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

NCT05473767 | Completed Results DMC

• 2 other identifiers: STUDY220200961UG3HL163116-01
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Cardiovascular health; Postpartum women; Health Promotion

Outcome Measures

Primary Outcomes (1)

• Change in Postpartum Weight Retention

  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.

  Baseline to 6 months post-partum

Secondary Outcomes (9)

• 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 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

Study Arms (2)

Family Check Up Control

ACTIVE COMPARATOR

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.

Behavioral: Family Check-Up

Family Check-Up Heart

EXPERIMENTAL

Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.

Behavioral: Family Check Up Heart

Interventions

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.

Family Check Up Control

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 Heart

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Healthy Start, Inc.

Pittsburgh, Pennsylvania, 15208, United States

Location

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Women, Infants, and Children Program

Pittsburgh, Pennsylvania, 15222, United States

Location

Related Publications (2)

• Segal-Isaacson CJ, Wylie-Rosett J, Gans KM. Validation of a short dietary assessment questionnaire: the Rapid Eating and Activity Assessment for Participants short version (REAP-S). Diabetes Educ. 2004 Sep-Oct;30(5):774, 776, 778 passim. doi: 10.1177/014572170403000512. No abstract available.

  PMID: 15510530 BACKGROUND

• Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sports Exerc. 2004 Oct;36(10):1750-60. doi: 10.1249/01.mss.0000142303.49306.0d.

  PMID: 15595297 BACKGROUND

MeSH Terms

Conditions

Pregnancy in Obesity; Hypertension, Pregnancy-Induced; Diabetes Mellitus; Overweight

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Limitations of the study include the small sample size and the short duration of intervention.

Results Point of Contact

• Title: Janet M Catov, PhD MS
• Organization: University of Pittsburgh

catovjm@mwri.magee.edu

412-641-6217

Study Officials

• Janet M Catov, PhD

  UPMC Magee Womens Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators will be blind to group assignment during intervention delivery and assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a randomized controlled trial pilot study that will randomize 100 women into Family Check-Up Heart and 50 women into traditional Family Check-Up. The investigators will use an unbalanced design to enhance ability to evaluate feasibility and acceptability for the new Family Check-Up Heart intervention. The investigators will utilize a Type 1 hybrid effectiveness-implementation design using mixed methods that will simultaneously assess both the implementation of the Family Check-Up Heart and preliminary effectiveness on 6-month maternal cardiovascular health outcomes.

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 26, 2022
• Study Start: November 18, 2022
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: January 12, 2026
• Results First Posted: January 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: We will share data within two years of the end of our funding to allow time for analysis and dissemination of findings.
• Access Criteria: Interested investigators seek written approval from the study Principle Investigators. An Institutional Review Board protocol approved by their institution or a signed data sharing agreement is needed to access the data.

Locations

US (3)