NCT05856162

Early Intervention to Promote Cardiovascular Health of Mothers and Children

Early Intervention to Promote Cardiovascular Health of Mothers and Children at Northwestern University

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to examine whether a multi-component intervention delivered during pregnancy and after delivery can improve the cardiovascular health of pregnant individuals enrolled in home visiting programs, as well as their offspring's cardiovascular health. The main questions it aims to answer are: 1. Does a multi-component intervention improve cardiovascular health of pregnant individuals and new mothers enrolled in home visiting programs? 2. Does a multi-component intervention improve cardiovascular health of the offspring of pregnant individuals/new mothers enrolled in home visiting programs? Participants receiving the multi-component intervention will receive content on promoting cardiovascular health delivered by their home visitor and asynchronously. All participants will be asked to complete assessments at baseline, 2-month follow-up, and 4-month follow-up. The investigators will compare whether pregnant individuals and new mothers randomized to the intervention group, and their offspring, exhibit better cardiovascular health than pregnant individuals and new mothers randomized to the control group.

Detailed description

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	ENRICH pilot intervention (full intervention)	The full ENRICH pilot intervention will consist of content related to diet, physical activity, stress/mental health, sleep, tobacco cessation, and child health. The investigators will use an adapted version of the Mothers and Babies stress management intervention to address mental health, an adapted version of the HEALTH curriculum to address diet/physical activity, and an adapted version of the INSIGHT curriculum to address child health.
BEHAVIORAL	ENRICH pilot intervention (partial intervention: only diet and physical activity)	The partial ENRICH intervention will focus only on diet and physical activity.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-05-31
• Completion: 2024-10-31
• First posted: 2023-05-12
• Last updated: 2024-12-13

Locations

1 site across 1 country: United States