Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children
Completed · Not applicable
Conditions studied: Obesity, Maternal, Hypertension in Pregnancy, Hypertension, Pregnancy-Induced, Diabetes, Overweight
In brief
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.
Key facts
- Study ID
- NCT05473767
- Run by
- University of Pittsburgh
- People needed
- 117
- Starts
- 2022-11-18
- Expected to finish
- 2024-11-22
- Last updated by the study team
- 2026-01-12
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Pregnant women with complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV.
- Multifetal pregnancies or deliveries.
Where it is running
- Healthy Start, Inc. — Pittsburgh, Pennsylvania, United States
- Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
- Women, Infants, and Children Program — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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