Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children (ENRICH)
Overview
- Phase
- Not Applicable
- Intervention
- Family Check-Up
- Conditions
- Obesity, Maternal
- Sponsor
- University of Pittsburgh
- Enrollment
- 117
- Locations
- 3
- Primary Endpoint
- Change in Postpartum Weight Retention
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief 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.
Detailed Description
This randomized-controlled pilot study will examine the implementation of a cardiovascular health intervention on pregnant and postpartum mothers. 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. A second goal of the hybrid study is to understand the reach, engagement, and context for implementation of Family Check-Up Heart and gather information for development of the multi-center home visiting model trial. The Family Check-Up Heart program is intended to improve the cardiovascular health of low-income mothers compared to the traditional Family Check-Up and other home visiting programs by incorporating individualized, culturally competent interventions that target diet and exercise, blood pressure control, stress management and self-care, and smoking cessation. The intervention includes cardiovascular assessment and feedback, followed by a tailored treatment program delivered by family coaches in 3-4 week modules to establish goals and track progress. These sessions will work towards obtaining positive cardiovascular health outcomes and empowering mothers of infants to achieve their goals through education and a connection to resources which the investigators hypothesize will also preserve child cardiovascular health. Primary analyses will assess the impact of Family Check-Up Heart on maternal cardiovascular health outcomes when the child is 6 months old compared to Family Check-Up alone.
Investigators
Janet Catov
Associate Professor
University of Pittsburgh
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.
Arms & Interventions
Family Check Up Control
The Family Check-Up is a home visiting program that typically takes place over the course of 3-5 sessions - An initial interview, assessment, feedback session, and optional treatment sessions. The Family Check-Up is designed to support child development and improve parental well-being.
Intervention: Family Check-Up
Family Check-Up Heart
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
Intervention: Family Check Up Heart
Outcomes
Primary Outcomes
Change in Postpartum Weight Retention
Time Frame: Baseline to 6 months post-partum
Weight change from post-delivery to 6 months; both will be measured by the study using validated Bluetooth devices and following standardized research protocols. Mean difference scores are reported.
Secondary Outcomes
- Weight at 6 Months Postpartum(6 months post-partum)
- Weight Change From First Measured Prenatal Weight to 6 Months Postpartum(Baseline to 6 months post-partum)
- Change in Self-reported Pre-pregnancy Weight to 6 Months Postpartum(Baseline to 6 months post-partum)
- Change in Eating Behaviors(Baseline to 6 months post-partum)
- Change in Blood Pressure From Post-delivery to 6 Months.(Baseline to 6 months post-partum)
- Change in Blood Pressure From First Prenatal Visit to 6 Months.(Baseline to 6 months post-partum)
- Blood Pressure at 6 Months Post-partum(6 months post-partum)
- BMI at 6 Months Post-partum(6 months post-partum)
- Change in Physical Activity(Baseline to 6 months post-partum)