PROJECT SUMMARY/ABSTRACT
As part of NHLBI’s ENRICH program, this research will test an implementation-ready intervention designed
to improve cardiovascular health (CVH) among high risk mothers and young children during pregnancy and the
first two years after delivery. Home visitation (HV) models meeting federal criteria of evidence of effectiveness
will be leveraged to compare existing HV programs against those with an additional CVH intervention in a
cluster-randomized, multicenter trial.
Our multidisciplinary team has pioneered behavioral and lifestyle interventions for women during
preconception and pregnancy and for infants during the first years after birth including those using HV for the
primary prevention of obesity. We also have extensive research experience linking and integrating community-
based healthcare programs with health system electronic medical records (EMRs). For this proposal, we will
collaborate with two Nurse-Family Partnership agencies in Northern Appalachia, a medically underserved
region with high rates of poverty and poor CVH, including high rates of obesity, heart disease, and tobacco
use. We will enroll ≥500 of the 3000 pregnant women required for the UH3 phase multicenter trial.
During the UG3 phase, we will pilot our proposed intervention with our community partners and work
collaboratively with other ENRICH sites and NHLBI to develop the UH3 phase common protocol. Our proposed
intervention incorporates tenets of Social Cognitive Theory and the Framework for Understanding Poverty
using a skill-building curriculum that includes role modeling, goal-setting, and skill practice opportunities in the
home. Five intervention pillars (Lifestyle Behaviors, Self-Regulation, Responsive Parenting, Home
Environment, EMR Integration) are designed to increase maternal knowledge and self-efficacy in their ability to
establish healthy lifestyle habits and maternal parenting practices to improve CVH. Consistent with a Hybrid
Trial Type 1, the study design aims to understand the context for implementing the intervention. The composite
primary outcome for mothers will be a modified version of the American Heart Association’s Life’s Simple 7 one
year after childbirth; outcomes will also be assessed 2 years postpartum. The childhood primary outcome will
be a composite of seven early life risk factors for poor CVH across with the final assessment at age 2 years.
For these outcomes, the moderating effects of social determinants of health and psychosocial indices on
outcomes will be explored. In addition, the context for implementation will be evaluated and factors influencing
intervention efficacy will be identified to determine in HV, what works best, for whom, in which contexts, why
and how. Lastly, we aim to lead network efforts to link and integrate HV summaries into EMRs to allow for data
sharing with healthcare providers to enhance intervention effectiveness so that the UH3 protocol can evaluate
whether EMR integration with HV programs improves CVH composite indicators as well as health equity.
