BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences.
BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences.
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BestFIT 序贯多重分配随机试验结果：开发个体化减肥治疗序列的明智方法。
DOI：
10.1093/abm/kaab061
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发表时间：
2022
期刊：
影响因子：
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通讯作者：
Jeffery,RobertW
中科院分区：
文献类型：
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作者：
Sherwood,NancyE;Crain,ALauren;Seburg,ElisabethM;Butryn,MeghanL;Forman,EvanM;Crane,MelissaM;Levy,RonaL;Kunin-Batson,AliciaS;Jeffery,RobertW
最先进的行为减肥治疗（SBT）可以导致临床上有意义的体重减轻，但只有30-60%的人达到了这一目标。根据个人进步制定适应性干预措施，可以增加受益人数。目的：进行一项顺序多任务随机试验（SMART），以确定识别SBT次优应答者的最佳时间，以及切换到部分控制膳食（PCM）或基于接受度的治疗（ABT）是否更好。BestFIT试验招募了468名开始SBT的肥胖成人，并随机分为第3期（TRA早期）和第7期（TRA晚期）进行治疗反应评估。次优应答者被重新随机分配到PCM或ABT，应答者继续SBT。主要结局是6个月和18个月时的体重变化。结果spcm参与者在6个月时体重减轻（- 18.4磅，95% CI: - 20.5, - 16.2）比ABT参与者（- 15.7磅，95% CI: - 18.0, - 13.4）更多，但这种差异没有统计学意义（- 2.7磅，95% CI: - 5.8, 0.5,p= .09）。PCM和ABT参与者18个月的体重减轻没有差异。早期和晚期TRA参与者有相似的体重减轻（p= .96），然而，早期TRA PCM参与者比晚期TRA PCM参与者减轻的体重更多（p= .03）。结果表明适应性干预序列值得进一步研究（例如，在第3阶段确定次优应答者，使用PCMs作为第二阶段治疗）。在随机对照试验中，利用SMART方法开发一种优于黄金标准SBT的适应性减肥干预措施是下一步重要的工作，但可能需要额外的优化工作。临床试验信息clinicaltrials .gov标识符；NCT02368002
BackgroundState-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.PurposeConduct 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).MethodThe 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.ResultsPCM 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).ConclusionsResults 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 informationClinicalTrials.gov identifier; NCT02368002