N/A
Completed N=117
Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children
Obesity, Maternal · Hypertension in Pregnancy · Hypertension, Pregnancy-Induced · Diabetes
Source: ClinicalTrials.gov NCT05473767 ↗
Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Change in Postpartum Weight Retention — -.73; .29 Pounds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Postpartum Weight Retention |
-.73; .29 | — |
| SECONDARY Weight at 6 Months Postpartum |
200.2; 202.1 | — |
| SECONDARY Weight Change From First Measured Prenatal Weight to 6 Months Postpartum |
11.5; 1.98 | — |
| SECONDARY Change in Self-reported Pre-pregnancy Weight to 6 Months Postpartum |
13.1; 4.7 | — |
| SECONDARY Change in Blood Pressure From Post-delivery to 6 Months. |
-1.76; -1.4; -1.38; -3.59 | — |
| SECONDARY Change in Blood Pressure From First Prenatal Visit to 6 Months. |
-6.3; -.20; 8.3; 8.8 | — |
| SECONDARY Blood Pressure at 6 Months Post-partum |
117.4; 119.1; 78.5; 79.8 | — |
| SECONDARY BMI at 6 Months Post-partum |
32.7; 32.9 | — |
| SECONDARY Change in Eating Behaviors |
-.50; .39 | — |
| SECONDARY Change in Physical Activity |
20.2; 27.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
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.
Data sourced from ClinicalTrials.gov (NCT05473767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.