ENRICH ALABAMA: Improving cardiovascular health of women and children through a novel home visiting intervention

项目摘要/摘要 女性心血管健康状况差(CVH)和心血管疾病(CVD)死亡率最高 在种族/少数民族中，低收入者，以及美国东南部妇女 心血管危险因素与不良妊娠结局的风险相关，并影响其子女的CVH。 有效和可扩展的干预措施可以改善或保留易受伤害的母亲和儿童的CVH 迫切需要，家访计划提供了一个独特而有效的平台，在这些期间进行干预 关键的生命周期。作为“促进母婴心血管健康的早期干预”的一部分 (丰富)“计划，本申请建议在阿拉巴马州(AL)建立丰富临床中心，该州有一些 全国最贫穷的脑血管病和最高的脑血管病死亡率。该项目建立并扩展了我们正在进行的 评估将肥胖预防干预纳入AL家访服务的工作。在协作中 与我们的家访计划合作伙伴和全国丰富财团，我们建议设计和 在家庭中实施一种促进母婴CVH的新型行为干预措施--Enrich-AL 参加了五个大型家访计划，在39个AL县提供服务。我们将进行类型1 混合有效性--实施试验(N=500-600个二元体，包括高危母亲及其0岁的孩子 4年)。在平均3年的随访中，这项试验将比较母亲和儿童的CVH指标 接受ENRICH-AL与标准的家访服务。在为这次试验做准备时，为期2年的UG3 规划阶段包括2个目标-UG3目标1：制定干预内容/交付和共同协议； 和UG3目标2：进行试点研究，以完善干预和共同方案，并培训家访 和研究人员在最后的协议中。在成功达到UG3里程碑之后，5年UH3 实施阶段将包括以下目标--UH3目标1：评估干预措施的有效性 根据妇女的CVH和儿童(初级)的标准BMI年龄(z分数)的综合测量 结果)；UH3目标2：评估对其他CVH危险因素、心理社会干预的有效性 结果和背景因素(次要结果)；UH3目标3：评估Enhile-AL的执行情况 由RE-AIM框架指导的结果；以及UH3的探索性目标：检查治疗主持人， 包括人口统计、健康的社会决定因素和与怀孕有关的因素。鉴于1)我们现有的 与家访计划的研究合作，2)进行CVH干预的专业知识，3) 参与其他大型、多地点合作项目，以及4)不成比例的心血管疾病负担 在AL方面经验丰富，我们处于独特的地位，能够为这一重要倡议做出贡献，以确定有效和 可扩展的解决方案，以改善妇女和儿童的CVH。

PROJECT SUMMARY / ABSTRACT Rates of poor cardiovascular health (CVH) and cardiovascular disease (CVD) mortality for women are greatest among racial/ethnic minorities, those with low-income, and residents of the southeastern U.S. Women’s cardiovascular risk factors relate to risk for adverse pregnancy outcomes and affect the CVH of their children. Effective and scalable interventions that improve or preserve CVH of vulnerable mothers and children are urgently needed, and home visiting programs provide a unique and efficient platform to intervene during these critical life periods. As part of the “Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)” program, this application proposes an ENRICH clinical center in Alabama (AL), a state with some of the nation’s poorest CVH and highest CVD mortality. This project builds upon and expands our ongoing work to evaluate an obesity prevention intervention integrated into home visiting services in AL. In collaboration with our home visiting program partners and the national ENRICH consortium, we propose to design and implement ENRICH-AL, a novel behavioral intervention promoting maternal and child CVH among families enrolled in five large home visiting programs that provide services in 39 AL counties. We will conduct a type 1 hybrid effectiveness-implementation trial (N=500-600 dyads, including high-risk mothers and their child aged 0- 4 years). During an average follow-up of 3 years, the trial will compare CVH indicators in mothers and children receiving ENRICH-AL versus standard home visiting services. In preparation for this trial, a 2-year UG3 planning phase includes 2 aims – UG3 Aim 1: Develop intervention content/delivery and a common protocol; and UG3 Aim 2: Conduct pilot studies to refine the intervention and common protocol, and train home visiting and research staff in the final protocol. Following successful attainment of UG3 milestones, the 5-year UH3 implementation phase will include the following aims – UH3 Aim 1: Evaluate effectiveness of the intervention based on a composite measure of CVH in women and standardized BMI-for-age (z-score) in children (primary outcomes); UH3 Aim 2: Evaluate effectiveness of the intervention for other CVH risk factors, psychosocial outcomes, and contextual factors (secondary outcomes); UH3 Aim 3: Evaluate ENRICH-AL implementation outcomes guided by the RE-AIM framework; and UH3 exploratory aim: Examine treatment moderators, including demographics, social determinants of health, and pregnancy-related factors. Given 1) our existing research collaborations with home visiting programs, 2) expertise in conducting CVH interventions, 3) participation in other large, multi-site collaborative projects, and 4) the disproportionate CVD burden experienced in AL, we are uniquely-positioned to contribute to this important initiative to identify effective and scalable solutions to improve CVH among women and children.