Design and methods of "diaBEAT-it!": a hybrid preference/randomized control trial design using the RE-AIM framework.

BACKGROUND: Diabetes prevention is a public health priority that is dependent upon the reach, effectiveness, and cost of intervention strategies. However, understanding each of these outcomes within the context of randomized controlled trials is problematic. PURPOSE: To describe the methods and design of a hybrid preference/randomized control trial using the RE-AIM framework. METHODS: The trial, which was developed using the RE-AIM framework, will contrast the effects of 3 interventions: (1) a standard care, small group, diabetes prevention education class (SG), (2) the small group intervention plus 12 months of interactive voice response telephone follow-up (SG-IVR), and (3) a DVD version of the small group intervention with the same IVR follow-up (DVD-IVR). Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the Diabetes Prevention Program (DPP). Adult patients at risk for diabetes will be randomly assigned to either choice or RCT. Those assigned to choice (n=240) will have the opportunity to choose between SG-IVR and DVD-IVR. Those assigned to RCT group (n=360) will be randomly assigned to SG, SG-IVR, or DVD-IRV. Assessment of primary (weight loss, reach, & cost) and secondary (physical activity, & dietary intake) outcomes will occur at baseline, 6, 12, and 18 months. CONCLUSION: This will be the first diabetes prevention trial that will allow the research team to determine the relationships between reach, effectiveness, and cost of different interventions.

Beginning a patient-centered approach in the design of a diabetes prevention program.

OBJECTIVE: The purpose of this study was to identify patient preferences for different components of a local diabetes prevention program that would improve reach. A secondary purpose was to determine if patient characteristics were related to program preferences. METHODS: Participants were identified through electronic medical records from two family medicine clinics in Virginia. Participants completed a mailed survey addressing demographics, economic status, risk factors for diabetes, and preferences regarding diabetes prevention interventions-delivery mode, program length, and duration. RESULTS: Twenty-nine percent of eligible participants responded (n = 142); 83% of participants were at risk for diabetes and 82% had a household income <$20,000. When presented with the choice between a class-based vs. a technology-based program, 83% preferred a technology-based program. Whites were less likely to choose the technology-based program, with no significant differences based on age, education, income, or gender. CONCLUSIONS: Contrary to beliefs that lower income individuals may not use technology-based interventions, lower socioeconomic patients indicated a preference for a technology- and telephone-supported diabetes prevention program over in-person class approaches. Findings provide formative data to support the design of a patient-centered, technology-enhanced diabetes prevention program in a real-world setting, thereby increasing potential participation and reach.