NCT05473767

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

Completed NA Results posted Last updated 12 January 2026

What this trial tests

NA trial testing Family Check Up Heart in Obesity, Maternal in 117 participants. Completed in 22 November 2024.

Timeline

18 November 2022

Primary endpoint
22 November 2024

22 November 2024

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	117
Start date	18 November 2022
Primary completion	22 November 2024
Estimated completion	22 November 2024
Sites	3 locations across United States

Drugs / interventions tested

• Family Check Up Heart
• Family Check-Up

Conditions studied

• Obesity, Maternal — all drugs for Obesity, Maternal →
• Hypertension in Pregnancy — all drugs for Hypertension in Pregnancy →
• Hypertension, Pregnancy-Induced — all drugs for Hypertension, Pregnancy-Induced →
• Diabetes — all drugs for Diabetes →

Sponsor

University of Pittsburgh

Who can join

Eligibility, any sex, with Obesity, Maternal or Hypertension in Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Postpartum Weight Retention Primary · 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. Mean difference scores are reported.

Group	Value	95% CI
Family Check Up Control	-.73	± 9.9
Family Check-Up Heart	.29	± 14.1

Weight at 6 Months Postpartum Secondary · 6 months post-partum

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

Group	Value	95% CI
Family Check Up Control	200.2	± 70.9
Family Check-Up Heart	202.1	± 58.3

Weight Change From First Measured Prenatal Weight to 6 Months Postpartum Secondary · 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. Mean difference scores are reported.

Group	Value	95% CI
Family Check Up Control	11.5	± 15.2
Family Check-Up Heart	1.98	± 18.9

Change in Self-reported Pre-pregnancy Weight to 6 Months Postpartum Secondary · 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. Mean difference scores are reported.

Group	Value	95% CI
Family Check Up Control	13.1	± 24.2
Family Check-Up Heart	4.7	± 24.2

Change in Blood Pressure From Post-delivery to 6 Months. Secondary · 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. Mean difference scores are reported.

Systolic mmHg

Group	Value	95% CI
Family Check Up Control	-1.76	± 7.4
Family Check-Up Heart	-1.4	± 13.5

Diastolic mmHg

Group	Value	95% CI
Family Check Up Control	-1.38	± 6.8
Family Check-Up Heart	-3.59	± 13.2

Change in Blood Pressure From First Prenatal Visit to 6 Months. Secondary · 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. Mean difference scores are reported.

Systolic mmHg

Group	Value	95% CI
Family Check Up Control	-6.3	± 12.8
Family Check-Up Heart	-.20	± 14.4

Diastolic mmHg

Group	Value	95% CI
Family Check Up Control	8.3	± 12.2
Family Check-Up Heart	8.8	± 11.7

Blood Pressure at 6 Months Post-partum Secondary · 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.

Systolic mmHg

Group	Value	95% CI
Family Check Up Control	117.4	± 15.4
Family Check-Up Heart	119.1	± 12.5

Diastolic mmHg

Group	Value	95% CI
Family Check Up Control	78.5	± 11.4
Family Check-Up Heart	79.8	± 9.0

BMI at 6 Months Post-partum Secondary · 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.

Group	Value	95% CI
Family Check Up Control	32.7	± 12.5
Family Check-Up Heart	32.9	± 9.2

Change in Eating Behaviors Secondary · 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

Group	Value	95% CI
Family Check Up Control	-.50	± 4.1
Family Check-Up Heart	.39	± 3.8

Change in Physical Activity Secondary · 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 metabo

Group	Value	95% CI
Family Check Up Control	20.2	± 91.1
Family Check-Up Heart	27.8	± 75.8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.