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

Not Applicable

Completed

• Conditions: Obesity, Maternal; Hypertension, Pregnancy-Induced; Hypertension in Pregnancy; Diabetes; Overweight
• Interventions: Behavioral: Family Check Up Heart; Behavioral: Family Check-Up

• Registration Number: NCT05473767
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-26
• Study Start: 2022-11-18
• Primary Completion: 2024-11-22
• Study Completion: 2024-11-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family Check-Up Heart	Family Check Up Heart	Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
Family Check Up Control	Family Check-Up	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.

Primary Outcome Measures

Name	Time	Method
Change in postpartum weight retention	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure at 6 months post-partum	Baseline to 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.
Weight at 6 months postpartum	6 months post-partum	Weight at 6 months will be assessed by the study using validated Bluetooth devices and following standardized research protocols.
Change in self-reported pre-pregnancy weight to 6 months postpartum	Baseline to 6 months post-partum	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.
Weight change from first measured prenatal weight to 6 months postpartum	Baseline to 6 months post-partum	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.
Change in blood pressure from post-delivery to 6 months	Baseline to 6 months post-partum	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.
Change in blood pressure from first prenatal visit to 6 months	Baseline to 6 months post-partum	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.
Change in eating behaviors	Baseline to 6 months post-partum	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.
Change in physical activity	Baseline to 6 months post-partum	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.
BMI at 6 months post-partum	Baseline to 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.

Trial Locations

Locations (3)

Healthy Start, Inc.; 🇺🇸 Pittsburgh, Pennsylvania, United States

Magee Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Women, Infants, and Children Program; 🇺🇸 Pittsburgh, Pennsylvania, United States