Healthy Hearts/ Corazones Saludables: Partnership to promote cardiovascular health in Hispanic and non-Hispanic mothers and children in US home visiting programs

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Project Summary/Abstract Cardiovascular disease (CVD) is the leading cause of death in US women, accounting for approximately one of every three female deaths. Obesity is arguably the strongest modifiable target for interventions to prevent CVD and is linked with nearly every other major CVD risk factor, including hypertension, elevated glucose, high cholesterol, poor diet, and physical inactivity. Infants of mothers with obesity are also at increased risk for future obesity and CVD. Our team has developed an empirically validated lifestyle intervention that is remotely delivered and highly successful in reducing body weight and improving CVH in Hispanic and non-Hispanic women and children during pregnancy and postpartum. It is now critical to study ways to disseminate this empirically-validated program. Evidence based home visiting programs (EBHV), which support families from the prenatal period through infancy and early childhood, are an ideal setting to promote CVH, however these programs were not designed with an explicit focus on the prevention of obesity and other CVD risk factors. The proposed research will test the effectiveness of our pre- and postnatal lifestyle intervention as an enhancement to EBHV to promote maternal and child CVH. During an initial 2-year UG3 phase, we will: 1) modify our pre- and postnatal intervention to focus on CVH within EBHV; 2) Work with our EBHV partners to integrate CVH messages and develop their related skills; 3) Strengthen partnerships between healthcare providers and EBHV to increase referrals, retention, and improve CVH, and 4) Contribute to the development of a high-impact study design for the subsequent UH3 phase involving a multi-cohort protocol, harmonized interventions, measures and resources. For the subsequent UH3 phase, we propose a Hybrid Type 1 effectiveness-implementation trial in which we recruit 550 perinatal women who will be randomized to receive EBHV alone or EBHV enhanced with our lifestyle intervention to promote CVH. Our primary hypothesis is that, over an average of 36 months, EBHV+CVH (vs. EBHV alone) will result in more favorable maternal and child levels of the Life’s Simple 7 indicators. We will also examine key intervention moderators, focusing on social determinants of health, and mediators, including changes in the home environment, social support, CVH behaviors, and program adherence. Using the RE-AIM framework, we will determine reach, effectiveness, adoption, implementation, and maintenance of EBHV+CVH vs. EBHV alone. Other goals are to empower and reduce burnout among home visitors; develop skills of early-stage investigators, and propose innovative ancillary studies to enhance the scientific contributions. Our team is exceptionally well positioned for this research and includes established investigators with decades of experience conducting NIH funded research, outstanding early stage investigators, and EBHV sites from Central California and Rhode Island.