Trial Outcomes & Findings for Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children (NCT NCT05473767)
NCT ID: NCT05473767
Last Updated: 2026-01-12
Results Overview
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.
COMPLETED
NA
117 participants
Baseline to 6 months post-partum
2026-01-12
Participant Flow
In person and remote recruitment at several locations serving pregnant women and mothers with newborns including a large birthing hospital and WIC clinics. Eligibility criteria: (1) Single pregnancy or biological mother of child \< 2 months old, (2) Allegheny County, PA residency, (3) Medicaid or WIC receipt, (4) English fluency, (5) is/will be main caretaker of the baby in their home, and (6) no complex medical conditions. Participants were randomized 2:1 to the intervention after consent.
Participant milestones
| Measure |
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.
|
Family Check-Up Heart
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
87
|
|
Overall Study
COMPLETED
|
15
|
54
|
|
Overall Study
NOT COMPLETED
|
15
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fewer participants were assessed for in person weight measurements.
Baseline characteristics by cohort
| Measure |
Family Check Up Control
n=23 Participants
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.
|
Family Check-Up Heart
n=71 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.3 Year
STANDARD_DEVIATION 6.85 • n=23 Participants
|
29.7 Year
STANDARD_DEVIATION 5.20 • n=71 Participants
|
29.4 Year
STANDARD_DEVIATION 5.64 • n=94 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=23 Participants
|
71 Participants
n=71 Participants
|
94 Participants
n=94 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=23 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=23 Participants
|
2 Participants
n=71 Participants
|
4 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=23 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=23 Participants
|
39 Participants
n=71 Participants
|
52 Participants
n=94 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=23 Participants
|
22 Participants
n=71 Participants
|
29 Participants
n=94 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=23 Participants
|
8 Participants
n=71 Participants
|
9 Participants
n=94 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=94 Participants
|
|
Weight at 4 weeks postpartum
|
186.43 Pounds
STANDARD_DEVIATION 63.79 • n=20 Participants • Fewer participants were assessed for in person weight measurements.
|
200.53 Pounds
STANDARD_DEVIATION 56.30 • n=52 Participants • Fewer participants were assessed for in person weight measurements.
|
196.76 Pounds
STANDARD_DEVIATION 58.27 • n=72 Participants • Fewer participants were assessed for in person weight measurements.
|
|
Pre-pregnancy weight
|
181.7 Pounds
STANDARD_DEVIATION 63.5 • n=20 Participants • Fewer participants were assessed for the staff-led interview.
|
200.6 Pounds
STANDARD_DEVIATION 60.5 • n=59 Participants • Fewer participants were assessed for the staff-led interview.
|
196.6 Pounds
STANDARD_DEVIATION 61.0 • n=79 Participants • Fewer participants were assessed for the staff-led interview.
|
|
Blood pressure (Systolic) at 4 weeks postpartum assessed using validated Bluetooth devices
|
115.05 Systolic mmHg
STANDARD_DEVIATION 17.97 • n=19 Participants • Fewer participants were assessed for in person blood pressure measurements.
|
120.92 Systolic mmHg
STANDARD_DEVIATION 14.30 • n=52 Participants • Fewer participants were assessed for in person blood pressure measurements.
|
119.35 Systolic mmHg
STANDARD_DEVIATION 15.45 • n=71 Participants • Fewer participants were assessed for in person blood pressure measurements.
|
|
Blood pressure (Diastolic) at 4 weeks postpartum assessed using validated Bluetooth devices
|
77.84 Diastolic mmHg
STANDARD_DEVIATION 10.38 • n=19 Participants • Fewer participants were assessed for in person blood pressure measurements.
|
83.79 Diastolic mmHg
STANDARD_DEVIATION 12.21 • n=52 Participants • Fewer participants were assessed for in person blood pressure measurements.
|
82.20 Diastolic mmHg
STANDARD_DEVIATION 11.97 • n=71 Participants • Fewer participants were assessed for in person blood pressure measurements.
|
|
BMI at 4 weeks postpartum
|
29.5 kg/m^2
STANDARD_DEVIATION 12.46 • n=20 Participants • Fewer participants were assessed for in person weight measurements.
|
32.73 kg/m^2
STANDARD_DEVIATION 8.97 • n=52 Participants • Fewer participants were assessed for in person weight measurements.
|
31.83 kg/m^2
STANDARD_DEVIATION 10.10 • n=72 Participants • Fewer participants were assessed for in person weight measurements.
|
|
Rapid Eating Assessment for Participants (REAP) - Shortened Version
|
27.43 Score (13-39)
STANDARD_DEVIATION 3.46 • n=23 Participants • Two participants in the FCU Heart group did not complete the questionnaire.
|
26.9 Score (13-39)
STANDARD_DEVIATION 3.59 • n=69 Participants • Two participants in the FCU Heart group did not complete the questionnaire.
|
27.10 Score (13-39)
STANDARD_DEVIATION 3.54 • n=92 Participants • Two participants in the FCU Heart group did not complete the questionnaire.
|
|
Pregnancy Physical Activity Questionnaire (PPAQ)
|
89.45 Score (0-308.85)
STANDARD_DEVIATION 65.91 • n=23 Participants
|
101.55 Score (0-308.85)
STANDARD_DEVIATION 59.72 • n=71 Participants
|
98.52 Score (0-308.85)
STANDARD_DEVIATION 61.19 • n=94 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months post-partumPopulation: Participants who were retained for outcomes assessment were used in analyses.
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.
Outcome measures
| Measure |
Family Check-Up Heart
n=46 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Family Check Up Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Postpartum Weight Retention
|
.29 Pounds
Standard Deviation 14.1
|
-.73 Pounds
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 6 months post-partumPopulation: Participants who were retained for outcomes assessment were used in analyses.
Weight at 6 months will be assessed by the study using validated Bluetooth devices and following standardized research protocols.
Outcome measures
| Measure |
Family Check-Up Heart
n=46 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Family Check Up Control
n=13 Participants
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.
|
|---|---|---|
|
Weight at 6 Months Postpartum
|
202.1 Pounds
Standard Deviation 58.3
|
200.2 Pounds
Standard Deviation 70.9
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-partumPopulation: Participants who were retained for outcomes assessment were used in analyses.
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.
Outcome measures
| Measure |
Family Check-Up Heart
n=46 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Family Check Up Control
n=13 Participants
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.
|
|---|---|---|
|
Weight Change From First Measured Prenatal Weight to 6 Months Postpartum
|
1.98 Pounds
Standard Deviation 18.9
|
11.5 Pounds
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-partumPopulation: Participants who were retained for outcomes assessment were used in analyses.
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.
Outcome measures
| Measure |
Family Check-Up Heart
n=46 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Family Check Up Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Self-reported Pre-pregnancy Weight to 6 Months Postpartum
|
4.7 Pounds
Standard Deviation 24.2
|
13.1 Pounds
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-partumPopulation: Participants who were retained for outcomes assessment were used in analyses.
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.
Outcome measures
| Measure |
Family Check-Up Heart
n=46 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Family Check Up Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Blood Pressure From Post-delivery to 6 Months.
Systolic mmHg
|
-1.4 mmHg
Standard Deviation 13.5
|
-1.76 mmHg
Standard Deviation 7.4
|
|
Change in Blood Pressure From Post-delivery to 6 Months.
Diastolic mmHg
|
-3.59 mmHg
Standard Deviation 13.2
|
-1.38 mmHg
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-partumPopulation: Participants who were retained for outcomes assessment were used in analyses.
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.
Outcome measures
| Measure |
Family Check-Up Heart
n=46 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Family Check Up Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Blood Pressure From First Prenatal Visit to 6 Months.
Systolic mmHg
|
-.20 mmHg
Standard Deviation 14.4
|
-6.3 mmHg
Standard Deviation 12.8
|
|
Change in Blood Pressure From First Prenatal Visit to 6 Months.
Diastolic mmHg
|
8.8 mmHg
Standard Deviation 11.7
|
8.3 mmHg
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 6 months post-partumPopulation: Participants who were retained for outcomes assessment were used in analyses.
Blood pressure at 6 months post-partum will be assessed by the study using validated Bluetooth devices and following standardized research protocols.
Outcome measures
| Measure |
Family Check-Up Heart
n=46 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Family Check Up Control
n=13 Participants
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.
|
|---|---|---|
|
Blood Pressure at 6 Months Post-partum
Systolic mmHg
|
119.1 mmHg
Standard Deviation 12.5
|
117.4 mmHg
Standard Deviation 15.4
|
|
Blood Pressure at 6 Months Post-partum
Diastolic mmHg
|
79.8 mmHg
Standard Deviation 9.0
|
78.5 mmHg
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 6 months post-partumPopulation: Participants who were retained for outcomes assessment were used in analyses.
Height and Weight at 6 months post-partum will be assessed by the study using a validated Bluetooth scale and following standardized research protocols.
Outcome measures
| Measure |
Family Check-Up Heart
n=46 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Family Check Up Control
n=13 Participants
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.
|
|---|---|---|
|
BMI at 6 Months Post-partum
|
32.9 kg/m²
Standard Deviation 9.2
|
32.7 kg/m²
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-partumPopulation: Participants who were retained for outcomes assessment were used in analyses.
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.
Outcome measures
| Measure |
Family Check-Up Heart
n=46 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Family Check Up Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Eating Behaviors
|
.39 Score
Standard Deviation 3.8
|
-.50 Score
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline to 6 months post-partumPopulation: Participants who were retained for outcomes assessment were used in analyses.
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.
Outcome measures
| Measure |
Family Check-Up Heart
n=46 Participants
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
|
Family Check Up Control
n=13 Participants
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.
|
|---|---|---|
|
Change in Physical Activity
|
27.8 Score
Standard Deviation 75.8
|
20.2 Score
Standard Deviation 91.1
|
Adverse Events
Family Check Up Control
Family Check-Up Heart
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place