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Early Intervention to Promote Cardiovascular Health of Mothers and Children

NCT06272045 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6618

Last updated 2026-04-13

No results posted yet for this study

Summary

Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung \& Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6618 participants in total (i.e., 3309 mother-child dyads which includes 3309 mothers and 3309 children) from diverse community settings with a high burden of cardiovascular disease risk factors.

Conditions

  • Cardiovascular Health

Interventions

BEHAVIORAL

ENRICH

In the ENRICH intervention, home visitors will incorporate heart health information and activities into routine home visits beginning in pregnancy and continuing until children turn 2 years old. The intervention includes 1) Information and resources on topics such as healthy eating, physical activity, weight management, tobacco use, healthy sleep and stress reduction, 2) tools like scales, Fitbits, and blood pressure monitors to facilitate self-monitoring, and 3) activities and information focused on infant nutrition, feeding, healthy growth, sleep, play and emotions and soothing.

BEHAVIORAL

Usual Home Visiting

Usual home visiting without cardiovascular health promotion content

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • JHSPH Center for Clinical Trials

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2028-03-30
Completion
2029-03-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06272045 on ClinicalTrials.gov