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National Heart, Lung, and Blood Institute (NHLBI)

The Division of Cardiovascular Sciences within the National Heart, Lung, and Blood Institute (NHLBI) intends to publish a milestone-driven Funding Opportunity Announcement (FOA) to invite applications for research on Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite (UG3/UH3 Clinical Trial Required) and a companion FOA for a Coordinating Center (U24 Clinical Trial Not Required).

The FOAs are expected to be published in winter 2021 with an expected application due date in spring 2021.

This Notice of Intent to Publish is to enable potential applicants sufficient time to develop competitive applications that propose to test the effectiveness of an implementation-ready intervention designed to determine if a cardiovascular health (CVH) promotion module delivered within the context of a home visiting program can enhance maternal and early childhood CVH and address CVH disparities in mothers and children (0-5 years). The study population includes those who are of low socioeconomic status, or live in low resource or underserved rural or urban communities, or in diverse geographic regions of the U.S. with a high burden of cardiovascular disease risk factors. A FOA for clinical trials (UG3/UH3) will run in parallel with a companion FOA for an ENRICH Research Coordinating Center (U24).

Key characteristics of the bi-phasic UG3/UH3 cooperative agreement mechanism (Clinical Trial Required) are that the FOA will support a milestone-driven planning phase (UG3), including feasibility studies and pilot trials for up to 2 years, with possible transition to an implementation phase (UH3) for up to five additional years. The total period of support may be up to 7 years. Only UG3 trials that meet NHLBI-approved scientific milestones and award requirements of the UG3 phase may transition to the UH3 phase. Applications must address planned activities for both the UG3 and UH3 phases.

Details of the planned FOAs are provided below.

This Notice encourages investigators with expertise and insights into the area of Maternal and Child Health to begin to consider applying for these new FOAs.

Collaborative investigations combining expertise in Pediatrics, OBGYN, Cardiovascular Health Promotion Research, Behavioral Science, Social Work, Community Health Promotion, and Home Visiting Research are strongly encouraged.

This Notice of Intent to Publish provides an opportunity for potential investigators to begin the process of building partnerships with federal home visiting maternal and child health program models (https://homvee.acf.hhs.gov/) and to develop plans for leveraging such programs for maternal and child health interventions to promote and preserve cardiovascular health.

The anticipated set of FOAs will support several Clinical Centers that will be responsible for proposing trials, participating in trial protocol development, conducting research, planning and establishing community partnerships and collaborating with home visiting organizations, planning and promoting staff skills development opportunities, and conducting feasibility and pilot studies. During the UG3 phase, multiple sites that receive the UG3 award will develop one common protocol that is designed with the flexibility that would allow use across multiple collaborating sites during the UH3 phase. Applications must include proposed plans for the evaluation and analysis of UG3 intervention phase to inform the study design and analytic plan for the UH3 collaborative phase.

Among the areas of research encouraged are family- and community-based effectiveness-implementation interventions to promote ideal cardiovascular health of mothers and children, 0-5 years of age; and interventions that address maternal cardiovascular health risks such as pre-eclampsia, obesity or gestational diabetes, and which link home visiting with primary care to improve cardiometabolic health of mothers and children.

Research topics of interest include, but are not limited to:

• Test community based effectiveness-implementation intervention strategies that use the home visiting model to promote CVH in mothers (e.g., from poor to intermediate to ideal) and preserve CVH in children 0-5 years of age by implementing interventions that improve the quality of diet and sleep, reduce sedentary behavior, reduce exposure to smoking or second-hand smoke, and prevent excessive weight gain and thereby address disparities in CVH
• Test interventions in high-risk mothers with pre-eclampsia, gestational diabetes or excessive weight gain and assess cardiovascular risk during and post-pregnancy and in their children
• Test whether linking and integrating home visiting with primary care providers enhances clinical implementation and adoption of healthy behaviors, improves cardiometabolic health of mothers and children, and reduces maternal morbidity
• Improve understanding of how to tailor the implementation of evidence-based home-visiting programs to diverse populations with heterogeneous strengths and challenges
• Conduct home visiting interventions, including use of telehealth approaches, to test what works best, for which families, under what conditions, and which assess ideal CVH metrics, social determinants of health, resilience, and other factors
• Conduct family-based home visiting trials, including virtual interventions, in low resourced communities, (e.g., rural communities and Federally Qualified Health Centers) with the goal of addressing CVH disparities and sustaining interventions
• Improve understanding of how to tailor the implementation of evidence-based home-visiting programs (https://homvee.acf.hhs.gov/) to address issues related to the promotion of good CVH
• Test the combined effects of proven-effective CVH modalities with digital health tools/mobile technologies designed to enhance intervention adherence
• Examine facilitators and barriers of sustained adoption, acceptability, reach, and intervention fit and fidelity of delivery using validated theoretical or conceptual implementation research frameworks (e.g., the RE-AIM framework) to improve CVH disparities in mothers and children 0 to 5 years

The anticipated U24 FOA will support one ENRICH Research Coordinating Center (RCC). A detailed description of the coordinating functions will be expected in applications to this FOA. Among the responsibilities of the RCC will be to facilitate communication and collaborations among investigators; plan and support coordinating structure and functions including NHLBI-appointed Data and Safety Monitoring Board meetings with investigators and project scientists; provide relevant skills development for study staff, including interventionists, home delivery staff, early stage investigators, and data collectors; and establish a common and flexible intervention protocol to be approved by the DSMB prior to UH3 phase for the clinical sites. The RCC will also be expected to develop and execute use of common data elements and measures across studies and implement data collection procedures; establish a central database, conduct data analysis and enable reporting of trial results, including process, impact, and outcomes measures. Establishment of public access data files on biospecimens will also be expected to be made available in the NHLBI data repository.

Applications are not being solicited at this time.

Please direct all inquiries to:

Charlotte A. Pratt
National Heart, Lung, and Blood Institute (NHLBI)
(301) 435-0382
NHLBI_Enrich@nhlbi.nih.gov

Tawana McKeither
NHLBI Office of Grants Management
301-827-9238
mckeitherta@mail.nih.gov