Contemporary Clinical Trials Communications (Sep 2021)
Protocol and short-term results for a feasibility randomized controlled trial of a video intervention for Veterans with obesity: The TOTAL (Teaching Obesity Treatment Options to Adult Learners) pilot study
Abstract
Introduction: All three evidence-based treatment options for adults with severe obesity – behavioral weight management, weight management medications (WMM), and bariatric surgery – are underutilized in the Veterans Health Administration (VHA) system. Our objective in this study was to develop and pilot-test the TOTAL (Teaching Obesity Treatment Options to Adult Learners) intervention, which seeks to increase Veteran participation in obesity treatment. Methods: In this single-site, parallel, pilot RCT, Veterans with severe obesity with an upcoming behavioral weight management visit were sent a recruitment letter after meeting inclusion/exclusion criteria via electronic health record screening. Eligible Veterans were randomized to TOTAL or usual care. TOTAL consisted of an 18-min video highlighting obesity health risks and treatment outcomes, eligibility criteria, and pros/cons of all three evidence-based obesity treatments. The primary outcomes were trial design feasibility (recruitment and retention rates) and acceptability to Veterans, which was assessed via semi-structured interviews with participants one week after randomization to TOTAL. Secondary outcomes included attitudes and self-efficacy to initiate treatment one week post-randomization and BMI change six months post-randomization (assessed via Cohen's d). Results: Forty-two Veterans were randomized (recruitment rate = 47.2%), and 40/42 completed one-week assessments (retention rate = 95.2%). The mean participant age was 59.2 ± 11.9 years. Female and non-White participants comprised 14.3% and 11.9% of the cohort, respectively. Semi-structured interviews with all 20 participants who received TOTAL suggested that the delivery logistics and content of TOTAL were acceptable to Veterans. Attitudes toward behavioral weight management and bariatric surgery and weight loss improved in TOTAL vs. usual care patients (Cohen's d ranging from 0.3 to 0.6). Conclusions: TOTAL was feasible to implement, acceptable to Veterans, and has the potential to increase obesity treatment participation in VHA. An adequately powered RCT is warranted to assess its impact on population-level weight loss. Trial registration: ClinicalTrials.gov NCT03856320.
