Early Intervention to Promote Cardiovascular Health of Mothers and Children

Last updated: July 8, 2024
Sponsor: JHSPH Center for Clinical Trials
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ENRICH

Usual Home Visiting

Routine home visiting

Clinical Study ID

NCT06272045
IRB00398712
5U24HL163114-02
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be currently enrolled in an evidence-based home visiting program participating inENRICH

  2. Be pregnant, with a single or multifetal gestation, at or less than 34 weeks 0 daysgestation (per self-report at time of consent)

  3. Be 18 years of age or older

  4. Speak English or Spanish

Exclusion

Exclusion Criteria: There are no exclusion criteria being applied in assessing eligibility for participation in ENRICH.

Study Design

Total Participants: 6618
Treatment Group(s): 4
Primary Treatment: ENRICH
Phase:
Study Start date:
June 19, 2024
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • California Polytechnic Institute

    San Luis Obispo, California 93407
    United States

    Site Not Available

  • California Polytechnic State University

    San Luis Obispo, California 93407
    United States

    Active - Recruiting

  • Colorado University

    Aurora, Colorado 80045-7464
    United States

    Site Not Available

  • University of Colorado

    Aurora, Colorado 80204
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60208
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Washington University in St. Louis

    Saint Louis, Missouri 63130
    United States

    Active - Recruiting

  • Wake Forest University

    Winston-Salem, North Carolina 27109
    United States

    Active - Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15260
    United States

    Active - Recruiting

  • Pennsylvania State University

    State College, Pennsylvania 16801
    United States

    Active - Recruiting

  • Brown University/Lifespan

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Lifespan

    Providence, Rhode Island 02903
    United States

    Site Not Available

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