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

JHSPH Center for Clinical Trials

Status: Enrolling

Conditions: Cardiovascular Health

Treatments: Behavioral: ENRICH; Behavioral: Usual Home Visiting

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06272045

IRB00398712

5U24HL163114 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 6,618 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,618 participants in 2 patient groups

ENRICHed home visiting

Experimental group

Description:

Home Visiting with the addition of cardiovascular health promotion content

Treatment:

Behavioral: ENRICH

Usual Home Visiting

Active Comparator group

Description:

Usual home visiting without cardiovascular health promotion content

Treatment:

Behavioral: Usual Home Visiting