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

 描述(由申请人提供)：预计到2050年，65岁及以上的美国人数量将翻一番，达到8850万人(55%为女性)。美国人口的严重老龄化产生了一项公共卫生任务，即确定有效的干预措施，以保护老年人，特别是妇女的健康和独立。在过去的几十年里，令人信服的证据支持了体力活动(PA)对于预防心血管(CV)和其他慢性疾病以及保护老年人的身体和认知健康的重要性。然而，尽管增加老年人PA的循证干预措施稳步出现，这可能会在人群水平上实施，但我们缺乏大规模随机试验数据，表明这些干预措施可以预防临床心血管事件或影响公众健康。为了解决这一关键差距，我们建议进行一项大规模的随机对照务实试验，即妇女健康倡议强与健康(WHISH)试验。这项务实的试验将嵌入到目前年龄在63-99岁的、种族/民族多样化的WHI扩展队列中，这既新颖又节省资源。这项试验将检验这样一种假设，即旨在增加和/或保持老年美国成年人推荐的PA水平的集中式公共卫生干预将在~4年的随访中减少老年女性的主要心血管事件(例如，心肌梗死(MI)、中风和心血管死亡)。这项研究还将通过检查临床总骨折、骨折、跌倒和非心血管死亡的风险来评估干预的安全性。初步筛查表明，50,500名WHI妇女将符合资格标准；PA干预和“平时活动”对照组的EAC将有约25,250名参与者(平均年龄约80岁)。我们将使用随机同意设计，观察性对照组和非同意组在WHI扩展研究中照常进行跟踪。Whish干预建立在循证的、最先进的行为方法和干预成分的基础上，事实证明，这些方法和干预成分在增加老年妇女的PA方面是有效的，并采用创新的适应性战略来定制干预。我们将使用算法驱动的交互式语音应答(IVR)系统，这是一项为老年人增加熟悉度的技术，旨在补充国家老龄研究所(NIA)Go4Life(R)锻炼和体力活动材料。基于证据的IVR系统提供量身定制的建议、个性化的反馈以及自我监控(记录活动)和个人目标设定的手段。在两个研究组中，PA的行为将通过自我报告的问卷和加速度子研究进行监测。根据WHI队列中观察到的比率，我们预计80%的力量可以检测到在后续时间内主要心血管事件的12.5%的影响大小。世界卫生倡议的基础设施与创新的、基于证据的方法相结合，在人口层面上提供了一个解决关键问题的独特机会， “公共卫生协会的干预能减少老年女性的心血管事件吗？”确定这个问题的答案，使用一种资源高效、可扩展的干预措施，对公共卫生具有重大意义 意义。

 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.