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.
