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.

项目摘要 该申请提案，以比较优化，资源效率，适应性肥胖的治疗 金色标准的固定治疗套餐和仅评估控制。肥胖大流行仍在继续 不减弱，预示着糖尿病的猛攻。尽管有许多举措，但金标准糖尿病 预防计划（DPP）超重和肥胖的密集性多组分行为治疗 太昂贵，朴素且难以扩展，以至于可以向2/3人口提供它 那需要减肥。为了应对这一挑战，我们努力优化较少的燃烧 可以最大程度地减轻肥胖症的人群体重减轻的方法 支出。在智能减肥管理试验中，我们随机分配了400名成年人 超重/肥胖至阶梯式护理减肥干预措施，其中第一行治疗要么是1） 单独使用智能手机应用程序（应用程序）或2）应用程序加上教练（APP + C）。没有足够的参与者 减肥（即平均> 0.5磅/周的平均）被归类为无反应者，并重新融合以逐步加速 通过适度或剧烈的治疗组件来提高。初步结果表明：1）更多 患者的APP + C比APP实现了临床意义的6个月体重减轻； 2）APP + C非反应器 坚持剧烈的升级（短信和膳食更换）的人失去了与响应者一样多的体重 到12个月。这些引人入胜的发现表明需要测试更智能的踏入效率的效率 干预随机对照试验。智能试验是一项三臂，非效率的随机性 对照试验比较了针对金标准DPP和 控制。该试验将解决可扩展的阶梯护理干预措施是否可以达到金标准 通过以更少的成本实现可比的体重减轻来实现DPP。如果是这样，我们将以可扩展，有效的 干预措施使用阶梯护理模型来量身定制患者反应。除了评估临床非 - 自卑，全面的经济分析将为相对可用性和可扩展性提供信息。假设是 那是：1）较聪明的步进式护理将对金标准DPP不属于6个月的体重减轻； 2）更智能的干预将更具成本效益。我们将探索是否扩展 与DPP和对照相比，智能干预措施可在12个月时在12个月时进行减肥。 最后，我们将探索Smarter对体重减轻的影响的调解人和主持人，以告知未来 干预优化。如果成功，发现将支持传播具有成本效益的肥胖种群 管理策略促进使用所需的资源来治疗肥胖症 - 不超过更少。