SMARTer weight loss management

项目摘要 此应用程序建议将优化、资源高效、适应性肥胖治疗与 金标固定治疗套餐，仅限评估对照。肥胖大流行仍在继续 有增无减，预示着糖尿病的来袭。尽管有许多举措，但糖尿病的黄金标准 预防计划(DPP)对超重和肥胖的强化多成分行为治疗仍然存在 太昂贵，负担太大，难以扩大规模，以至于无法向三分之二的人口提供 这需要减肥。为了应对这一挑战，我们努力优化负担较轻的治疗方法 可以在资源减少的情况下最大限度地减轻肥胖人群的体重的方法 支出。在SMART减肥管理试验中，我们随机将400名成年人分配给 超重/肥胖到阶梯式护理减肥干预，其中一线治疗是1) 仅智能手机应用程序(App)或2)应用程序加教练(App+C)。没有达到足够成绩的参与者 体重减轻(即平均0.5磅/周)被归类为无反应者，并重新随机化以步进式 通过适量或大量添加治疗成分来提高。初步结果表明：1)较多 与App相比，使用App+C的患者实现了临床上有意义的6个月体重减轻；2)App+C无反应者 坚持剧烈运动的人(发短信和代餐)减掉了和应答者一样多的体重 到12个月前。这些令人信服的发现表明，有必要测试更智能的阶梯式护理的有效性 干预：一项随机对照试验。更聪明的试验是一项三臂、非自卑的随机试验 对照试验，将优化的、自适应的、更智能的干预与黄金标准的DPP和 控制室。这项试验将讨论可扩展的阶梯式护理干预是否能经得起黄金标准的考验 DPP通过以更低的成本实现同等的减肥效果。如果是这样的话，我们将出现一个可扩展的、有效的 使用分级护理模式根据患者反应量身定做的干预措施。同时评估临床上的非 劣势，全面的经济分析将提供相对的可负担性和可扩展性。假设是 1)更聪明的阶梯式护理在6个月减肥效果上不逊于黄金标准DPP； 2)实施更明智的干预将更具成本效益。我们将探索扩展 与DPP和对照组相比，更智能的干预措施可以在12个月内保持减肥效果。 最后，我们将探索SMARTER在减肥方面的中介和主持人，以告知未来 干预优化。如果成功，研究结果将支持成本效益高的肥胖人群的传播。 一种管理战略，有助于利用肥胖所需的资源--不是更多，也不是更少--来治疗肥胖症。

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.