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Obesity, MaternalNCT05473767

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

A study testing Family Check Up Heart and Family Check-Up in people with Obesity, Maternal and Hypertension in Pregnancy, run by University of Pittsburgh at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Family Check Up Heart and Family Check-Up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
3 sitesUnited States
Study dates
18 Nov 2022to 22 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Healthy Start, Inc.

    Pittsburgh, Pennsylvania, 15208

  • Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Women, Infants, and Children Program

    Pittsburgh, Pennsylvania, 15222

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Family Check Up Heart, Family Check-Up
Keywords
Cardiovascular health, Postpartum women, Health Promotion
Medical subject headings
Pregnancy in Obesity, Hypertension, Pregnancy-Induced, Diabetes Mellitus, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Check Up HeartBehavioural

    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-UpBehavioural

    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 groups in NCT05473767
Study groupRoleWhat they receive
Family Check Up ControlActive comparatorThe 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.
Receives: Behavioral: Family Check-Up
Family Check-Up HeartExperimentalFamily Check-Up Heart combines the traditional Family Check-Up with a heart health component.
Receives: Behavioral: Family Check Up Heart

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 6 months post-partum

Secondary outcomes (9)

  1. Weight at 6 Months Postpartum

    Weight at 6 months will be assessed by the study using validated Bluetooth devices and following standardized research protocols.

    Measured: 6 months post-partum

  2. 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.

    Measured: Baseline to 6 months post-partum

  3. 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.

    Measured: Baseline to 6 months post-partum

  4. 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.

    Measured: Baseline to 6 months post-partum

  5. 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.

    Measured: Baseline to 6 months post-partum

  6. 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.

    Measured: 6 months post-partum

  7. 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.

    Measured: 6 months post-partum

  8. 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.

    Measured: Baseline to 6 months post-partum

  9. 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.

    Measured: Baseline to 6 months post-partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start18 Nov 2022
  3. Primary completion22 Nov 2024
  4. Study completion22 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05473767
Sponsor's protocol ID
STUDY22020096
Other IDs
1UG3HL163116-01
Status last verified
Nov 2025
First submitted
19 Jul 2022
Last updated
12 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 15510530

  • 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.

    PubMed 15595297

Questions about this trial

What is this clinical trial studying?

A study testing Family Check Up Heart and Family Check-Up in people with Obesity, Maternal and Hypertension in Pregnancy, run by University of Pittsburgh at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Postpartum Weight Retention (time frame: Baseline to 6 months post-partum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05473767, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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