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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT05473767
Status
Completed

Conditions

  • Diabetes
  • Hypertension in Pregnancy
  • Hypertension, Pregnancy-Induced
  • Obesity, Maternal
  • Overweight

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Family Check Up Heart — BEHAVIORAL
    Family Check-Up Heart consists of the Family Check up with an added heart health component. The Family Check-Up Heart assessment will include evaluations of maternal cardiovascular health; specifically, measurement of maternal blood pressure, body mass index, diet quality, exercise, and smoking, which will be included in the feedback session. After the Feedback Session participants will also receive information about healthy eating and weight loss, stress management, and smoking and to monitor weight and blood pressure.
  • Family Check-Up — BEHAVIORAL
    The Family Check-Up typically takes place over the course of 3-5 sessions, each about an hour long. First, a trained Family Check-Up family coach will conduct an "Initial Interview." Second is an assessment of that includes questionnaires and videotaped interaction tasks. Third, during the Feedback Session, the family coach discusses with the participant strengths and challenges for their child and family as a whole. They then set goals for their family to support and maintain strengths, and to address any areas of concern. After the Feedback Session families have the option to continue meeting with their family coach to support the child's development and improve parental well-being.

Study Details

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 Dates

Start date
Nov 18, 2022
Status verified
Nov 2025
Primary completion
Nov 22, 2024
Completion
Nov 22, 2024

Study Design

Enrollment
117 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Experimental: Family Check-Up Heart
    Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.

Primary Outcome Measure

Change in Postpartum Weight Retention [ Time Frame: Baseline to 6 months post-partum ]

Locations (3)

FacilityCityStateZIPSite coordinators
Healthy Start, Inc.PittsburghPennsylvania15208-
Magee Womens HospitalPittsburghPennsylvania15213-
Women, Infants, and Children ProgramPittsburghPennsylvania15222-

Find similar trials in Pittsburgh, PA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Healthy Start, Inc.· Pittsburgh, PAMagee Womens Hospital· Pittsburgh, PAWomen, Infants, and Children Program· Pittsburgh, PA

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