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.

超重和肥胖在美国已达到流行病的程度。由于很少有行为治疗对减肥有效，减肥手术是一个越来越重要的选择。虽然这些手术比心理治疗更有帮助，但术后体重减轻差异很大，一个值得注意的患者子集表现出次优的体重减轻或显著的体重恢复。坚持治疗建议可能是导致这些可变结局的原因。智能手机应用程序（应用程序）旨在增强行为改变或增强依从性，近年来呈指数级增长，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，需要高质量，足够有力的随机对照试验。这项快速通道研究（I/II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，以改善接受减肥手术的患者的依从性和行为/心理社会结局。具体而言，I期将利用一项小型术前随机试验（n=50），该试验针对肥胖症治疗候选人（Noom Coach for Bariatric Health）的教练主导的移动的应用程序，通过比较8周使用（n=25）与标准术前治疗（n =25）来确定该应用程序的初始疗效。该阶段将确定饮食、运动和心理健康变化的受试者内效应;估计低强度（无治疗）和高强度治疗（基于组的Noom Coach减肥健康）之间的受试者效应量;并验证Noom Coach参与者的局部和全局依从性算法。如果Noom肥胖健康教练在本研究阶段未为受试者带来益处，则将不会启动II期研究。第二阶段将在一项更大的测试（n=200）中比较常规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，以探索使用该应用程序是否是术后12个月后续术后体重轨迹的可行预测因素。我们假设 应用程序用户将更好地遵守饮食和体育活动建议， 手术后的心理社会适应此外，第二阶段将采用连续多次分配 随机试验（SMART）设计，以确定Noom Coach for Bariatric Health是否可以基于3-6个月的体重减轻来增加术后体重减轻。还将在第II阶段收集数据，以检查应用程序使用作为术后12个月内后续术后体重和心理社会轨迹的可行预测因素，并使用人体测量（体重减轻）、饮食和运动依从性以及心理社会调整来确定对手术干预的早期最佳反应的敏感性和特异性。如果Noom Coach对减肥健康的疗效得到证实，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整合到Noom Coach中的算法提供信息，并最大限度地提高医疗保健系统的价值。