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