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.

项目摘要 与国家老龄化研究所的研究重点一致，此R 01应用程序将调查 在≥ 2个Medicare定义的肥胖老年人中实现体重减轻的最佳干预序列 多种慢性疾病（MCC）。肥胖在老年人中日益普遍，特别是在那些 常见的慢性病如糖尿病、高血压或关节炎，增加了功能衰退的风险， 养老院安置和早期死亡率。减肥干预可以减轻这种不良后果; 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。临床医生 缺乏关于最有效的基于生活方式的干预措施的指导，以及如果第一种干预措施失败了，应该尝试哪种干预措施。 将进行一项创新的序贯、多重分配、随机化试验（SMART）设计，以确定 老年MCC患者体重减轻的最佳干预方法，为无应答者定制策略 到减肥。在为期52周的两阶段试验中，将招募180名患有肥胖和MCC的老年人， 比较两种减肥干预措施：一种以处方为重点的、医学上量身定制的减肥干预措施 （规定的），和行为为重点的，健康指导干预（行为）。与SMART一致 设计，在8周时，早期无应答者（体重减轻<2.5%）将被随机分配到：（a）更多的疗程， 原始任务;（B）处方和行为干预的组合;或（c）转换为 规定的、医学上量身定制的策略（初始的、一线的行为臂参与者）或以行为为重点的 健康教练提供策略（初始规定性武装参与者）。SMART将能够识别 在52周时最大限度地减轻体重的治疗组合。为此，该提案旨在：1）测试 使用早期适应性策略进行初始（一线）规定性或行为干预的优越性 无应答者; 2）评估初始体重减轻的模式，并比较无应答者的策略;以及3） 从社会角度审查维持拟议治疗的减肥成本效益 78周时的序列（干预完成后26周）。主要结果是体重减轻百分比， 52周;次要结局包括总体健康和身体功能、人体测量学、行为治疗 目标和危险因素以及临床指标。根据初步数据，假设老年人 肥胖和MCC将通过处方性的、医学上量身定制的干预实现更大的体重减轻， 估计适应性干预策略适合患者的特点将导致更好的结果比 固定干预。如果试验成功，将把适应性策略与固定的规定性策略或 在未来的比较有效性试验中的行为策略。拟议的方法应使患者受益 面临竞争和复杂的医疗问题，在临床试验中代表性不足。这项研究符合 美国国立卫生研究院的肥胖，营养研究和精确健康战略计划，并响应研究所 医学界呼吁进行远程医疗研究，这可能会通过推进健康服务科学来影响政策。