Early Intervention to Promote Cardiovascular Health of Mothers and Children in Northern Appalachia

项目总结/摘要 作为NHLBI的ENRICH计划的一部分，这项研究将测试一个实施准备干预设计 改善妊娠期高危母亲和幼儿的心血管健康（CVH）， 分娩后的头两年。符合联邦有效性证据标准的家访（HV）模式 将被用来比较现有的HV程序与那些在一个额外的CVH干预， 整群随机多中心试验。 我们的多学科团队率先为女性提供行为和生活方式干预， 孕前和妊娠以及出生后最初几年的婴儿，包括使用HV的婴儿， 肥胖的一级预防。我们也有广泛的研究经验，连接和整合社区- 基于健康系统电子病历（EMR）的医疗保健计划。对于这一建议，我们将 与北方阿巴拉契亚的两个护士家庭伙伴关系机构合作，这是一个医疗服务不足的地区。 贫困率高、CVH低的地区，包括肥胖、心脏病和烟草的高发病率 使用.我们将入组UH 3期多中心试验所需的3000例妊娠女性中的≥500例。 在UG 3阶段，我们将与我们的社区合作伙伴一起试验我们提出的干预措施， 与其他ENRICH研究中心和NHLBI合作开发UH 3阶段通用方案。我们提出的 干预结合了社会认知理论和理解贫困框架的原则 使用技能建设课程，其中包括角色建模，目标设定和技能实践机会， 回家五个干预支柱（生活方式行为，自我调节，响应式育儿，家庭 环境，EMR整合）旨在增加孕产妇知识和自我效能， 建立健康的生活习惯和母亲养育方式，以改善CVH。与Hybrid一致 试验类型1，研究设计旨在了解实施干预的背景。复合 对母亲的主要结果将是美国心脏协会的生活简单7个版本的修改版本 分娩后1年;产后2年也将评估结局。儿童期的主要结果将 是一个复杂的七个早期生活的风险因素，在2岁时进行最终评估。 对于这些结果，健康和心理社会指数的社会决定因素对 将探讨结果。此外，还将评估执行的背景， 将确定干预有效性，以确定HV中什么最有效，对谁有效，在什么情况下有效，为什么有效 以及如何做到。最后，我们的目标是引导网络努力将HV摘要链接并整合到EMR中，以允许数据 与医疗保健提供者共享，以提高干预有效性，以便UH 3方案可以评估 EMR与HV计划的整合是否改善了CVH综合指标以及健康公平性。

PROJECT SUMMARY/ABSTRACT As part of NHLBI’s ENRICH program, this research will test an implementation-ready intervention designed to improve cardiovascular health (CVH) among high risk mothers and young children during pregnancy and the first two years after delivery. Home visitation (HV) models meeting federal criteria of evidence of effectiveness will be leveraged to compare existing HV programs against those with an additional CVH intervention in a cluster-randomized, multicenter trial. Our multidisciplinary team has pioneered behavioral and lifestyle interventions for women during preconception and pregnancy and for infants during the first years after birth including those using HV for the primary prevention of obesity. We also have extensive research experience linking and integrating community- based healthcare programs with health system electronic medical records (EMRs). For this proposal, we will collaborate with two Nurse-Family Partnership agencies in Northern Appalachia, a medically underserved region with high rates of poverty and poor CVH, including high rates of obesity, heart disease, and tobacco use. We will enroll ≥500 of the 3000 pregnant women required for the UH3 phase multicenter trial. During the UG3 phase, we will pilot our proposed intervention with our community partners and work collaboratively with other ENRICH sites and NHLBI to develop the UH3 phase common protocol. Our proposed intervention incorporates tenets of Social Cognitive Theory and the Framework for Understanding Poverty using a skill-building curriculum that includes role modeling, goal-setting, and skill practice opportunities in the home. Five intervention pillars (Lifestyle Behaviors, Self-Regulation, Responsive Parenting, Home Environment, EMR Integration) are designed to increase maternal knowledge and self-efficacy in their ability to establish healthy lifestyle habits and maternal parenting practices to improve CVH. Consistent with a Hybrid Trial Type 1, the study design aims to understand the context for implementing the intervention. The composite primary outcome for mothers will be a modified version of the American Heart Association’s Life’s Simple 7 one year after childbirth; outcomes will also be assessed 2 years postpartum. The childhood primary outcome will be a composite of seven early life risk factors for poor CVH across with the final assessment at age 2 years. For these outcomes, the moderating effects of social determinants of health and psychosocial indices on outcomes will be explored. In addition, the context for implementation will be evaluated and factors influencing intervention efficacy will be identified to determine in HV, what works best, for whom, in which contexts, why and how. Lastly, we aim to lead network efforts to link and integrate HV summaries into EMRs to allow for data sharing with healthcare providers to enhance intervention effectiveness so that the UH3 protocol can evaluate whether EMR integration with HV programs improves CVH composite indicators as well as health equity.