2-Generation Interventions to Improve Cardiovascular Health in Indiana and Illinois Through Home Visiting (2-NOURISH)

项目摘要 该申请提出了印第安纳州改善血管健康的两代干预措施， 伊利诺伊州通过家访（2-NOURISH）是为了响应RFA“早期干预，以促进 母亲和儿童心血管健康（ENRICH）多中心临床中心（RFA-HL-22-007）"。给定 孕产妇发病率和死亡率不断上升，采取干预措施，优化孕产妇心血管健康 (CVH)是迫切需要的。母亲CVH差也与子女CVH差相关。结果导致 围产期是进行干预的适当时机，但循证干预措施有限。家访 (HV)计划作为一个理想的设置进行干预研究，旨在改善孕产妇和 儿童CVH，因为他们已经为美国各地的高危人群提供服务， CVH。拟议的临床中心，2-NOURISH，由西北大学领导，与两个循证医学中心合作， HV模型（美国健康家庭[HFA]和父母作为教师[PAT]），以及基于证据的虚拟 生活方式干预的平台，国际慧俪轻体（WW），是唯一有资格参与所有 加强网络的各个方面，并大大提高网络的目标。在我们的应用程序中，我们 展示关键的先前经验，其中包括：（1）与HV模型的长期合作，包括 MPI Tandon的循证围产期抑郁症和压力管理干预（母亲和 婴儿）;（2）在母婴CVH的发展和评估方面具有重要的专业知识，特别是 在围产期;和（3）丰富的经验，招聘和保留不同的人口 进行行为干预。在UG 3阶段（第1-2年），我们将在ENRICH 网络，以制定一个共同的研究协议，调整干预内容，并进行试点测试。期间 在UH 3阶段（3-7年级），我们将与40个HV项目合作招募600名母子配对， 伊利诺伊州和印第安纳州在拟定的研究时间轴内，以实现ENRICH网络3000人的目标 二元组来检查准备实施、以CVH为重点、基于证据的干预措施的有效性。 我们仔细考虑了潜在的研究设计，并提出了一个混合的容错性，实现类型1 一项随机分组设计的试验，将在家庭访视水平上进行随机分组。此外，鉴于 潜在的母亲和后代的好处，在怀孕期间的干预，我们建议产前招聘。 我们提出的干预措施还包括创新的产前（促进压力管理技术， 家庭访客患者导航）和产后（利用虚拟交付平台进行强化生活方式干预， 同伴支持）组件。我们的临床中心还致力于发展早期阶段的技能 与临床试验设计相关的研究者和与CVH构建相关的家访者的技能， 组件和共同研究方案。2-NOURISH非常适合作为临床中心， 为该网络的长期使命做出贡献，以公平地改善孕产妇和幼儿CVH。

PROJECT SUMMARY This application proposing the 2-GeneratioN Interventions to ImprOve CardiovascUlaR Health in Indiana and IllinoiS Through Home Visiting (2-NOURISH) is in response to the RFA “Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite Clinical Center (RFA-HL-22-007)”. Given growing rates of maternal morbidity and mortality, interventions to optimize maternal cardiovascular health (CVH) are urgently needed. Poor maternal CVH is also associated with poor offspring CVH. As a result, the perinatal period is an opportune time to intervene, but evidence-based interventions are limited. Home visiting (HV) programs serve as an ideal setting to conduct intervention research aimed at improving maternal and child CVH as they already serve an at-risk population across the United States with a high prevalence of poor CVH. The proposed Clinical Center, 2-NOURISH, led by Northwestern, in partnership with two evidence-based HV models (Healthy Families America [HFA] and Parents as Teachers [PAT]), and an evidence-based virtual platform for lifestyle intervention, Weight Watchers International (WW), is uniquely qualified to participate in all aspects of the ENRICH Network and to substantially enhance the Network’s goals. In our application, we demonstrate key prior experiences, which include: (1) long-standing collaborations with HV models, including MPI Tandon’s evidence-based perinatal depression and stress management intervention (Mothers and Babies); (2) significant expertise in the development and assessment of maternal and child CVH, particularly during the perinatal period; and (3) extensive experience with recruitment and retention of diverse populations for behavior interventions. During the UG3 phase (Years 1-2), we will work collaboratively within the ENRICH Network to develop a common study protocol, adapt the intervention content, and conduct pilot tests. During the UH3 phase (Years 3-7), we will recruit 600 mother-child dyads in partnership with 40 HV programs in Illinois and Indiana within the proposed study timeline to achieve the ENRICH Network Goal of 3000 total dyads to examine the effectiveness of an implementation-ready, CVH-focused, evidence-based intervention. We carefully considered potential study designs and propose a Hybrid Effectiveness-Implementation Type 1 trial with a cluster randomized design that would randomize at the home visitor-level. Additionally, given the potential maternal and offspring benefits of intervention during pregnancy, we propose prenatal recruitment. Our proposed intervention also includes innovative prenatal (promotion of stress management techniques, home visitor patient navigation) and postpartum (intensive lifestyle intervention with a virtual delivery platform, peer support) components. Our Clinical Center is additionally committed to developing the skills of Early Stage Investigators related to clinical trial design and the skills of home visitors related to the construct of CVH, its components, and the common study protocol. 2-NOURISH is ideally suited to serve as a Clinical Center and contribute to the Network’s long-term mission to equitably improve maternal and early childhood CVH.