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

Abstract

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.

Keywords: DVD; Diabetes prevention; Hybrid design; IVR; RE-AIM; Weight loss.

Figure 1

diaBEAT-it Trial: Consort diagram of procedures for the hybrid preference/randomized controlled trial design and RE-AIM considerations *Adoption is operationalized as the proportion and representativeness of clinics and physicians that agree to refer patients to the study.