SMARTer weight loss management

更智能的减肥管理

• 批准号: 10567424
• 负责人: Angela Fidler Pfammatter
• 金额: $ 69.04万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10567424
• 关键词: Address; Adult; Behavior Therapy; Behavioral; Body Weight decreased; Caring; Chronic Disease; Classification; Clinical; Cognitive; Diabetes Mellitus; Diabetes prevention; Diet; Disinhibition; Eating; Expenditure; Future; Health Care Costs; Heterogeneity; Individual; Intervention; Maintenance; Mediating; Mediator; Modeling; Neighborhoods; Obesity; Obesity Epidemic; Overweight; Participant; Patients; Policies; Population; Population Programs; Randomized; Randomized, Controlled Trials; Research; Resources; Rewards; Testing; Text Messaging; Treatment Cost; Weight; adaptive intervention; adult obesity; arm; comparison control; cost; cost comparison; cost effective; cost effectiveness; craving; deprivation; design; diabetes prevention program; economic evaluation; effective intervention; efficacy testing; emotional eating; executive function; food insecurity; head-to-head comparison; literacy; multiphase optimization strategy; negative affect; obese person; obesity management; obesity treatment; optimism; pandemic disease; patient response; programs; randomized, clinical trials; relative effectiveness; research clinical testing; response; restraint; smartphone application; standard care; standard of care; treatment as usual; treatment responders; treatment response; trial comparing; weight loss intervention

Project Summary This application proposes to compare an optimized, resource-efficient, adaptive obesity treatment against a gold-standard fixed treatment package and assessment only control. The obesity pandemic continues unabated, presaging an onslaught of diabetes. Despite numerous initiatives, gold standard Diabetes Prevention Program (DPP) intensive multicomponent behavioral treatment for overweight and obesity remains too expensive, burdensome, and difficult to scale to suggest that it can be provided to the 2/3 of the population that needs to lose weight. To address this challenge, we strive to optimize less burdensome treatment approaches that can maximize weight loss in the population that has obesity with reduced resource expenditure. In the SMART Weight Loss Management trial, we randomly assigned 400 adults with overweight/obesity to a stepped care weight loss intervention in which first line treatment was either 1) a smartphone app alone (App) or 2) the app plus coaching (App + C). Participants who did not attain adequate weight loss (i.e., averaging >0.5 lb/week) were classified as nonresponders, and re-randomized to be stepped up by a modest or vigorous addition of treatment components. Preliminary Results showed that: 1) More patients achieved clinically meaningful 6 month weight loss with App + C than App; 2) App + C non-responders who adhered to the vigorous step-up (text message and meal replacement) lost as much weight as responders by 12-months. These compelling findings point to a need to test the efficacy of SMARTER stepped-care intervention in a randomized controlled trial. The SMARTer trial is a three-arm, non-inferiority randomized controlled trial that compares the optimized, adaptive SMARTer intervention against gold-standard DPP and Control. The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at less cost. If so, we will emerge with a scalable, effective intervention that tailors to patient response using a stepped-care model. Alongside evaluation of clinical non- inferiority, a comprehensive economic analysis will inform relative affordability and scalability. Hypotheses are that: 1) SMARTer stepped-care will be non-inferior to gold standard DPP in its effect on 6 month weight loss; and 2) The SMARTer intervention will be more cost-effective to implement. We will explore whether extending the SMARTer intervention results in weight loss maintenance at 12 months compared to DPP and Control. Lastly, we will explore mediators and moderators of SMARTer's effect on weight loss to inform future intervention optimization. If successful, findings will support dissemination of a cost-effective obesity population management strategy that facilitates treating obesity with the resources it needs – not more, and not less.

项目概要 该应用旨在将优化的、资源高效的、适应性肥胖治疗与 金标准固定治疗方案和评估仅控制肥胖流行病仍在继续。 尽管采取了许多举措，但糖尿病的黄金标准仍未减弱。 预防计划（DPP）针对超重和肥胖的强化多成分行为治疗仍然存在 过于昂贵、繁琐且难以扩展，无法向 2/3 的人口提供 为了应对这一挑战，我们努力优化减轻负担的治疗。 可以在资源减少的情况下最大限度地减轻肥胖人群体重的方法 在 SMART 减肥管理试验中，我们随机分配了 400 名成年人。 超重/肥胖采取阶梯式护理减肥干预措施，其中一线治疗是 1) a 单独的智能手机应用程序 (App) 或 2) 应用程序加辅导 (App + C) 未达到足够水平的参与者。 体重减轻（即平均>0.5磅/周）被归类为无反应者，并重新随机分组 初步结果表明：1）更多。 使用 App + C 的患者比使用 App + C 无反应的患者实现了具有临床意义的 6 个月体重减轻； 坚持积极加强（短信和代餐）的人减掉的体重与响应者一样多 这些令人信服的发现表明需要测试 SMARTER 分级护理的功效。 SMARTer 试验是一项三组、非劣效性随机试验。 对照试验，将优化的自适应 SMARTer 干预与黄金标准 DPP 进行比较 该试验将探讨可扩展的阶梯式护理干预措施是否能够达到黄金标准。 DPP 通过以更低的成本实现类似的减肥效果 如果是这样，我们将推出可扩展的、有效的方案。 使用分级护理模式进行针对患者反应的干预措施，同时评估临床非症状。 劣势，全面的经济分析将相对告知可承受性和可扩展性。 1) SMARTer 阶梯护理对 6 个月减肥的效果不逊色于黄金标准 DPP； 2) SMARTer 干预措施的实施将更具成本效益，我们将探讨是否扩展。 与 DPP 和对照相比，SMARTer 干预可在 12 个月时维持体重减轻。 最后，我们将探讨 SMARTer 对减肥效果的中介因素和调节因素，为未来提供信息 如果成功，研究结果将支持传播具有成本效益的肥胖人群。 促进利用所需资源治疗肥胖的管理策略——不多也不少。