BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences.
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.
['Sherwood|Nancy E|NE|0000-0002-3365-9018', 'Crain|A Lauren|AL|', 'Seburg|Elisabeth M|EM|', 'Butryn|Meghan L|ML|', 'Forman|Evan M|EM|0000-0001-7233-1384', 'Crane|Melissa M|MM|', 'Levy|Rona L|RL|', 'Kunin-Batson|Alicia S|AS|', 'Jeffery|Robert W|RW|']
Weight loss Intervention Adults Obesity