NCT05473767Completed
Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children
Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children (ENRICH)
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
This randomized-controlled pilot study will examine the implementation of a cardiovascular health intervention on postpartum mothers and infants. The investigators will adapt a cardiovascular health intervention into an evidence-based home visiting program, Family Check-Up to create Family Check-Up Heart. Through a Type 1 hybrid effectiveness implementation design, the pilot study will test the feasibility and effectiveness of Family Check-Up Heart (Family Check-Up Heart, n=100; Family Check-Up, n=50). The investigators hypothesize that Family Check-Up Heart will show comparable levels of engagement and acceptability as Family Check-Up alone, and mothers receiving Family Check-Up Heart will have greater improvements in cardiovascular health at 6 months postpartum compared to Family Check-Up alone.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 117 (actual)
- First submitted
- 19 Jul 2022
- Start date
- 18 Nov 2022
- Primary completion date
- 22 Nov 2024
- Lead sponsor
- University of Pittsburgh
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT05473767
What you commit to
- Study type: Interventional
- Participants enrolled: 117
- From 18 Nov 2022 to the primary completion date, 22 Nov 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pregnant women with complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV.
Other
- Multifetal pregnancies or deliveries.
Who the study is looking for
- Adult inclusion criteria:
- Pregnant women/birthing people or women/birthing people who have delivered in the past 2 months who deliver at Magee or are enrolled in the Women Infants and Children program in Allegheny County.
- Medicaid-eligible
- Speak English.
- Resident of Allegheny County, Pennsylvania.
- Does not have complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV.
- Participants who consent to enrollment may have their medical history reviewed by study physicians and staff to adjudicate pregnancy outcomes and ensure they meet inclusion criteria before randomization.
- Child inclusion criteria:
- Children birth through 2 months who reside in Allegheny County may enroll in the program if their mother is participating in the study.
- Has a legal guardian who speaks English. This criterion is included because the project's materials and assessments are currently only available in English, with staff only fluent in English.
Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Healthy Start, Inc. Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Magee-Womens Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Women, Infants, and Children Program Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.