Early Intervention to Promote Cardiovascular Health of Mothers and Children

Poor cardiovascular health (CVH) is highly prevalent among pregnant individuals and is associated with adverse maternal and offspring outcomes. As CVH is already suboptimal by early adolescence, early-life interventions are needed. Interventions conducted in the community by trusted programs have the potential to improve CVH risk factors among perinatal individuals and their children. Home Visiting (HV) programs are trusted maternal and child health providers in diverse US communities, especially among low-income families. This project is part of the National Heart Lung and Blood Institute (NHLBI) Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) consortium. Northwestern University is one seven clinical centers part of the ENRICH consortium. This project is funded via a UG3/UH3 mechanism in which during the UG3 period each clinical center is responsible for conducting a pilot study to inform the development of a common protocol that will be used across all seven clinical centers during the UH3 phase. This clinicaltrials.gov entry describes the pilot RCT protocol. The pilot study will use a randomized controlled trial (RCT) longitudinal design. Forty individuals randomized to the intervention arm will receive usual home visiting services along with the ENRICH intervention. Ten individuals randomized to the control arm will receive usual home visiting without the ENRICH intervention. Among the individuals randomized to the intervention condition, 20 (50%) will receive the entire ENRICH intervention while the other 20 will receive only diet and physical activity content. The varying levels of intervention dosage is being delivered to assess acceptability and feasibility of a more- and less-intensive version of the intervention. Components of the intervention are described below. Assessments will be conducted at baseline, 2-month follow-up, and 4-month follow-up.