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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05473767

Enrollment

117

Registered

2022-07-26

Start date

2022-11-18

Completion date

2024-11-22

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension in Pregnancy, Hypertension, Pregnancy-Induced, Obesity, Maternal, Overweight

Keywords

Cardiovascular health, Postpartum women, Health Promotion

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.

Interventions

BEHAVIORALFamily 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.

BEHAVIORALFamily 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

Investigators will be blind to group assignment during intervention delivery and assessment.

Intervention 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.

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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. Mean difference scores are reported.

Secondary

Measure	Time frame	Description
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. Mean difference scores are reported.
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. Mean difference scores are reported.
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. Mean difference scores are reported.
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. Mean difference scores are reported.
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.
BMI at 6 Months Post-partum	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.
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. Mean difference scores are reported.
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. Mean difference scores are reported.
Blood Pressure at 6 Months Post-partum	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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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.	23
Family Check-Up Heart Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.	71
Total	94

Baseline characteristics

Characteristic	Total	Family Check-Up Heart	Family Check Up Control
Age, Continuous	29.4 Year STANDARD_DEVIATION 5.64	29.7 Year STANDARD_DEVIATION 5.2	28.3 Year STANDARD_DEVIATION 6.85
Blood pressure (Diastolic) at 4 weeks postpartum assessed using validated Bluetooth devices	82.20 Diastolic mmHg STANDARD_DEVIATION 11.97	83.79 Diastolic mmHg STANDARD_DEVIATION 12.21	77.84 Diastolic mmHg STANDARD_DEVIATION 10.38
Blood pressure (Systolic) at 4 weeks postpartum assessed using validated Bluetooth devices	119.35 Systolic mmHg STANDARD_DEVIATION 15.45	120.92 Systolic mmHg STANDARD_DEVIATION 14.3	115.05 Systolic mmHg STANDARD_DEVIATION 17.97
BMI at 4 weeks postpartum	31.83 kg/m^2 STANDARD_DEVIATION 10.1	32.73 kg/m^2 STANDARD_DEVIATION 8.97	29.5 kg/m^2 STANDARD_DEVIATION 12.46
Pregnancy Physical Activity Questionnaire (PPAQ)	98.52 Score (0-308.85) STANDARD_DEVIATION 61.19	101.55 Score (0-308.85) STANDARD_DEVIATION 59.72	89.45 Score (0-308.85) STANDARD_DEVIATION 65.91
Pre-pregnancy weight	196.6 Pounds STANDARD_DEVIATION 61	200.6 Pounds STANDARD_DEVIATION 60.5	181.7 Pounds STANDARD_DEVIATION 63.5
Race (NIH/OMB) American Indian or Alaska Native	4 Participants	2 Participants	2 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	52 Participants	39 Participants	13 Participants
Race (NIH/OMB) More than one race	9 Participants	8 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	29 Participants	22 Participants	7 Participants
Rapid Eating Assessment for Participants (REAP) - Shortened Version	27.10 Score (13-39) STANDARD_DEVIATION 3.54	26.9 Score (13-39) STANDARD_DEVIATION 3.59	27.43 Score (13-39) STANDARD_DEVIATION 3.46
Sex: Female, Male Female	94 Participants	71 Participants	23 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants
Weight at 4 weeks postpartum	196.76 Pounds STANDARD_DEVIATION 58.27	200.53 Pounds STANDARD_DEVIATION 56.3	186.43 Pounds STANDARD_DEVIATION 63.79

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 87
other Total, other adverse events	0 / 30	0 / 87
serious Total, serious adverse events	0 / 30	0 / 87

Outcome results

Primary

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.

Time frame: Baseline to 6 months post-partum