Early Intervention to Promote Cardiovascular Health of Mothers and Children
NCT ID: NCT06272045
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
6618 participants
INTERVENTIONAL
2024-06-19
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
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.
Study Groups
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ENRICHed home visiting
Home Visiting with the addition of cardiovascular health promotion content
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.
Usual Home Visiting
Usual home visiting without cardiovascular health promotion content
Usual Home Visiting
Usual home visiting without cardiovascular health promotion content
Interventions
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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.
Usual Home Visiting
Usual home visiting without cardiovascular health promotion content
Eligibility Criteria
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Inclusion Criteria
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
18 Years
FEMALE
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
JHSPH Center for Clinical Trials
OTHER
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
California Polytechnic State University
San Luis Obispo, California, United States
University of Colorado
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Washington University in St. Louis
St Louis, Missouri, United States
Wake Forest University
Winston-Salem, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Pennsylvania State University
State College, Pennsylvania, United States
Brown University/Lifespan
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00398712
Identifier Type: -
Identifier Source: org_study_id
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