Early Intervention to Promote Cardiovascular Health of Mothers and Children

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
JHSPH Center for Clinical Trials
Study ID
NCT06272045
Status
Recruiting
Apply to this trial

Conditions

  • Cardiovascular Health

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ENRICH — BEHAVIORAL
    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.
  • Usual Home Visiting — BEHAVIORAL
    Usual home visiting without cardiovascular health promotion content

Study Details

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.

Key Dates

Start date
Jun 19, 2024
Status verified
Apr 2026
Primary completion
Mar 30, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
6,618 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: ENRICHed home visiting
    Home Visiting with the addition of cardiovascular health promotion content
  • Active Comparator: Usual Home Visiting
    Usual home visiting without cardiovascular health promotion content

Primary Outcome Measure

Parent physical activity [ Time Frame: 12 months after birth ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Amy Dobelstein
[email protected]
205-975-1059
Gareth Dutton (PRINCIPAL_INVESTIGATOR)
California Polytechnic State UniversitySan Luis ObispoCalifornia93407
Noemi Alarcon
[email protected]
805-756-5694
Suzanne Phelan (PRINCIPAL_INVESTIGATOR)
University of ColoradoAuroraColorado80204
Natalie Murphy
[email protected]
970-581-3018
Mandy Allison (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60208
Katharine Maroun
[email protected]
312-503-3019
Darius Tandon (PRINCIPAL_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63130
Cindy Schwartz
[email protected]
314-346-7101
Debra Haire-Joshu (PRINCIPAL_INVESTIGATOR)
Wake Forest UniversityWinston-SalemNorth Carolina27109
Natalie Murphy
[email protected]
970-581-3018
Katherine Sauder (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15260
Brianna Natale
[email protected]
412-624-4020
Janet Catov (PRINCIPAL_INVESTIGATOR)
Pennsylvania State UniversityState CollegePennsylvania16801
Lindsey Hess
[email protected]
814-934-7631
Ian Paul (PRINCIPAL_INVESTIGATOR)
Brown University/LifespanProvidenceRhode Island02903
Angelica McHugh
[email protected]
401-793-8978
Stephanie Parade (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCalifornia Polytechnic State University· San Luis Obispo, CAUniversity of Colorado· Aurora, CONorthwestern University· Chicago, ILWashington University in St. Louis· St Louis, MOWake Forest University· Winston-Salem, NC

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