This Funding Opportunity Announcement (FOA) invites applications for clinical or community sites to be part of a multi-center group- or cluster-randomized trial under the Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) program. ENRICH will aim to test the effectiveness of an implementation-ready intervention designed to promote cardiovascular health (CVH) and address CVH disparities in both mothers and children (0-5 years old) who are of low socio-economic status (SES), live in low-resource rural or urban communities, or who are in diverse geographic regions of the U.S. with high burden of cardiovascular disease (CVD) risk factors. Specifically, this initiative will support multi-site interventions designed to determine if a CVH module delivered within the context of a home visiting program can enhance maternal and early childhood CVH.
This FOA uses the bi-phasic, milestone-driven cooperative agreement mechanism (UG3/UH3) and runs in parallel with a companion FOA (RFA-HL-22-008) that encourages applications for a collaborating Resource Coordinating Center (RCC). Awards made under this FOA will support a milestone driven planning phase including feasibility studies and pilot activities for up to 2 years (UG3), with possible transition to an implementation phase (UH3) for up to five additional years. Only UG3 trials that meet the scientific milestones and award requirements of the UG3 may transition to the UH3 phase. Applications submitted to this FOA must address both the UG3 and UH3 phases. Applications must also include plans for project management, subject recruitment and retention, scientific conduct of the trial including study design, intervention, measurement and data analysis, and performance milestones for each phase.
Maternal morbidity and mortality rates in the U.S. have risen in recent years. Racial disparities in maternal mortality are particularly alarming, with African Americans having more than 3-fold and American Indians/Alaskan Natives more than 2-fold higher rates compared with non-Hispanic Whites. More women at older ages, or with chronic conditions, such as diabetes, hypertension, or obesity are becoming pregnant– all risk factors for maternal morbidity and mortality. In addition to adverse pregnancy outcomes and poor peri-partum health, maternal obesity, pre-eclampsia and gestational diabetes are also associated with long-term risk of CVD in the mother. Many research reports have noted that women who had pre-eclampsia had significantly higher risk of adverse cardiovascular health (CVH) outcomes 15 years later compared to controls who did not have pre-eclampsia, and maternal pre-eclampsia, gestational diabetes, or hypertension, are associated with risk of high blood pressure in mothers post pregnancy and in their children as early as 3 years of age. There are also evidence-based guidelines recommending both behavioral and pharmacological interventions targeted at cardiovascular and maternal risk factors and chronic conditions such as obesity, hypertension, and diabetes.
Epidemiologic studies in children support the conclusion that the development of cardiometabolic risk factors begins in utero and early childhood, progresses from childhood through adolescence and into adulthood, and results in adverse clinical CVH outcomes. Beginning prenatally and in childhood, unhealthy behaviors such as poor diet and nutrition, sedentary behavior and lack of physical activity, sleep timing and disruptions, and smoking exposures (e.g., second-hand smoke exposures); health factors such as obesity, elevated blood pressure, glucose and lipids in the mother; and social determinants of health (e.g., poor access to health care) all contribute to the loss of ideal CVH. The associated loss of CVH prenatally and postpartum is accelerated by poor lifestyle behaviors and inadequate adherence to evidence-based guideline recommendations such as the treatment of hypertension or smoking cessation. The loss of CVH is also exacerbated by adverse social determinants of health indicators, including poverty, poor access to or utilization of health services, and contextual factors within the home and in social and community environments. These adverse exposures have direct effects on CVH and constrain behavioral options leading to further deterioration in CVH. Strategies that optimize and promote CVH and reduce the adverse effects of social determinants of health indicators have the potential to reduce health disparities, reduce maternal morbidity, and improve the health and well-being of infants and children in a way that could be sustained across the lifespan.
URL for more information:
Filed Under: Funding Opportunities