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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Overweight; Hypertension, Pregnancy-Induced; Hypertension in Pregnancy; Obesity, Maternal
• Intervention / Treatment: Behavioral: Family Check-Up; Behavioral: Family Check Up Heart

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital
    • Pittsburgh, Pennsylvania, United States, 15208
      • Healthy Start, Inc.
    • Pittsburgh, Pennsylvania, United States, 15222
      • Women, Infants, and Children Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult inclusion criteria:

  1. 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.
  2. Medicaid-eligible
  3. Speak English.
  4. Resident of Allegheny County, Pennsylvania.
  5. 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:

1. Children birth through 2 months who reside in Allegheny County may enroll in the program if their mother is participating in the study.
2. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Family Check-Up; 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.
Experimental: Family Check-Up Heart; Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.	Behavioral: Family Check Up Heart; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight at 6 Months Postpartum	Weight at 6 months will be assessed by the study using validated Bluetooth devices and following standardized research protocols.	6 months post-partum
Weight Change From First Measured Prenatal Weight to 6 Months Postpartum	First measured prenatal weight will be obtained from the participant's medical record at baseline. Weight at 6 months will be assessed by the study using validated Bluetooth devices and following standardized research protocols. Mean difference scores are reported.	Baseline to 6 months post-partum
Change in Self-reported Pre-pregnancy Weight to 6 Months Postpartum	Pre-pregnancy weight will be self-reported at the baseline assessment. Weight at 6 months post-partum will be assessed by the study using validated Bluetooth devices and following standardized research protocols. Mean difference scores are reported.	Baseline to 6 months post-partum
Change in Blood Pressure From Post-delivery to 6 Months.	Blood pressure will be measured by the study at baseline and again at 6-months post-partum using validated Bluetooth devices and following standardized research protocols. Mean difference scores are reported.	Baseline to 6 months post-partum
Change in Blood Pressure From First Prenatal Visit to 6 Months.	First measured prenatal blood pressure will be obtained from the participant's medical record at baseline. Blood pressure at 6 months post-partum will be assessed by the study using validated Bluetooth devices and following standardized research protocols. Mean difference scores are reported.	Baseline to 6 months post-partum
Blood Pressure at 6 Months Post-partum	Blood pressure at 6 months post-partum will be assessed by the study using validated Bluetooth devices and following standardized research protocols.	6 months post-partum
BMI at 6 Months Post-partum	Height and Weight at 6 months post-partum will be assessed by the study using a validated Bluetooth scale and following standardized research protocols.	6 months post-partum
Change in Eating Behaviors	Eating behaviors will be assessed at baseline and 6 months post-partum using the Rapid Eating Assessment for Participants - Shortened Version. The Rapid Eating Assessment for Participants is a 16-item self-report scale assessing frequency of various eating behaviors such as skipping breakfast and eating fried foods. Items are rated on a 3-point response scale ranging from Usually/Often (1) to Rarely/Never (3). Three items also have a "Does not apply to me" option which is also coded as a 3. An example of an item with this option is "Eat more than 8 ounces of meat, chicken, turkey, or fish per day." The first 13 items are summed to create a score where higher values indicate healthier eating behaviors. Minimum and maximum scores are 13 and 39, respectively. Mean difference scores are reported.	Baseline to 6 months post-partum
Change in Physical Activity	Physical activity will be measured using the Pregnancy Physical Activity Questionnaire. The Pregnancy Physical Activity Questionnaire is a 26-item self-report of activities such as jogging or running, dancing, and watching television or a video. Items are rated on a 6-point likert-type scale ranging from Never to 3 or more hours per day. Responses are weighted to generate metabolic equivalent codes. Specifically, the self-reported time spent in each activity will be multiplied by its intensity to arrive at a measure of average weekly energy expenditure attributable to each activity. The metabolic equivalent codes are then summed to create a physical activity score where higher values indicate greater physical activity. Minimum and maximum scores are 0 and 308.85, respectively. Mean difference scores are reported.	Baseline to 6 months post-partum

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Janet M Catov, PhD, UPMC Magee Womens Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): November 22, 2024
• Study Completion (Actual): November 22, 2024

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Health Promotion; Postpartum women; Cardiovascular health
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Overnutrition; Body Weight; Pregnancy Complications; Glucose Metabolism Disorders; Obesity; Hypertension; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Hypertension, Pregnancy-Induced; Diabetes Mellitus; Pregnancy in Obesity
• Other Study ID Numbers: STUDY22020096; 1UG3HL163116-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following the requirements of the University of Pittsburgh Institutional Review Board, investigators may access de-identified data following request and approval by the study Principle Investigators. All data will be shared, except when deemed protected health information. For example, maternal age at delivery will be shared by not date of birth or date of delivery (only year). The Principle Investigators will oversee data sharing to ensure no personally identifiable information is shared, and the study data manager has protocols to implement these processes.
• IPD Sharing Time Frame: We will share data within two years of the end of our funding to allow time for analysis and dissemination of findings.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No