Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance

BACKGROUND: Behavioral interventions for obesity produce clinically meaningful weight loss, but weight regain following treatment is common. Extended care programs attenuate weight regain and improve weight loss maintenance. However, less is known about the most effective ways to deliver extended care, including contact schedules. METHODS: We compared the 12-month weight regain of an extended care program utilizing a non-conventional, clustered campaign treatment schedule and a self-directed program among individuals who previously achieved ≥5% weight reductions. Participants (N = 108; mean age = 51.6 years; mean weight = 92.6 kg; 52% African American; 95% female) who achieved ≥5% weight loss during an initial 16-week behavioral obesity treatment were randomized into a 2-arm, 12-month extended care trial. A clustered campaign condition included 12 group-based visits delivered in three, 4-week clusters. A self-directed condition included provision of the same printed intervention materials but no additional treatment visits. The study was conducted in a U.S. academic medical center from 2011 to 2015. RESULTS: Prior to randomization, participants lost an average of −7.55 ± 3.04 kg. Participants randomized to the 12-month clustered campaign program regained significantly less weight (0.35 ± 4.62 kg) than self-directed participants (2.40 ± 3.99 kg), which represented a significant between-group difference of 2.28 kg (p = 0.0154) after covariate adjustments. This corresponded to maintaining 87% and 64% of lost weight in the clustered campaign and self-directed conditions, respectively, which was a significant between-group difference of 29% maintenance of lost weight after covariate adjustments, p = 0.0396. CONCLUSIONS: In this initial test of a clustered campaign treatment schedule, this novel approach effectively promoted 12-month maintenance of lost weight. Future trials should directly compare the clustered campaigns with conventional (e.g., monthly) extended care schedules. TRIAL REGISTRATION: Clinicaltrials.gov NCT02487121. Registered 06/26/2015 (retrospectively registered)