Early Intervention to Promote Cardiovascular Health of Mothers and Children
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 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors.
Conditions:
🦠 Cardiovascular Health
🗓️ Study Start (Actual) 19 June 2024
🗓️ Primary Completion (Estimated) September 2027
✅ Study Completion (Estimated) July 2028
👥 Enrollment (Estimated) 6618
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States
📍 San Luis Obispo, California, United States
📍 Aurora, Colorado, United States
📍 Chicago, Illinois, United States
📍 Saint Louis, Missouri, United States
📍 Winston-Salem, North Carolina, United States
📍 Pittsburgh, Pennsylvania, United States
📍 State College, Pennsylvania, United States
📍 Providence, Rhode Island, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Be currently enrolled in an evidence-based home visiting program participating in ENRICH
    • 2. Be pregnant, with a single or multifetal gestation, at or less than 34 weeks 0 days gestation (per self-report at time of consent)
    • 3. Be 18 years of age or older
    • 4. Speak English or Spanish

    Exclusion Criteria:

    Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
    Sexes Eligible for Study: FEMALE
    Accepts Healthy Volunteers: Yes

    🗓️ Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

    Study Registration Dates

    • First Submitted 15 February 2024
    • First Submitted that Met QC Criteria 15 February 2024
    • First Posted 22 February 2024

    Study Record Updates

    • Last Update Submitted that Met QC Criteria 8 July 2024
    • Last Update Posted 10 July 2024
    • Last Verified July 2024