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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ENRICHed home visiting 		Home Visiting with the addition of cardiovascular health promotion content
  • Behavioral: ENRICH
    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.
Active Comparator
Usual Home Visiting 		Usual home visiting without cardiovascular health promotion content
  • Behavioral: Usual Home Visiting
    Usual home visiting without cardiovascular health promotion content

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Amy Dobelstein
205-975-1059
adobelst@uabmc.edu

More Details

Status
Recruiting
Sponsor
JHSPH Center for Clinical Trials

Study Contact

Lori Burrell, MSW
724-858-8201
lburrel1@jh.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.