Noom Coach for Bariatric Surgery

Noom 减肥手术教练

• 批准号: 9464753
• 负责人: THOMAS B HILDEBRANDT
• 金额: $ 22.5万
• 依托单位: NOOM, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-14 至 2018-09-13
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9464753
• 关键词: Adherence; Algorithms; American; Anxiety; Bariatrics; Behavior; Behavior Therapy; Behavioral; Body Weight Changes; Body Weight decreased; Caring; Cellular Phone; Conflict (Psychology); Data; Diet; Dropout; Eating; Epidemic; Failure; Funding; Guidelines; Health; Healthcare Systems; Impaired health; Impairment; Individual; Intervention; Length; Medical; Mental Depression; Morbid Obesity; Obesity; Operative Surgical Procedures; Outcome; Overweight; Participant; Patient-Focused Outcomes; Patients; Persons; Phase; Physical activity; Postoperative Period; Preoperative Care; Procedures; Psychosocial Factor; Randomized; Randomized Controlled Trials; Recommendation; Reporting; Research; Sampling; Sensitivity and Specificity; System; Technology; Testing; Time; Training; United States; Weight; bariatric surgery; base; behavior change; behavioral outcome; cost; design; diet and exercise; efficacy testing; exercise adherence; experience; health related quality of life; improved; improved outcome; lifestyle intervention; mobile application; mobile computing; novel; patient subsets; prediction algorithm; predictive modeling; programs; psychosocial; psychosocial adjustment; randomized trial; response; standard care; treatment as usual; treatment group; trial design

Overweight and obesity have reached epidemic proportions in the United States. As few behavioral treatments are effective for weight loss, bariatric surgery is an increasingly important option. Although these procedures are more helpful than psychosocial treatments, post-operative weight losses vary widely and a notable subset of patients demonstrate suboptimal weight loss or substantial weight regain. Adherence to treatment recommendations is a likely contributor to these variable outcomes. Smartphone applications (apps) designed to augment behavior change or enhance adherence, have expanded exponentially in recent years, and are a potentially useful option to improve outcomes, but rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. This Fast Track study (Phase I/II) application will test a combined smartphone app and health coaching system to improve adherence, and behavioral/psychosocial outcomes for patients receiving bariatric surgery. Specifically, Phase I will utilize a small pre-surgery randomized trial (n=50) of a coach-led mobile application for bariatric candidates (Noom Coach for Bariatric Health), to establish the initial efficacy of this app by comparing the use of 8 weeks of use (n=25) to standard pre-surgery treatment (n=25). This phase will establish within-subject effects for change in diet, exercise, and psychosocial health; estimate between subject effect sizes between low intensity (no treatment) and high intensity treatment (group-based Noom Coach Bariatric Health); and validate local and global adherence algorithms for Noom Coach participants. If Noom Coach for Bariatric Health does not produce benefits for participants in this phase of the study, Phase II will not be initiated. Phase II would compare usual pre-operative care and pre-surgical use of Noom Coach for Bariatric Health on post-surgery adherence and psychosocial variables in a larger test (n=200) to explore whether usage of the app is a viable predictor of subsequent post-operative weight trajectories 12 months following surgery. We hypothesize that app users will demonstrate greater adherence to diet and physical activity recommendations and better psychosocial adjustment following surgery. In addition, Phase II will use a sequential multiple assignment randomized trial (SMART) design to determine whether Noom Coach for Bariatric Health can augment weight loss post-surgery based on weight loss from 3-6 months. Data will also be collected in Phase II to examine app usage as a viable predictor of subsequent post-operative weight and psychosocial trajectories in the 12 months post-surgery and establish sensitivity and specificity of early optimal response to surgical intervention using anthropometric (weight loss), diet and exercise adherence, and psychosocial adjustment. If the efficacy of Noom Coach for Bariatric Health is demonstrated, critical information will be available for developing a Phase III sequential multi-phase adaptive trial aimed at informing algorithms for integration into Noom Coach more broadly, and maximizing value within health care systems.

在美国，超重和肥胖已达到流行病的程度。由于很少有行为疗法对减肥有效，减肥手术成为越来越重要的选择。尽管这些手术比社会心理治疗更有帮助，但术后体重减轻差异很大，并且值得注意的一部分患者表现出体重减轻不理想或体重大幅反弹。遵守治疗建议可能是导致这些可变结果的一个因素。旨在增强行为改变或增强依从性的智能手机应用程序 (app) 近年来呈指数级增长，并且是改善结果的潜在有用选择，但对应用程序的严格研究有限，高质量、动力充足的随机对照试验需要大样本。这项快速通道研究（第一/二期）应用程序将测试智能手机应用程序和健康指导系统的组合，以提高接受减肥手术的患者的依从性和行为/心理社会结果。具体来说，第一阶段将利用教练主导的减肥候选人移动应用程序（Noom Coach for Bariatric Health）进行小型术前随机试验（n = 50），通过比较 8 个应用程序的使用情况来确定该应用程序的初步功效。使用周数（n=25）到标准术前治疗（n=25）。这一阶段将确定饮食、运动和社会心理健康改变的受试者内部影响；估计低强度（无治疗）和高强度治疗（基于小组的 Noom Coach Bariatric Health）之间的受试者效应大小；并验证 Noom Coach 参与者的本地和全局遵守算法。如果 Noom Coach for Bariatric Health 没有为该阶段研究的参与者带来好处，则不会启动第二阶段。第二阶段将在更大的测试（n = 200）中比较通常的术前护理和术前使用 Noom Coach for Bariatric Health 对术后依从性和心理社会变量的影响，以探讨该应用程序的使用是否是后续手术的可行预测因素术后 12 个月的体重轨迹。我们假设 应用程序用户将表现出更好地遵守饮食和身体活动建议，并且更好 手术后的心理社会调整。此外，第二阶段将使用顺序多重分配 随机试验 (SMART) 设计旨在根据 3-6 个月的体重减轻情况来确定 Noom Coach for Bariatric Health 是否可以增强手术后的减肥效果。第二阶段还将收集数据，以检查应用程序的使用情况，作为术后 12 个月内术后体重和心理社会轨迹的可行预测指标，并利用人体测量（体重减轻）确定手术干预的早期最佳反应的敏感性和特异性、饮食和运动的坚持以及心理社会的调整。如果 Noom Coach 对减肥健康的功效得到证实，将为开发 III 期连续多阶段适应性试验提供关键信息，该试验旨在为更广泛地集成到 Noom Coach 中的算法提供信息，并在医疗保健系统中实现价值最大化。