Design and Methods of diaBEAT-it!: A Hybrid Preference/Randomized Control Trial Design using the RE-AIM Framework

摘要

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. This study uses a unique hybrid design that allows an assessment of reach by providing participants choice between interventions and an assessment of effectiveness and cost using a standard randomized controlled trial (RCT). 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. 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.