Early Intervention to Promote Cardiovascular Health of Mothers and Children
ENRICH
2 other identifiers
interventional
6,618
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2024
CompletedFirst Posted
Study publicly available on registry
February 22, 2024
CompletedStudy Start
First participant enrolled
June 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2029
April 13, 2026
April 1, 2026
3.8 years
February 15, 2024
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Parent physical activity
Time spent in moderate and vigorous physical activity in parent participants
12 months after birth
Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale
Diet quality among parent participants as measured by Mediterranean Eating Pattern for Americans (MEPA) scale. The MEPA is a 16-item dietary screener designed to assess accordance with the Mediterranean-like diet patterns during the past 7 days among adults. A score of '0' will be given if the scoring condition is not met and a score of '1' will be given if the scoring condition is met. A score of '1' for any given item was indicative of Mediterranean-like diet accordance. If any condition was not met, a score of '0' was recorded for that item. The total MEPA score could range from 0 to 16. Scores will be converted to points on a 100-point scale based on quantiles of the 16-item measure. For example, scores from 0-3 (0 points), 4-7 (25 points), 8-11 (50 points), 12-14 (80 points), and 15-16 (100 points). Higher scores mean that the adult's diet is similar to a Mediterranean diet.
12 months after birth
Parent body mass index
Body mass index (BMI) of parent participants
12 months after birth
Parent blood pressure
blood pressure (BP) in parent participants
12 months after birth
Secondary Outcomes (1)
Child body mass index
24 months old
Study Arms (2)
ENRICHed home visiting
EXPERIMENTALHome Visiting with the addition of cardiovascular health promotion content
Usual Home Visiting
ACTIVE COMPARATORUsual home visiting without cardiovascular health promotion content
Interventions
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 without cardiovascular health promotion content
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
California Polytechnic State University
San Luis Obispo, California, 93407, United States
University of Colorado
Aurora, Colorado, 80204, United States
Northwestern University
Chicago, Illinois, 60208, United States
Washington University in St. Louis
St Louis, Missouri, 63130, United States
Wake Forest University
Winston-Salem, North Carolina, 27109, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
Pennsylvania State University
State College, Pennsylvania, 16801, United States
Brown University/Lifespan
Providence, Rhode Island, 02903, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- cluster randomized at the home visiting supervisor level, stratified within home visiting agencies Participants are masked throughout the study enrollment process (e.g., recruitment, consent, and baseline data collection). Participant may become unmasked to treatment arm after enrollment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2024
First Posted
February 22, 2024
Study Start
June 19, 2024
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
March 30, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share