Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older (PIVOT)

五十岁及以上成年人 EHR 综合生活方式干预项目 (PIVOT)

• 批准号: 10414413
• 负责人: Thomas George Kannampallil
• 金额: $ 71.6万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-15 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10414413
• 关键词: Accelerometer; Adopted; Adult; Age; Aging; Behavior; Behavior Therapy; Behavioral; Body Weight Changes; Body Weight decreased; Body mass index; COVID-19 pandemic; COVID-19 pandemic effects; Characteristics; Chronic; Clinical; Control Groups; Data; Development; Effectiveness; Elderly; Electronic Health Record; Equilibrium; Frequencies; Future; Goals; Habits; Health; Health system; Improve Access; Incidence; Individual; Insurance Carriers; Intervention; Life Style; Machine Learning; Measures; Minority; Modeling; Monitor; Motivation; Multi-Institutional Clinical Trial; Obesity; Outcome; Overweight; Participant; Patient Outcomes Assessments; Patients; Personal Satisfaction; Physical activity; Prevalence; Problem Solving; Public Health; Quality of life; Randomized; Research; Secondary to; Self-Direction; Sequential Multiple Assignment Randomized Trial; Sleep; Surveys; System; Tablets; Target Populations; Techniques; Testing; Translational Research; Treatment Efficacy; Unhealthy Diet; United States National Institutes of Health; Waiting Lists; Weight; Weight Gain; Work; adaptive intervention; adult obesity; aged; aging population; base; behavior change; behavior measurement; behavioral health intervention; burden of illness; cardiometabolism; care delivery; clinical predictors; clinically significant; comorbidity; design; diabetes prevention program; digital; digital health; digital healthcare; effectiveness evaluation; electronic data; experience; health disparity; human old age (65+); individual patient; innovation; intervention effect; intervention participants; lifestyle intervention; middle age; multi-site trial; multiple chronic conditions; novel strategies; pandemic disease; patient health information; physical inactivity; point of care; predictive modeling; prevent; primary outcome; programs; psychosocial; recruit; remote health care; response; sociodemographics; success; therapy development; trial design; unhealthy lifestyle; wearable device; weight loss intervention; wireless

PROJECT SUMMARY Obesity and cardiometabolic comorbidities are leading chronic conditions among middle-aged and older adults. During the COVID-19 pandemic unhealthy lifestyle habits seem to worsen to a greater degree in those with multiple chronic conditions, promoting weight gain and further widening health disparities. Middle to older aged adults with underlying multimorbid conditions, especially minorities, are particularly vulnerable to the secondary health effects of the pandemic and are the target population for this study. This study capitalizes on our decades-long translational research on the efficacious Diabetes Prevention Program (DPP) and DPP-based Group Lifestyle Balance (GLB) interventions; our extensive experience in using electronic health records (EHR) for patient identification and monitoring; and our partnerships with multisector stakeholders in digital health and wellness solutions. This multisite clinical trial uses a 2-stage sequential randomization design to test the adaptive and nonadaptive augmentation of an EHR-integrated, validated base (GLB video) intervention using problem solving treatment (PST), a proven behavior therapy. English/Spanish speaking adults (N=1029), ≥50 years with a body mass index ≥27 and ≥1 cardiometabolic conditions, will be randomized at baseline to base intervention or waitlist control. Responders to the base intervention, defined by ≥3% weight loss at 6 weeks, will continue the base intervention; participants with <3% weight loss or missing weight data (i.e., nonresponders) will be re-randomized to continue the base intervention alone or augmented with PST coaching via videoconference. Waitlist participants will be re-randomized after a 12-week control period to receive the base or the augmented intervention, but without tailoring based on early weight loss. The base intervention will use EHR-integrated delivery of the self-directed GLB videos, 1 per week for 12 weeks, followed by digital behavior change and motivational messages. The augmented intervention includes base intervention + PST videoconference coaching. All participants will receive a tablet, wireless weight scale, and wearable activity tracker and will be followed for 52 weeks after baseline randomization. Aim 1 is to demonstrate intervention effects on weight loss, behavior change, and patient-reported outcomes. We hypothesize: (1) the augmented intervention will be more effective than the base intervention both among early nonresponders to the base intervention (adaptive) and among participants in the waitlist group (nonadaptive) at 52 weeks; (2) the adaptive augmented intervention will be more efficacious than the base intervention and more efficacious than the waitlist control group at 12 weeks. Aim 2 is to identify predictors of clinically significant (5%) weight loss for individual patients, using sociodemographic, clinical and behavioral engagement characteristics. The proposed interventions are poised to have immediate and widespread impact on access, reach, delivery, effectiveness, scalability and sustainability. This study, if successful, will point the way toward an inexpensive, scalable intervention that would likely be adopted by insurers.

项目概要 肥胖和心脏代谢合并症是中老年人的主要慢性疾病。 在 COVID-19 大流行期间，不健康的生活习惯似乎在患有以下疾病的人中更加恶化： 多种慢性病，促进体重增加并进一步扩大健康差距。中老年 患有潜在多病性疾病的成年人，尤其是少数族裔，特别容易受到继发性疾病的影响 大流行对健康的影响，是本研究的目标人群。这项研究利用了我们的 对有效的糖尿病预防计划 (DPP) 和基于 DPP 的转化研究长达数十年 团体生活方式平衡（GLB）干预；我们在使用电子健康记录方面拥有丰富的经验 (EHR) 用于患者识别和监测；以及我们与数字领域多部门利益相关者的合作伙伴关系 健康和保健解决方案。这项多中心临床试验采用两阶段序贯随机化设计来测试 EHR 集成、经过验证的基础（GLB 视频）干预的自适应和非自适应增强 使用问题解决疗法（PST），这是一种行之有效的行为疗法。讲英语/西班牙语的成年人 (N=1029)， ≥50 岁且体重指数≥27 且患有≥1 心脏代谢疾病的患者，将在基线时被随机分配到 基地干预或候补名单控制。对基础干预有反应的人，定义为 6 岁时体重减轻 ≥3% 周内，将继续基础干预；体重减轻 <3% 或缺失体重数据的参与者（即 无反应者）将被重新随机化以继续单独进行基础干预或通过 PST 进行增强 通过视频会议进行辅导。候补名单参与者将在 12 周的控制期后重新随机分配，以 接受基础或增强干预，但不根据早期减肥进行调整。基地 干预将使用 EHR 集成方式传送自我导向的 GLB 视频，每周 1 次，持续 12 周， 其次是数字行为改变和激励信息。增强干预包括基础干预 干预+PST视频会议辅导。所有参与者都将收到平板电脑、无线体重秤以及 可穿戴活动追踪器，将在基线随机化后跟踪 52 周。目标 1 是 展示干预对体重减轻、行为改变和患者报告结果的影响。我们 假设：（1）增强干预比基础干预更有效 对基本干预（适应性）无反应的人和候补名单组（非适应性）的参与者中 52周； (2) 适应性增强干预比基础干预更有效 12 周时比等待名单对照组更有效。目标 2 是确定临床预测因素 根据社会人口统计学、临床和行为特征，个体患者体重显着减轻（5%） 参与特征。拟议的干预措施将产生直接和广泛的影响 关于访问、覆盖范围、交付、有效性、可扩展性和可持续性。这项研究如果成功，将指出 一种廉价、可扩展的干预措施，可能会被保险公司采用。