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（55%为女性）。美国人口的显著老龄化产生了一项公共卫生任务，即确定有效的干预措施，以保持老年人，特别是妇女的健康和独立性。过去几十年的有力证据支持体育活动（PA）对预防老年人心血管（CV）和其他慢性疾病以及保持身体和认知健康的重要性。然而，尽管在老年人中增加PA的循证干预措施不断出现，这可能在人群水平上提供，但我们缺乏大规模随机试验数据显示这些干预措施可以预防临床CV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实用性试验，即妇女健康倡议坚强与健康（WHISH）试验。这项务实的试验将嵌入大型的、种族/民族多样化的WHI扩展队列中，该队列目前年龄为63-99岁，既新颖又节省资源。该试验将检验以下假设：旨在增加和/或维持PA至美国老年人推荐水平的集中公共卫生干预将减少重大CV事件（例如，心肌梗死（MI）、卒中和CVD死亡）。该研究还将通过检查总临床骨折、hi骨折、福尔斯和非CVD死亡率的风险来评价干预的安全性。初步筛选表明，50，500名WHI妇女将符合资格标准; PA干预组和“日常活动”对照组将分别包含约25，250名参与者（平均年龄约80岁）。我们将采用随机知情同意设计，观察性对照组和非知情同意者在WHI扩展研究中照常随访。WHISH干预措施建立在循证的、科学的行为方法和干预成分的基础上，这些方法和干预成分已被证明能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交互式语音应答（IVR）系统，这是一种增加老年人熟悉度的技术，旨在补充国家老龄化研究所（NIA）的Go 4Life（R）运动和体育活动材料。基于证据的IVR系统提供量身定制的建议，个性化的反馈和自我监控（记录活动）和个人目标设定的手段。在两个研究组中，将通过自我报告问卷和加速度测量子研究监测PA行为。基于WHI队列中观察到的发生率，我们预计80%的把握度可检测到随访期间主要CV事件的12.5%效应量。WHI的基础设施，结合创新的，以证据为基础的方法，在人口水平上提供PA干预，提供了一个独特的机会，以解决关键问题， “公共卫生PA干预能减少老年妇女的心血管疾病事件吗？“确定这个问题的答案，使用资源效率高，可扩展的干预措施， 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.