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

项目总结/摘要 女性心血管健康状况不佳（CVH）和心血管疾病（CVD）死亡率最高 在种族/少数民族，低收入者和美国东南部居民中， 心血管危险因素与不良妊娠结局的风险有关，并影响其子女的CVH。 改善或保护弱势母亲和儿童CVH的有效和可扩展的干预措施是 迫切需要，家访计划提供了一个独特而有效的平台，在这些干预期间， 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， （ENRICH）”计划，该申请提出了在亚拉巴马（AL）的ENRICH临床中心，该州具有一些 全国最差的CVH和最高的CVD死亡率。该项目建立在我们正在进行的 工作，以评估肥胖预防干预纳入家访服务在AL。在合作 与我们的家访计划合作伙伴和国家ENRICH财团，我们建议设计和 实施ENRICH-AL，一种促进家庭中母婴CVH的新型行为干预 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1型 混合有效性-实施试验（N=500-600对，包括高危母亲及其0- 4年）。在平均3年的随访期间，该试验将比较母亲和儿童的CVH指标 接受ENRICH-AL与标准家访服务。为了准备这项试验，一个为期2年的UG 3 规划阶段包括2个目标-UG 3目标1：制定干预内容/交付和共同协议; 和UG 3目标2：开展试点研究，完善干预措施和共同协议，并培训家访 和研究人员的参与在成功实现UG 3里程碑之后， 实施阶段将包括以下目标：UH 3目标1：评估干预措施的有效性 基于女性CVH和儿童年龄标准化BMI（z评分）的复合测量（主要 UH 3目标2：评价其他CVH风险因素、心理社会因素 结果和背景因素（次要结果）; UH 3目标3：评价ENRICH-AL实施情况 RE-AIM框架指导的结果;和UH 3探索性目标：检查治疗调节剂， 包括人口统计学、健康的社会决定因素和怀孕相关因素。（1）现有 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CVD负担 在AL经验丰富，我们有能力为这一重要举措做出贡献，以确定有效的， 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.