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.
