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

项目摘要/摘要 作为NHLBI丰富计划的一部分，这项研究将测试旨在实施的干预措施 改善孕期高危母亲和幼儿的心血管健康状况 第一次是在分娩后两年。符合联邦有效性证据标准的家访(HV)模型 将被用来将现有的HV计划与在 整群随机多中心试验。 我们的多学科团队开创了女性行为和生活方式干预的先河 先兆和怀孕，以及出生后第一年的婴儿，包括那些使用HV的婴儿 肥胖的一级预防。我们还拥有联系和整合社区的广泛研究经验- 以医疗系统电子病历(EMR)为基础的医疗保健计划。对于这项提议，我们将 与医疗服务不足的阿巴拉契亚北部的两家护士-家庭伙伴关系机构合作 贫困率和贫穷的CVH，包括肥胖率、心脏病和烟草的高比率的区域 使用。我们将招募UH3期多中心试验所需的3000名孕妇中的≥500人。 在UG3阶段，我们将与我们的社区合作伙伴和工作伙伴一起试验我们提出的干预措施 与其他浓缩场和NHLBI合作开发UH3阶段通用方案。我们的建议 干预结合了社会认知理论的原则和理解贫困的框架 使用包括角色建模、目标设定和技能练习机会在内的技能建设课程 回家。五大干预支柱(生活方式行为、自我调节、负责任的父母教育、家庭 环境、EMR集成)旨在提高母亲的知识和自我效能，使其能够 建立健康的生活习惯和母亲养育方式，以改善CVH。与混合架构保持一致 试验类型1，研究设计旨在了解实施干预的背景。复合体 母亲们的主要结果将是美国心脏协会简单生活的修改版本 分娩后一年；结果也将在产后两年进行评估。童年的主要结果将是 由7个早期生命危险因素组成，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 将探索结果。此外，还将评估执行的背景和影响因素 将确定干预效果，以确定在HV中什么效果最好，对谁，在哪些情况下，为什么 以及如何。最后，我们的目标是领导网络努力，将HV摘要链接并集成到EMR中，以支持数据 与医疗保健提供者共享以增强干预效果，以便UH3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。

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.