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BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight
Nancy E Sherwood1, A Lauren Crain2, Elisabeth M Seburg2
1Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
Summary
Adaptive behavioral weight loss treatment (SBT) shows promise. Early identification of suboptimal responders and switching to portion-controlled meals (PCM) may enhance weight loss outcomes in obesity treatment.
Area of Science:
- Obesity research
- Behavioral medicine
- Clinical trial methodology
Background:
- Standard behavioral weight loss treatment (SBT) achieves clinically significant weight loss in only 30-60% of individuals.
- Adaptive interventions, tailored to individual progress, could improve treatment efficacy.
- The BestFIT trial investigated optimizing SBT through adaptive strategies.
Purpose of the Study:
- To determine the optimal timing for identifying individuals not responding well to SBT.
- To compare switching to portion-controlled meals (PCM) versus acceptance-based treatment (ABT) for suboptimal responders.
- To evaluate adaptive intervention strategies within a Sequential Multiple Assignment Randomized Trial (SMART) framework.
Main Methods:
- The BestFIT trial enrolled 468 adults with obesity starting SBT.
- Participants were randomized for treatment response assessment at Session 3 (Early TRA) or Session 7 (Late TRA).
- Suboptimal responders were re-randomized to PCM or ABT; responders continued SBT. Weight change was assessed at 6 and 18 months.
Main Results:
- Portion-controlled meals (PCM) showed a trend towards greater weight loss at 6 months compared to acceptance-based treatment (ABT) (p = .09).
- No significant difference in weight loss was observed between PCM and ABT at 18 months.
- Early treatment response assessment (TRA) combined with PCM led to greater weight loss than late assessment with PCM (p = .03).
Conclusions:
- Adaptive intervention strategies, such as early identification of suboptimal responders and switching to PCM, warrant further investigation for obesity treatment.
- The Sequential Multiple Assignment Randomized Trial (SMART) methodology is valuable for developing and optimizing adaptive weight loss interventions.
- Future research should focus on refining adaptive sequences to potentially outperform standard behavioral weight loss treatment.
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