BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences. Issue 3 (20th August 2021)

• Record Type: Journal Article
• Authors: Sherwood, Nancy E; Crain, A Lauren; Seburg, Elisabeth M; Butryn, Meghan L; Forman, Evan M; Crane, Melissa M; Levy, Rona L; Kunin-Batson, Alicia S; Jeffery, Robert W
• Is Part Of: Annals of behavioral medicine. Volume 56:Issue 3(2022)
• Page Start: 291
• Page End: 304
• Publication Date: 2021-08-20
• Subjects: Obesity -- Intervention -- Weight loss -- Adults; Medicine and psychology -- Periodicals; Sick -- Psychology -- Periodicals; Behavioral Medicine; 616.0019
• DOI: 10.1093/abm/kaab061
• Languages: English
• ISSNs: 0883-6612

Abstract

Abstract: Background: State-of-the-art behavioral weight loss treatment (SBT) can lead to clinically meaningful weight loss, but only 30–60% achieve this goal. Developing adaptive interventions that change based on individual progress could increase the number of people who benefit. Purpose: Conduct a Sequential Multiple Assignment Randomized Trial (SMART) to determine the optimal time to identify SBT suboptimal responders and whether it is better to switch to portion-controlled meals (PCM) or acceptance-based treatment (ABT). Method: The BestFIT trial enrolled 468 adults with obesity who started SBT and were randomized to treatment response assessment at Session 3 (Early TRA) or 7 (Late TRA). Suboptimal responders were re-randomized to PCM or ABT. Responders continued SBT. Primary outcomes were weight change at 6 and 18 months. Results: PCM participants lost more weight at 6 months (−18.4 lbs, 95% CI −20.5, −16.2) than ABT participants (−15.7 lbs, 95% CI: −18.0, −13.4), but this difference was not statistically significant (−2.7 lbs, 95% CI: −5.8, 0.5, p = .09). PCM and ABT participant 18 month weight loss did not differ. Early and Late TRA participants had similar weight losses ( p = .96), however, Early TRA PCM participants lost more weight than Late TRA PCM participants ( p = .03). Conclusions: Results suggest adaptive intervention sequences that warrant further research (e.g., identify suboptimal responders at Session 3, use PCMs as second-stage treatment). Utilizing the SMART methodology to develop an adaptive weight loss intervention that would outperform gold standard SBT in a randomized controlled trial is an important next step, but may require additional optimization work. Clinical Trial information: ClinicalTrials.gov identifier; NCT02368002 Abstract : This study examined whether it was better to identify weight loss treatment suboptimal responders at Session 3 or 7 and whether portion-controlled meals or acceptance-based treatment was more effective. Results showed no weight loss difference between Session 3 and 7 participants or the second-stage treatments.