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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06272045
Other study ID # IRB00398712
Secondary ID 5U24HL163114-02
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date July 2028

Study information

Verified date February 2024
Source JHSPH Center for Clinical Trials
Contact Lori Burrell, MSW
Phone 724-858-8201
Email lburrel1@jh.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 6400
Est. completion date July 2028
Est. primary completion date September 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Enriched home visiting
Enriched home visiting with cardiovascular health promotion content
Routine home visiting
Home visiting without cardiovascular health promotion content

Locations

Country Name City State
United States Colorado University Aurora Colorado
United States Northwestern University Chicago Illinois
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Lifespan Providence Rhode Island
United States Washington University Saint Louis Missouri
United States California Polytechnic Institute San Luis Obispo California
United States Pennsylvania State University State College Pennsylvania
United States Wake Forest University Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
JHSPH Center for Clinical Trials National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parent physical activity Time spent in moderate and vigorous physical activity in parent participants 12 months after birth
Primary 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
Primary Parent body mass index Body mass index (BMI) of parent participants 12 months after birth
Primary Parent blood pressure blood pressure (BP) in parent participants 12 months after birth
Secondary Child body mass index body mass index in child 24 months old
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