ENRICH ALABAMA: Improving cardiovascular health of women and children through a novel home visiting intervention - PROJECT SUMMARY / ABSTRACT Rates of poor cardiovascular health (CVH) and cardiovascular disease (CVD) mortality for women are greatest among racial/ethnic minorities, those with low-income, and residents of the southeastern U.S. Women’s cardiovascular risk factors relate to risk for adverse pregnancy outcomes and affect the CVH of their children. Effective and scalable interventions that improve or preserve CVH of vulnerable mothers and children are urgently needed, and home visiting programs provide a unique and efficient platform to intervene during these critical life periods. As part of the “Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)” program, this application proposes an ENRICH clinical center in Alabama (AL), a state with some of the nation’s poorest CVH and highest CVD mortality. This project builds upon and expands our ongoing work to evaluate an obesity prevention intervention integrated into home visiting services in AL. In collaboration with our home visiting program partners and the national ENRICH consortium, we propose to design and implement ENRICH-AL, a novel behavioral intervention promoting maternal and child CVH among families enrolled in five large home visiting programs that provide services in 39 AL counties. We will conduct a type 1 hybrid effectiveness-implementation trial (N=500-600 dyads, including high-risk mothers and their child aged 0- 4 years). During an average follow-up of 3 years, the trial will compare CVH indicators in mothers and children receiving ENRICH-AL versus standard home visiting services. In preparation for this trial, a 2-year UG3 planning phase includes 2 aims – UG3 Aim 1: Develop intervention content/delivery and a common protocol; and UG3 Aim 2: Conduct pilot studies to refine the intervention and common protocol, and train home visiting and research staff in the final protocol. Following successful attainment of UG3 milestones, the 5-year UH3 implementation phase will include the following aims – UH3 Aim 1: Evaluate effectiveness of the intervention based on a composite measure of CVH in women and standardized BMI-for-age (z-score) in children (primary outcomes); UH3 Aim 2: Evaluate effectiveness of the intervention for other CVH risk factors, psychosocial outcomes, and contextual factors (secondary outcomes); UH3 Aim 3: Evaluate ENRICH-AL implementation outcomes guided by the RE-AIM framework; and UH3 exploratory aim: Examine treatment moderators, including demographics, social determinants of health, and pregnancy-related factors. Given 1) our existing research collaborations with home visiting programs, 2) expertise in conducting CVH interventions, 3) participation in other large, multi-site collaborative projects, and 4) the disproportionate CVD burden experienced in AL, we are uniquely-positioned to contribute to this important initiative to identify effective and scalable solutions to improve CVH among women and children.