1. BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences
- Author
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Meghan L. Butryn, Alicia Kunin-Batson, Evan M. Forman, A. Lauren Crain, Rona L. Levy, Robert W. Jeffery, Elisabeth M. Seburg, Nancy E. Sherwood, and Melissa M. Crane
- Subjects
Adult ,Treatment response ,medicine.medical_specialty ,law.invention ,Randomized controlled trial ,Behavior Therapy ,Weight loss ,law ,Weight Loss ,Humans ,Medicine ,Obesity ,Lead (electronics) ,General Psychology ,Motivation ,business.industry ,Weight change ,Gold standard (test) ,Time optimal ,Clinical trial ,Psychiatry and Mental health ,Treatment Outcome ,Physical therapy ,medicine.symptom ,business ,Regular Articles - 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
- Published
- 2021