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 与国家老化研究所的研究重点一致，该R01申请将调查 最佳干预序列以实现肥胖症老年人的体重减轻和≥2个Medicare定义 多个慢性病（MCC）。老年人肥胖症的越来越普遍，特别是 常见的慢性疾病，例如糖尿病，高血压或关节炎，会增加功能下降的风险， 护士家庭安置和早期死亡率。减肥干预措施可以减轻这种不良后果； 但是，由于患者的临床异质性，通常观察到对治疗的反应差异。临床医生 缺乏有关最有效的基于生活方式的干预措施的指导，如果第一个措施失败，则缺乏尝试进行的干预措施。 将进行创新的顺序，多次任务，随机试验（智能）设计，以识别 老年人使用MCC体重减轻的最佳干预方法，非反应者的裁缝策略 减肥。在为期52周，两阶段试验期间 比较两种减肥干预措施：一种规定的专注，医学量身定制的，减肥干预措施 （规定），以及以行为为重点的健康教练干预（行为）。与智能一致 设计，在8周内，早期的非反应者（减肥<2.5％）将随机分配到：（a）更多的会话 原始作业； （b）规定性和行为干预的结合；或（c）开关 规定性，医学量身定制的策略（初始，一线行为部门参与者）或以行为为重点 健康教练策略（最初的规定臂参与者）。智能将使身份证明 在52周时减轻体重减轻的治疗组合。为此，该提案的目的是：1）测试 使用自适应策略的初始（一线）规定或行为干预的优势 非响应者； 2）评估初始体重减轻的模式，并比较非反应者的策略； 3） 从社会角度检查成本效益，以维持拟议治疗的体重减轻 78周的序列（干预后完成26周）。主要结果是减肥百分比。 52周；次要结果包括全球健康和身体机能，人体测量法，行为治疗 目标和风险因素以及临床指数。根据初步数据，假设 肥胖和MCC将通过处方，医学量身定制的干预措施实现更大的体重减轻，并且 量身定制的针对患者特征的估计适应性干预策略将带来更好的结果 固定干预。如果试验成功，则将自适应策略与固定的规定或 在未来的比较有效性试验中的行为策略。拟议的方法应受益于患者 面临临床试验中人数不足的竞争且复杂的医疗问题。这项研究与 NIH肥胖，营养研究和精确健康的战略计划，对研究所有反应 医学对远程医疗研究的呼吁，该研究可能通过推进卫生传递科学来影响政策。