CompletedNot Applicable

Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children

United States117 participantsStarted 2022-11-18

Plain-language summary

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.

Who can participate

SexALL

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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.
✓. 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.

Exclusion criteria

✕. Pregnant women with complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV.
✕. Multifetal pregnancies or deliveries.

What they're measuring

Change in Postpartum Weight Retention

Timeframe: Baseline to 6 months post-partum

Trial details

NCT IDNCT05473767

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-22

Results submitted2025-11-21

View on ClinicalTrials.gov More Obesity, Maternal trials