietary and physical activity assessment, and provide run-in instructions. Overall, 189 subjects were randomized into one of three study conditions: intensive lifestyle, reimbursable lifestyle, and usual care.

Lifestyle intervention was based on the Lifestyle Change program curriculum of the National Institutes of Health/National Institute of Diabetes Digestive and Kidney Diseases-funded primary prevention trial--the Diabetes Prevention Program (DPP). It consisted of a reduction in fat/ calorie intake, increased activity, frequent contact with a nutritionist, self-monitoring, and other strategies for sustained behavior change. As in the DPP, the POWER nutritionists were the cornerstone of the intervention, involved in every phase. Randomized subjects completed three standard visits at 3 months, 6 months, and 12 months, to asses the impact of the interventions on the primary outcome of weight, and the secondary outcomes of metabolic status, fasting glucose concentrations, glycated hemoglobin, lipoprotein profile, blood pressure, and microalbuminuria.

During recruitment, the subjects received monetary incentives immediately after completing screening visit 1 and randomization. No incentives were given at visit 2. The incentive value was relatively small ($10 gift certificates to a local grocery store after visit 1, and $25 after randomization). Monetary incentives were also used to enhance retention during the 12-month follow-up. Subjects received a $25 pharmacy gift certificate and a refrigerator magnet with study logo at 3 months, and a $20 grocery store gift certificate plus a study t-shirt at 6 months, and a $20 grocery store gift certificate plus a cookbook at 12 months.

This study population required substantial human and monetary resources to recruit and retain. The most successful recruitment and retention strategies used in POWER included: partnerships with community health centers; hiring staff from the community; marketing to physicians, staff and patients; staging recruitment and information consent processes; monitoring progress; providing transportation; and using positive reinforcement and social supportiveness. Retention at 12 months was 81.5%. This work provides a useful example of an academic-community partnership designed to reach groups previously considered hard to reach.

D. Parra-Medina, A. D 'Antonio, S. Smith, et al. Successful recruitment and retention strategies for a randomized weight management trial for people with diabetes living in rural, medically underserved counties of south carolina: The POWER Study. JADA 104:70-75 (January 2004) [Correspondence: Deborah Parra-Medina, PhD, University of South Carolina, Department of Health Promotion, Education, and Behavior, Norman J. Arnold School of Public Health, and Department of Women's Studies, University of South Carolina, Columbia, SC 29208. E-mail: dpmedina@sc.edu.]