SMARTer weight loss management

项目摘要 本申请提出将优化的、资源有效的、适应性肥胖治疗与优化的、资源有效的、适应性肥胖治疗进行比较。 金标准固定治疗包和评估仅控制。肥胖症的流行仍在继续 而且势头不减，预示着糖尿病的爆发尽管有许多倡议，黄金标准糖尿病 预防计划（DPP）针对超重和肥胖症的强化多组分行为治疗仍然存在 太昂贵，负担太重，而且很难扩大规模，以至于无法向2/3的人口提供 需要减肥的人为了应对这一挑战，我们努力优化负担较轻的治疗 方法，可以最大限度地减轻体重的人口有肥胖与减少资源 支出在SMART减肥管理试验中，我们随机分配了400名成年人， 将超重/肥胖患者分为阶梯式护理减肥干预组，其中一线治疗为：1） 单独的智能手机应用程序（App）或2）应用程序加辅导（App + C）。未达到适当水平的参与者 体重减轻（即，平均>0.5磅/周）被归类为无应答者，并重新随机化以进行逐步 通过适度或剧烈地添加处理组分而增加。Preliminary Results shows that：1）更多 与App相比，App + C组患者实现了具有临床意义的6个月体重减轻; 2）App + C无应答者 那些坚持大力加强（短信和代餐）的人减掉的体重和响应者一样多 12个月。这些令人信服的发现表明，需要测试SMARTER阶梯式护理的有效性 干预随机对照试验。SMARTer试验是一项三组、非劣效性、随机 对照试验，比较优化的自适应SMARTer干预与金标准DPP， 控制该试验将解决可扩展的阶梯式护理干预是否能够达到黄金标准 DPP通过以更低的成本实现可比的重量损失。如果是这样，我们将出现一个可扩展的，有效的 使用阶梯式护理模式根据患者反应进行定制的干预。除了评估临床非 但是，如果我们的产品质量低劣，那么一个全面的经济分析将为相对的可承受性和可扩展性提供信息。假设是 1）SMARTer阶梯护理在6个月的减肥效果方面不劣于金标准DPP; （2）SMART干预措施的实施将更具成本效益。我们将探讨是否延长 与DPP和对照相比，SMARTer干预导致在12个月时维持体重减轻。 最后，我们将探讨SMARTer对减肥效果的中介者和调节者，以告知未来 干预优化如果成功，研究结果将支持成本效益肥胖人群的传播 管理战略，促进治疗肥胖的资源，它需要-不多，也不少。

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.