Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06272045

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

Led by JHSPH Center for Clinical Trials · Updated on 2026-04-13

6618

Participants Needed

9

Research Sites

52 weeks

Total Duration

On this page

Sponsors

J

JHSPH Center for Clinical Trials

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a home visiting intervention aimed at improving cardiovascular health for mothers and their children. This cluster randomized clinical trial, called Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH), is funded by the National Heart Lung & Blood Institute. It seeks to reduce disparities in maternal and early childhood cardiovascular health by working with community programs where cardiovascular disease risk factors are common. The study compares two groups: one receiving home visits enriched with cardiovascular health promotion content and one receiving usual home visits without this added content. The enhanced intervention starts during pregnancy and continues until children turn 2 years old. It includes information on healthy eating, physical activity, weight management, tobacco use, sleep, and stress reduction. Participants also receive tools such as scales, Fitbits, and blood pressure monitors to help with self-monitoring, along with guidance on infant nutrition, feeding, growth, and emotional care. Participants include mother-child pairs recruited from evidence-based home visiting programs. Researchers will assess outcomes like parent physical activity, diet quality using the Mediterranean Eating Pattern for Americans scale, body mass index, and blood pressure at 12 months after birth. Child body mass index will also be measured at 24 months. The study uses double masking and randomization to assign groups. Participation involves regular home visits and monitoring over the first two years after birth, with study-related assessments during this time.

CONDITIONS

Brief Title

Early Intervention to Promote Cardiovascular Health of Mothers and Children

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently enrolled in an evidence-based home visiting program participating in ENRICH
  • Pregnant with a single or multifetal gestation at or less than 34 weeks 0 days gestation
  • 18 years of age or older
  • Speak English or Spanish
Not Eligible

You will not qualify if you...

  • No exclusion criteria applied for participation in ENRICH

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - From pregnancy until child is 2 years old

Participants receive home visiting services that include cardiovascular health promotion content starting in pregnancy and continuing until their child turns 2 years old.

Routine home visits over the intervention period

Trial Site Locations

Total: 9 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

California Polytechnic State University

San Luis Obispo, California, United States, 93407

Actively Recruiting

3

University of Colorado

Aurora, Colorado, United States, 80204

Actively Recruiting

4

Northwestern University

Chicago, Illinois, United States, 60208

Actively Recruiting

5

Washington University in St. Louis

St Louis, Missouri, United States, 63130

Actively Recruiting

6

Wake Forest University

Winston-Salem, North Carolina, United States, 27109

Actively Recruiting

7

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15260

Actively Recruiting

8

Pennsylvania State University

State College, Pennsylvania, United States, 16801

Actively Recruiting

9

Brown University/Lifespan

Providence, Rhode Island, United States, 02903

Actively Recruiting

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Research Team

L

Lori Burrell, MSW

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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