Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial.

Adults with mobility related disabilities (MRDs) represent an underserved group with a high prevalence of overweight/obesity and limited options for weight management. We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity. However, the costs/logistics associated with intervention delivery by individual home visits limits the potential for scaling and implementation of this approach. Thus, we will conduct a two-arm randomized trial in 128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing. The primary aim will compare weight loss between interventions arms across 6 months. Secondarily, we will compare weight loss (0-18 mos.), the proportion of participants who achieve clinically meaningful weight loss (≥5%) from 0 to 6 and 0 to18 months, and changes in quality of life from 0 to 6 and 0 to 18 months between interventions arms. We will also conduct cost, cost-effectiveness and contingent valuation comparisons and explore the influence of behavioral session attendance, compliance with the recommendations for diet and physical activity, self-monitoring of diet and physical activity, barriers to physical activity, sleep quality, and medications on weight change across 6 and 18 months. NCT REGISTRATION: NCT04046471.

RCT Entities:   Population Interventions Outcomes