Nancy E Sherwood, A Lauren Crain, Elisabeth M Seburg, Meghan L Butryn, Evan M Forman, Melissa M Crane, Rona L Levy, Alicia S Kunin-Batson, Robert W Jeffery
{"title":"BestFIT顺序多重分配随机试验结果:一种开发个性化减肥治疗序列的SMART方法。","authors":"Nancy E Sherwood, A Lauren Crain, Elisabeth M Seburg, Meghan L Butryn, Evan M Forman, Melissa M Crane, Rona L Levy, Alicia S Kunin-Batson, Robert W Jeffery","doi":"10.1093/abm/kaab061","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Purpose: </strong>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).</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trial information: </strong>ClinicalTrials.gov identifier; NCT02368002.</p>","PeriodicalId":520558,"journal":{"name":"Annals of behavioral medicine : a publication of the Society of Behavioral Medicine","volume":" ","pages":"291-304"},"PeriodicalIF":0.0000,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8887581/pdf/kaab061.pdf","citationCount":"4","resultStr":"{\"title\":\"BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences.\",\"authors\":\"Nancy E Sherwood, A Lauren Crain, Elisabeth M Seburg, Meghan L Butryn, Evan M Forman, Melissa M Crane, Rona L Levy, Alicia S Kunin-Batson, Robert W Jeffery\",\"doi\":\"10.1093/abm/kaab061\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Purpose: </strong>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).</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trial information: </strong>ClinicalTrials.gov identifier; NCT02368002.</p>\",\"PeriodicalId\":520558,\"journal\":{\"name\":\"Annals of behavioral medicine : a publication of the Society of Behavioral Medicine\",\"volume\":\" \",\"pages\":\"291-304\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8887581/pdf/kaab061.pdf\",\"citationCount\":\"4\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of behavioral medicine : a publication of the Society of Behavioral Medicine\",\"FirstCategoryId\":\"102\",\"ListUrlMain\":\"https://doi.org/10.1093/abm/kaab061\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of behavioral medicine : a publication of the Society of Behavioral Medicine","FirstCategoryId":"102","ListUrlMain":"https://doi.org/10.1093/abm/kaab061","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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.
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