RecruitingNot ApplicableNCT06272045

Early Intervention to Promote Cardiovascular Health of Mothers and Children

Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)


Sponsor

JHSPH Center for Clinical Trials

Enrollment

6,618 participants

Start Date

Jun 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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

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Interventions

BEHAVIORALENRICH

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.

BEHAVIORALUsual Home Visiting

Usual home visiting without cardiovascular health promotion content


Locations(9)

University of Alabama at Birmingham

Birmingham, Alabama, United States

California Polytechnic State University

San Luis Obispo, California, United States

University of Colorado

Aurora, Colorado, United States

Northwestern University

Chicago, Illinois, United States

Washington University in St. Louis

St Louis, Missouri, United States

Wake Forest University

Winston-Salem, North Carolina, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Pennsylvania State University

State College, Pennsylvania, United States

Brown University/Lifespan

Providence, Rhode Island, United States

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NCT06272045


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