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.

项目总结 肥胖和心脏代谢并存是中老年人的主要慢性病。 在新冠肺炎大流行期间，不健康的生活习惯似乎在那些患有 多种慢性病，促进体重增加，并进一步扩大健康差距。中老年 患有潜在多发病的成年人，特别是少数民族，特别容易患上继发性肺炎。 大流行对健康的影响，是这项研究的目标人群。这项研究利用了我们的 糖尿病有效预防方案(DPP)及以DPP为基础的数十年翻译研究 团体生活方式平衡(GLB)干预；我们在使用电子健康记录方面的丰富经验 (EHR)用于患者识别和监控；以及我们与多部门利益攸关方在数字领域的合作伙伴关系 健康和健康解决方案。这项多点临床试验采用两阶段序贯随机设计 EHR集成、验证基础(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)，这是一种成熟的行为疗法。讲英语/西班牙语的成年人(N=1029)； ≥50岁，体重指数≥27和≥1心脏代谢状况，将在基线时随机分配到 基本干预或等待名单控制。基础干预的响应者，根据≥定义，体重下降3%，在6 周，将继续基础干预；体重减轻3%或体重数据丢失的参与者(即， 无应答者)将被重新随机化，以继续单独进行基本干预或使用PST加强干预 通过视频会议进行指导。等待名单参与者在12周的控制期后将被重新随机分配到 接受基础或强化干预，但不基于早期减肥而量身定做。基地 干预将使用EHR集成交付自我指导的GLB视频，每周1个，为期12周， 紧随其后的是数字行为变化和激励信息。强化干预包括基础干预 干预+PST视频会议辅导。所有参与者都将收到平板电脑、无线称重器和 可穿戴式活动跟踪器，并将在基线随机化后跟踪52周。目标1是 展示对减肥、行为改变和患者报告的结果的干预效果。我们 假设：(1)在早期干预中，强化干预比基础干预更有效 基本干预无响应者(自适应)和等待名单组参与者(非自适应)： 52周；(2)适应性强化干预比基础干预更有效 12周时疗效优于等待名单对照组。目标2是确定临床上的预测因素 根据社会人口学、临床和行为数据，个别患者体重显著减轻(5%) 交战特征。拟议的干预措施将立即产生广泛的影响。 关于获取、覆盖、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 这是一种廉价、可扩展的干预措施，很可能被保险公司采用。