(P30-041-24) Protocol for Weight Inclusive and Adaptive Strategies to Enhance (WISE) Cardiometabolic Health in Black Adults: A Pilot Sequential Multiple Assignment Randomized Trial

Objectives: The use of behavioral weight loss interventions is currently being challenged both by newly approved pharmacological treatments for obesity as well as increasingly popular concepts related to body positivity and weight-neutral intervention approaches. There are gaps in knowledge regarding interactions of health behaviors with pharmacological or medical approaches as well as the comparative effectiveness of weight-focused and weight-neutral strategies for improving cardiometabolic health in people with obesity. These issues are especially salient among Black adults living in the Deep South due to well-documented disparities and inequities in obesity and weight-related cardiometabolic disease. WISE Health is a pilot Sequential Multiple Assignment Randomized Trial (SMART) designed to provide clinical trial feasibility and preliminary effectiveness data of weight-focused vs. weight-neutral adaptive biobehavioral interventions for improving cardiometabolic health.

Methods: This 26-week pilot SMART will be conducted in 60 Black adults with Stage 1 Obesity (BMI ≥ 27 kg/m² and elevated plasma glucose, elevated blood pressure, and/or dyslipidemia). Participants will initially be randomly assigned to either weight-focused or weight-neutral health coaching that will address nutrition, exercise, sleep, and social support. At week 8, participants will be identified as responders or non-responders (NR) to first stage interventions based on intervention-specific response criteria of ≥3% weight loss (weight-focused) or engaging in ≥150 min/wk of moderate physical activity (weight-neutral). NR will be re-randomized to either intensified lifestyle-based strategies or enhanced medical management with their primary care providers.

Results: N/A

Conclusions: The primary aim of WISE Health is to determine the feasibility of conducting a future full-scale pragmatic SMART in a primary care setting. Preliminary effect sizes for first and second stage treatments and embedded adaptive interventions will also be measured. Using rigorous mixed-methods research, WISE Health will facilitate the development of adaptive biobehavioral strategies that can be delivered in partnership with primary care to improve cardiometabolic health in Black adults living with Stage 1 Obesity.

Funding Sources: NIMHD (P50MD017338-03S1) and NIDDK (P30DK056336)