Early Intervention to Promote Cardiovascular Health of Mothers and Children

Cardiovascular Health Clinical Trial

— ENRICH  

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Cardiovascular Health

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