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项目 STAR 的设计:一项随机对照试验,评估适应性干预对长期减肥维持的影响。

Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance.

机构信息

Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.

Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.

出版信息

Contemp Clin Trials. 2024 Nov;146:107707. doi: 10.1016/j.cct.2024.107707. Epub 2024 Oct 9.

DOI:10.1016/j.cct.2024.107707
PMID:39384066
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11566105/
Abstract

BACKGROUND

Without provision of additional intervention, most individuals regain weight after the end of weight-loss programs. Extended-care programs have been demonstrated to improve long-term weight-loss maintenance, but effects are modest.

METHODS

We proposed to evaluate whether delivering extended-care telephone sessions on an ADAPTIVE (provided when individuals are deemed to be at high-risk for weight regain) versus STATIC (the once-per-month schedule typically used in extended-care programs) schedule improves weight regain after initial weight loss. Adults with obesity were initially recruited for a 16-week lifestyle weight-loss program, and those who lost ≥5 % of their initial weight were eligible for enrollment in the Project STAR maintenance trial.

RESULTS

A total of 449 individuals (mean ± SD age = 49.5 ± 11.4 years, BMI = 35.7 ± 4.0 kg/m, 83.5 % female, 23.4 % Black or African American, 9.8 % Hispanic) were recruited for the initial weight-loss program and lost an average of 6.4 ± 4.9 % of their initial body weight; 255 were randomized to the maintenance trial. There were no significant differences between participants randomized to the trial versus those who were not in terms of baseline weight, gender, race/ethnicity, education, or marital status, all ps > 0.05; however, participants who were randomized to the trial were older, p = .014, and reported higher incomes, p < .001.

CONCLUSION

Results from Project STAR will demonstrate whether providing extended-care intervention on an individually adaptable schedule improves long-term weight-loss maintenance. Moreover, the rich longitudinal dataset collected during the trial will serve as a foundation for building future predictive algorithms of weight regain and novel weight-maintenance interventions.

摘要

背景

大多数人在减肥计划结束后体重会反弹,如果不提供额外的干预措施。延长护理计划已被证明可以改善长期的减肥维持效果,但效果有限。

方法

我们提出评估在适应性(当个体被认为有体重反弹的高风险时提供)与静态(延长护理计划中常用的每月一次的时间表)方案下提供延长护理电话会议是否会改善初始体重减轻后的体重反弹。肥胖成年人最初参加了为期 16 周的生活方式减肥计划,那些体重减轻≥5%的人有资格参加 STAR 维持试验。

结果

共有 449 名参与者(平均年龄±标准差为 49.5±11.4 岁,BMI=35.7±4.0kg/m,83.5%为女性,23.4%为黑人和非洲裔美国人,9.8%为西班牙裔)被招募参加初始体重减轻计划,平均减轻初始体重的 6.4±4.9%;255 人被随机分配到维持试验中。在基线体重、性别、种族/民族、教育程度或婚姻状况方面,随机分配到试验组的参与者与未分配到试验组的参与者之间没有显著差异,所有 p 值均>0.05;然而,随机分配到试验组的参与者年龄较大,p=0.014,收入较高,p<0.001。

结论

STAR 项目的结果将表明,根据个体适应性计划提供延长护理干预是否可以改善长期减肥维持效果。此外,试验期间收集的丰富纵向数据集将为建立体重反弹和新型体重维持干预措施的预测算法奠定基础。

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