Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults with Multiple Chronic Conditions: A Sequential, Multiple Assignment, Randomized Trial

优化对患有多种慢性病的老年人进行远程医疗的减肥干预：一项序贯、多项分配、随机试验

• 批准号: 10583917
• 负责人: John A. Batsis
• 金额: $ 77.39万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-15 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10583917
• 关键词: Address; Anthropometry; Arthritis; Behavior Therapy; Behavioral; Body Weight Changes; Body Weight decreased; Cessation of life; Characteristics; Chronic; Clinical; Clinical Trials; Collaborations; Combined Modality Therapy; Complex; Cost Analysis; Data; Diabetes Mellitus; Dietitian; Elderly; Enrollment; Evaluation; Evidence based intervention; Future; Geriatrics; Goals; Health; Health Care Costs; Health Promotion; Health behavior change; Hypertension; Individual; Institute of Medicine (U.S.); Intervention; Licensing; Life Style; Medical; Medicare; Modeling; Motivation; National Institute on Aging; Nursing Homes; Nutritional Study; Obesity; Outcome; Participant; Patients; Pattern; Persons; Physical Function; Pilot Projects; Policies; Positioning Attribute; Precision Health; Prevalence; Problem Solving; Quality of life; Quality-Adjusted Life Years; Randomized; Research; Research Priority; Risk; Risk Factors; Science; Sequential Multiple Assignment Randomized Trial; Strategic Planning; Telemedicine; Testing; Time; Training; United States National Institutes of Health; Weight; Weight Gain; Work; adaptive intervention; adult obesity; adverse outcome; arm; clinical decision-making; clinical heterogeneity; clinically significant; comparative effectiveness trial; cost effective intervention; cost effectiveness; diet and exercise; disability; disability risk; efficacy evaluation; exercise prescription; functional decline; global health; health training; high risk; high risk population; improved; incremental cost; indexing; individualized medicine; innovation; mortality; multiple chronic conditions; muscle form; personalized approach; personalized care; physical therapist; pilot test; post intervention; precision medicine; primary care provider; primary outcome; randomized trial; remote monitoring; response; secondary outcome; skills; success; telehealth; treatment response; treatment strategy; trial design; weight loss intervention

PROJECT SUMMARY Consistent with the research priorities of the National Institute on Aging, this R01 application will investigate the optimal intervention sequence to achieve weight loss in older adults with obesity and ≥ 2 Medicare-defined multiple chronic conditions (MCC). The growing prevalence of obesity in older adults, particularly in those with common chronic conditions such as diabetes, hypertension, or arthritis, increases the risk of functional decline, nursing home placement, and early mortality. Weight loss interventions can mitigate such adverse outcomes; however, differential response to treatment is often observed due to a patient’s clinical heterogeneity. Clinicians lack guidance on the most effective lifestyle-based intervention, and which intervention to try if the first one fails. An innovative Sequential, Multiple Assignment, Randomized Trial (SMART) design will be conducted to identify optimal intervention approaches for weight loss in older adults with MCC, tailoring strategies for non-responders to weight loss. During the 52-week, two-stage trial, 180 older adults with obesity and MCC will be enrolled to compare two weight loss interventions: a prescriptively focused, medically tailored, weight loss intervention (prescriptive), and a behaviorally focused, health coaching intervention (behavioral). Consistent with a SMART design, at 8-weeks, early non-responders (weight loss of <2.5%) will be randomized to: (a) more sessions of the original assignment; (b) a combination of prescriptive and behavioral interventions; or (c) a switch to a prescriptive, medically tailored strategy (initial, first-line behavioral arm participants) or to a behaviorally focused health coach-delivered strategy (initial prescriptive arm participants). The SMART will enable the identification of the treatment combinations that maximize weight loss at 52-weeks. To this end, the proposal aims to: 1) test the superiority of an initial (first-line) prescriptive or behavioral intervention using an adaptive strategy for early non-responders; 2) assess the patterns of initial weight loss and compare strategies for non-responders; and 3) examine the cost-effectiveness from a societal perspective for maintaining weight loss of the proposed treatment sequences at 78-weeks (26-weeks post-intervention completion). The primary outcome is percent weight loss at 52-weeks; secondary outcomes include global health and physical function, anthropometry, behavioral treatment targets and risk factors, and clinical indices. Based on preliminary data, it is hypothesized that older adults with obesity and MCC will achieve greater weight loss with a prescriptive, medically tailored intervention, and the estimated adaptive intervention strategy tailored to a patient’s characteristics will lead to better outcomes than a fixed intervention. If the trial is successful, the adaptive strategy will be compared to a fixed prescriptive or behavioral strategy in a future comparative effectiveness trial. The proposed approach should benefit patients facing competing and complex medical issues who are underrepresented in clinical trials. This study aligns with the NIH Strategic Plans for Obesity, Nutrition Research, and Precision Health, and is responsive to the Institute of Medicine’s call for telehealth research that may influence policy by advancing health delivery science.

项目概要 与国家老龄化研究所的研究重点一致，该 R01 应用程序将调查 为肥胖且 ≥ 2 医疗保险定义的老年人实现减肥的最佳干预顺序 多种慢性病（MCC）在老年人中的患病率不断上升，尤其是患有肥胖症的老年人。 常见的慢性病，​​如糖尿病、高血压或关节炎，会增加功能衰退的风险， 疗养院安置和早期死亡率干预措施可以减轻此类不良后果； 然而，由于患者的临床异质性，经常观察到对治疗的不同反应。 缺乏关于最有效的基于生活方式的干预措施的指导，以及如果第一个干预措施失败应尝试哪种干预措施。 将进行创新的序贯、多重分配、随机试验 (SMART) 设计来确定 患有 MCC 的老年人减肥的最佳干预方法，针对无反应者制定策略 在为期 52 周的两阶段试验中，将招募 180 名患有肥胖症和 MCC 的老年人。 比较两种减肥干预措施：一种以规定为重点、根据医学量身定制的减肥干预措施 （规定性），以及以行为为重点的健康指导干预（行为），与 SMART 一致。 根据设计，在 8 周时，早期无反应者（体重减轻 <2.5%）将被随机分配至：(a) 更多疗程 原来的任务；(b) 规定性干预和行为干预的结合；或 (c) 转向 规定性的、医学定制的策略（初始的一线行为组参与者）或以行为为重点的策略 健康教练提供的策略（初始处方组参与者）将能够进行识别。 为此，该提案旨在： 1) 进行测试。 使用适应性策略进行早期（一线）规定性或行为干预的优越性 无反应者；2) 评估初始体重减轻模式并比较无反应者的策略； 从社会角度检查拟议治疗维持减肥的成本效益 78 周（干预完成后 26 周）时的序列主要结果是体重减轻百分比。 52周；次要结果包括整体健康和身体功能、人体测量、行为治疗 根据初步数据，老年人的目标和风险因素以及临床指标。 肥胖和MCC将通过规范的、医学定制的干预措施实现更大的减肥效果，并且 估计根据患者特征量身定制的适应性干预策略将比传统干预策略带来更好的结果 如果试验成功，适应性策略将与固定的规定或方法进行比较。 未来比较有效性试验中的行为策略应该使患者受益。 面临竞争和复杂的医疗问题，在临床试验中代表性不足。 NIH 肥胖、营养研究和精准健康战略计划，并对研究所做出回应 医学部呼吁进行远程医疗研究，这可能会通过推进医疗服务科学来影响政策。