Physical Activity to Improve CV Health in Women: A Pragmatic Trial CCC-Lead

体力活动改善女性心血管健康：一项务实试验 CCC-Lead

• 批准号: 9217661
• 负责人: Marcia L Stefanick
• 金额: $ 137.28万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-09 至 2020-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9217661
• 关键词: Accelerometer; Address; Adult; Aerobic; Age; Aging; Algorithms; American; Behavior; Behavioral Sciences; Body mass index; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chronic Disease; Clinical; Cognitive; Communities; Complement; Consent; Coronary; Data; Disease Outcome; Elderly; Eligibility Determination; Enrollment; Equilibrium; Ethnic Origin; Ethnic group; Event; Evidence based intervention; Exercise; Familiarity; Feedback; Fracture; Goals; Health; Hip Fractures; Hour; Human; Impairment; Individual; Intervention; Ischemic Stroke; Lead; Leisures; Link; Medical Records; Methods; Monitor; Multi-Institutional Clinical Trial; Myocardial Infarction; National Institute on Aging; Observational Study; Older Population; Outcome; Participant; Patient Self-Report; Peripheral arterial disease; Physical Exercise; Physical Function; Physical activity; Physicians; Population; Population Group; Public Health; Questionnaires; Race; Randomized; Randomized Controlled Trials; Records; Research Design; Research Infrastructure; Resources; Risk; Safety; Strenuous Exercise; Stroke; System; Technology; Testing; Time; United States; United States Centers for Medicare and Medicaid Services; Venous; Voice; Walking; Woman; Women' s Health; adjudication; aged; base; burden of illness; cardiovascular disorder risk; cardiovascular health; cardiovascular risk factor; cohort; comparison group; cost; design; disorder risk; effective intervention; evidence base; experience; falls; flexibility; follow-up; functional status; improved; indexing; innovation; mortality; novel; older women; pragmatic trial; prevent; programs; public health intervention; public health relevance; randomized trial; rapid growth; response; screening; secondary outcome; sedentary; sedentary lifestyle; strength training; therapy design

 DESCRIPTION (provided by applicant): The number of Americans aged 65 and older is projected to double to 88.5 million by 2050 (55% women). The significant aging of the U.S. population creates a public health mandate to identify effective interventions for preserving the health and independence of older people, especially women. Compelling evidence over the past several decades supports the importance of physical activity (PA) for preventing cardiovascular (CV) and other chronic diseases, and preserving physical and cognitive health, in older adults. Yet, despite the steady emergence of evidence-based interventions for increasing PA in older adults, which could potentially be delivered at a population level, we lack large-scale randomized trial data showing that these interventions can prevent clinical CV events or impact the public's health. To address this critical gap, we propose to conduct a large-scale, randomized controlled pragmatic trial, the Women's Health Initiative Strong & Healthy (WHISH) trial. This pragmatic trial will be embedded in the large, race/ethnicity diverse, WHI Extension cohort, now aged 63-99 years, which is both novel and resource-efficient. The trial will test the hypothesis that a centralized public health intervention designed to increase and/or maintain PA to levels recommended for older U.S. adults will reduce major CV events (e.g., myocardial infarction (MI), stroke, and CVD death) in older women over ~4 years of follow-up. The study will also evaluate the safety of the intervention by examining risks of total clinical fracture, hi fracture, falls, and non-CVD mortality. Preliminary screening indicates that 50,500 WHI women will meet eligibility criteria; the PA intervention and "usual activity" comparison groups will eac contain ~25,250 participants (mean age ~80 years). We will use a randomized consent design, with the observational comparison group and non-consenters followed as usual within the WHI Extension study. The WHISH intervention builds upon evidence-based, state-of-the-science behavioral approaches and intervention components that have proven to be effective in increasing PA in older women, with innovative adaptive strategies to tailor the intervention. We will use an algorithm-driven interactive voice response (IVR) system, a technology of increasing familiarity to older adults, built to complement National Institute on Aging (NIA) Go4Life(R) Exercise & Physical Activity materials. The evidence-based IVR system provides tailored advice, with personalized feedback and a means for self-monitoring (logging activity) and personal goal setting. PA behavior will be monitored by self-reported questionnaire and an accelerometry substudy in both study groups. Based on observed rates in the WHI cohort, we project 80% power to detect a 12.5% effect size for major CV events over the follow-up period. The WHI infrastructure, combined with innovative, evidence-based methods to deliver the PA intervention at a population level, provides a unique opportunity to address the critical question, "Can a public health PA intervention reduce CVD events in older women?" Determining the answer to this question, using a resource-efficient, scalable intervention, has major public health significance.

 描述（由适用提供）：到2050年，65岁及65岁及65岁以上的美国人人数将翻倍至8850万（55％的女性）。美国人口的重大老龄化创造了公共卫生的任务，以确定有效的干预措施，以维护老年人，尤其是妇女的健康和独立性。在过去的几十年中，令人信服的证据支持了体育锻炼（PA）对于预防心血管（CV）和其他慢性疾病的重要性，并保留老年人的身体和认知健康。然而，努力在老年人中进行大规模，随机控制的PA，这可能会在人群水平上进行，我们缺乏大规模的随机试验数据，表明这些干预措施可以防止临床简历事件或影响公众的健康。为了解决这个关键的差距，我们建议进行一项大规模，随机对照的务实试验，即《妇女健康计划》强大健康（WHISH）试验。这项务实的试验将嵌入到现年63 - 99岁的大型种族/种族潜水员中，既新颖又有资源效率。该试验将检验以下假设：旨在将PA提高和/或将PA提高到建议的年长的成年人建议的集中式公共卫生干预措施将减少在约4年的随访期间，老年妇女中的老年妇女的重大简历事件（例如，心肌梗塞（MI），中风和CVD死亡）。该研究还将通过检查总临床骨折，骨折，跌倒和非CVD死亡率的风险来评估干预措施的安全性。初步筛查表明，有50,500名妇女将符合资格标准； PA干预和“通常的活动”比较组将尽早包含约25,250名参与者（平均年龄）约80岁）。我们将使用随机同意设计，在WHI扩展研究中按照观察性比较组和非符合者遵循。 Whish干预措施基于证据，最先进的行为方法和干预组件，这些方法已被证明可以有效地增加老年妇女的PA，并采用创新的适应性策略来定制干预措施。我们将使用算法驱动的互动语音响应（IVR）系统，这是一种越来越多的老年人熟悉的技术，该技术是为了补充国家老化研究所（NIA）GO4LIFE（R）运动和体育锻炼材料。基于证据的IVR系统提供了量身定制的建议，具有个性化的反馈以及一种自我监控（记录活动）和个人目标设定的手段。 PA行为将通过自我报告的问卷调查和两个研究组的加速度测定法监测。根据在WHI队列中观察到的速率，我们投射了80％的功率，以检测到随访期间主要CV事件的效应大小为12.5％。 WHI基础设施以及在人群层面提供PA干预的创新，基于证据的方法，为解决关键问题提供了独特的机会， “公共卫生PA干预可以减少老年妇女的CVD事件吗？”使用资源效率高，可扩展的干预确定这个问题的答案，具有主要的公共卫生 意义。