Recruiting

Home Visiting Intervention

Sponsor:

JHSPH Center for Clinical Trials

Code:

NCT06272045

Conditions

Cardiovascular Health

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

ENRICH

Usual Home Visiting

Study Details

Brief 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

Study ID

NCT06272045

Start date

Jun 19, 2024

Status verified date

Apr, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

6618 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

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.

Usual Home Visiting

Usual home visiting without cardiovascular health promotion content

Primary outcome measure

  • Parent physical activity [ Time Frame: 12 months after birth ]
  • Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale [ Time Frame: 12 months after birth ]
  • Parent body mass index [ Time Frame: 12 months after birth ]
  • Parent blood pressure [ Time Frame: 12 months after birth ]

Central Contacts and Locations

Central contacts

Lori Burrell, MSW

724-858-8201lburrel1@jh.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Amy Dobelstein

205-975-1059adobelst@uabmc.edu

Principal Investigator:

Gareth Dutton

California Polytechnic State University

Recruiting

San Luis Obispo, California, United States, 93407

Contacts

Noemi Alarcon

805-756-5694noalarco@calpoly.edu

Principal Investigator:

Suzanne Phelan

University of Colorado

Recruiting

Aurora, Colorado, United States, 80204

Contacts

Natalie Murphy

970-581-3018NATALIE.MURPHY@CUANSCHUTZ.EDU

Principal Investigator:

Mandy Allison

Northwestern University

Recruiting

Chicago, Illinois, United States, 60208

Contacts

Katharine Maroun

312-503-3019katharine.maroun@northwestern.edu

Principal Investigator:

Darius Tandon

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Cindy Schwartz

314-346-7101cschwarz@wustl.edu

Principal Investigator:

Debra Haire-Joshu

Wake Forest University

Recruiting

Winston-Salem, North Carolina, United States, 27109

Contacts

Natalie Murphy

970-581-3018NATALIE.MURPHY@CUANSCHUTZ.EDU

Principal Investigator:

Katherine Sauder

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contacts

Brianna Natale

412-624-4020bnn11@pitt.edu

Principal Investigator:

Janet Catov

Pennsylvania State University

Recruiting

State College, Pennsylvania, United States, 16801

Contacts

Lindsey Hess

814-934-7631lbb135@psu.edu

Principal Investigator:

Ian Paul

Brown University/Lifespan

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Angelica McHugh

401-793-8978amchugh1@lifespan.org

Principal Investigator:

Stephanie Parade

More Information

Sponsor

JHSPH Center for Clinical Trials

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Home visiting, cardiovascular health, prevention, maternal-child health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by JHSPH Center for Clinical Trials on 2026-04-13.