Reaching high-risk Black adults for diabetes prevention programming during a pandemic: The design of Fit & Faithful a randomized controlled community trial

Obesity is a key risk factor for Type 2 diabetes (T2D). Alarmingly, 87% of US adults have overweight or obesity, with non-Hispanic black adults having higher obesity and T2D prevalence than non-Hispanic white. The Diabetes Prevention Program (DPP) demonstrated the clinical benefits of lifestyle intervention (LI). While the DPP LI is effective, some participants don't achieve clinically significant weight loss in the current group-based translation paradigm. Black adults have the lowest adjusted weight loss (3.2%) among all racial/ethnic groups. Early intervention nonresponse defined as ≤1% weight loss at intervention week 4 is linked to lower probability of achieving weight loss goals. This paper describes the design and methods of a cluster randomized controlled trial among black weight loss nonresponders nested in 20 community sites (primarily churches). Descriptions of the adaptations made to transition the program to virtual format during the COVID-19 pandemic are also included. Trained community health workers deliver a group-based, 6-month long DPP over 18 sessions via Zoom. Additionally, nonresponders in the enhanced group receive weekly telephone support to provide individual-level intervention to help overcome weight loss barriers. Outcomes include weight, physical activity level, blood pressure, and dietary behaviors; these are compared between nonresponders in the enhanced intervention group and nonresponders in the active control group. Cost, mediators, and moderators are explored. If found to efficacious, these enhanced strategies could be standardized as a supplement for use with DPP nonresponders.