Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06272045

Early Intervention to Promote Cardiovascular Health of Mothers and Children

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cardiovascular Health

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Parent physical activity

    Time frame: 12 months after birth

    Time spent in moderate and vigorous physical activity in parent participants

  2. Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale

    Time frame: 12 months after birth

    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.

  3. Parent body mass index

    Time frame: 12 months after birth

    Body mass index (BMI) of parent participants

  4. Parent blood pressure

    Time frame: 12 months after birth

    blood pressure (BP) in parent participants

Secondary outcomes

  1. Child body mass index

    Time frame: 24 months old

    body mass index in child

Study contacts

Contact information is provided by the study sponsor or research team.

Lori Burrell, MSW

CONTACT

[email protected]

724-858-8201

Sponsors and collaborators

Lead sponsor

JHSPH Center for Clinical Trials

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: ENRICH

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 22, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.