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

项目概要/摘要 作为 NHLBI ENRICH 计划的一部分，这项研究将测试旨在实施的干预措施 改善妊娠期间高危母亲和幼儿的心血管健康（CVH） 分娩后的头两年。家访 (HV) 模型符合联邦有效性证据标准 将用于将现有的 HV 计划与具有额外 CVH 干预措施的计划进行比较 整群随机、多中心试验。 我们的多学科团队率先对女性进行行为和生活方式干预 孕前和怀孕以及出生后头几年的婴儿，包括使用 HV 的婴儿 肥胖的一级预防。我们还拥有链接和整合社区的丰富研究经验- 基于卫生系统电子病历 (EMR) 的医疗保健计划。对于这个提案，我们将 与医疗服务不足的北阿巴拉契亚地区的两个护士家庭合作机构合作 贫困率高、CVH 差的地区，包括肥胖、心脏病和烟草发病率高的地区 使用。我们将招募UH3期多中心试验所需的3000名孕妇中的≥500名。 在 UG3 阶段，我们将与社区合作伙伴一起试点我们提议的干预措施并开展工作 与其他 ENRICH 站点和 NHLBI 合作开发 UH3 相通用协议。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 使用技能培养课程，其中包括角色建模、目标设定和技能实践机会 家。五个干预支柱（生活方式行为、自我调节、响应式养育、家庭 环境、EMR 集成）旨在提高母亲的知识和自我效能感 建立健康的生活习惯和母亲育儿习惯，以改善 CVH。与混合动力一致 试验类型 1，研究设计旨在了解实施干预措施的背景。复合材料 母亲们的主要结局将是美国心脏协会的 Life's Simple 7 的修改版本 产后一年；产后 2 年还将评估结果。儿童时期的主要结局将 是 7 个生命早期 CVH 不良风险因素的综合结果，并在 2 岁时进行最终评估。 对于这些结果，健康的社会决定因素和心理社会指数对 将探讨结果。此外，还将评估实施背景和影响因素 将确定干预效果，以确定在 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。最后，我们的目标是领导网络工作，将高压摘要链接并集成到电子病历中，以允许数据 与医疗保健提供者共享以提高干预效果，以便 UH3 协议可以评估 EMR 与 HV 计划的整合是否可以改善 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.