Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children (ENRICH)

项目摘要 这项两阶段随机对照试验将检查其实施情况和效果。 对产后母亲和幼儿进行心血管健康(CVH)干预 直到3岁。我们将把CVH干预转变为基于证据的家访计划， 家庭体检(FCU)创建FCU-心脏。通过类型1混合效率- 实施设计，第一阶段RCT试点研究将测试可行性和有效性 FCU心脏(FCU心脏，n=100；FCU，n=50)(目标1a和1b)。混合动力车的第二个目标 研究是为了了解实施FCU-心脏的范围、参与度和背景 为多中心家访模式试验的开展收集资料。第二 我们研究的阶段将比较FCU-心脏和标准FCU的结果 协作性多中心随机试验(目标2和3)。我们的FCU-心脏计划旨在 改善高危母亲(低收入有心血管风险的母亲)的CVH 怀孕-高血压、糖尿病、肥胖)与传统的FCU和其他家庭进行比较 通过纳入针对以下目标的个性化、有文化能力的干预措施来访问项目 饮食和锻炼，血压控制，压力管理和自我护理，以及吸烟 停止。干预包括心血管评估和反馈，随后是 由家庭教练在3-4周的模块中提供量身定制的治疗计划，以建立目标 并跟踪进度。这些会议将努力取得积极的CVH结果，并 使婴儿的母亲能够通过教育和联系实现其目标 我们假设的资源也将保留子CVH。初步分析将评估 FCU心脏移植对1、2和3岁儿童母婴CVH结局的影响 与单独的FCU相比。此外，基于黑人中CVH并发症的较高发生率 妇女和儿童，我们将检查FCU-心脏与单独FCU对产妇和儿童的影响 1年、2年和3年评估(目标3)的儿童CVH种族差异。此应用程序具有 产后母亲和幼儿在分娩期间改善CVH轨迹的潜力 在其发展的关键时期，提供长期的健康益处。

Project Summary This two-phased randomized controlled trial will examine the implementation and effectiveness of a cardiovascular health (CVH) intervention on postpartum mothers and young children through age 3. We will adapt a CVH intervention into an evidence-based home visiting program, Family Check-Up (FCU) to create FCU-Heart. Through a Type 1 hybrid effectiveness- implementation design, the first phase RCT pilot study will test the feasibility and effectiveness of FCU-Heart (FCU-Heart, n=100; FCU, n=50) (Aim 1a and 1b). A second goal of the hybrid study is to understand the reach, engagement, and context for implementation of FCU-Heart and gather information for development of the multi-center home visiting model trial. The second phase of our study will compare the FCU-Heart to standard FCU outcomes through a collaborative, multicenter randomized trial (Aims 2 and 3). Our FCU-Heart program is intended to improve the CVH of high-risk mothers (low-income with cardiovascular risk during pregnancy—hypertension, diabetes, obesity) compared to the traditional FCU and other home visiting programs by incorporating individualized, culturally competent interventions that target diet and exercise, blood pressure control, stress management and self-care, and smoking cessation. The intervention includes cardiovascular assessment and feedback, followed by a tailored treatment program delivered by family coaches in 3-4 week modules to establish goals and track progress. These sessions will work towards obtaining positive CVH outcomes and empowering mothers of infants to achieve their goals through education and a connection to resources which we hypothesize will also preserve child CVH. Primary analyses will assess the impact of FCU-Heart on maternal and child CVH outcomes at child ages 1, 2, and 3 years compared to FCU Alone. Further, based on the higher rates of CVH complications among Black women and children, we will examine the effects of FCU-Heart vs FCU alone on maternal and child CVH racial disparities at the 1-, 2-, and 3-year assessments (Aim 3). This application has the potential to improve the CVH trajectories of postpartum mothers and young children during a critical period of their development, providing long-lasting health benefits.