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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Check Up Heart
Family Check-Up
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Maternal focused on measuring Cardiovascular health, Postpartum women, Health Promotion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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 will 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.

Sites / Locations

  • Magee Womens HospitalRecruiting
  • Women, Infants, and Children Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Family Check Up Control

Family Check-Up Heart

Arm Description

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 combines the traditional Family Check-Up with a heart health component.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Weight at 6 months postpartum
Weight at 6 months 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
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 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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 19, 2022
Last Updated
November 28, 2022
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05473767
Brief Title
Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children
Official Title
Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children (ENRICH)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Maternal, Hypertension in Pregnancy, Hypertension, Pregnancy-Induced, Diabetes, Overweight
Keywords
Cardiovascular health, Postpartum women, Health Promotion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
Investigators will be blind to group assignment during intervention delivery and assessment.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Family Check Up Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Family Check-Up Heart
Arm Type
Experimental
Arm Description
Family Check-Up Heart combines the traditional Family Check-Up with a heart health component.
Intervention Type
Behavioral
Intervention Name(s)
Family Check Up Heart
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family Check-Up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in postpartum weight retention
Description
Weight change from post-delivery to 6 months; both will be measured by the study using validated Bluetooth devices and following standardized research protocols.
Time Frame
Baseline to 6 months post-partum
Secondary Outcome Measure Information:
Title
Weight at 6 months postpartum
Description
Weight at 6 months will be assessed by the study using validated Bluetooth devices and following standardized research protocols.
Time Frame
6 months post-partum
Title
Weight change from first measured prenatal weight to 6 months postpartum
Description
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.
Time Frame
Baseline to 6 months post-partum
Title
Change in self-reported pre-pregnancy weight to 6 months postpartum
Description
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.
Time Frame
Baseline to 6 months post-partum
Title
Change in blood pressure from post-delivery to 6 months
Description
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.
Time Frame
Baseline to 6 months post-partum
Title
Change in blood pressure from first prenatal visit to 6 months
Description
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.
Time Frame
Baseline to 6 months post-partum
Title
Blood pressure at 6 months post-partum
Description
Blood pressure at 6 months post-partum will be assessed by the study using validated Bluetooth devices and following standardized research protocols.
Time Frame
Baseline to 6 months post-partum
Title
BMI at 6 months post-partum
Description
Height and Weight at 6 months post-partum will be assessed by the study using a validated Bluetooth scale and following standardized research protocols.
Time Frame
Baseline to 6 months post-partum
Title
Change in eating behaviors
Description
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.
Time Frame
Baseline to 6 months post-partum
Title
Change in physical activity
Description
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.
Time Frame
Baseline to 6 months post-partum

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Participants who consent to enrollment will 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. Exclusion Criteria: Pregnant women with complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV. Multifetal pregnancies or deliveries.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet M Catov, PhD
Organizational Affiliation
UPMC Magee Womens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Catov, PhD
Phone
412-641-6217
Email
catovjm@upmc.edu
First Name & Middle Initial & Last Name & Degree
Alisse Hauspurg, MD
Phone
412-641-1381
Email
janickia@upmc.edu
First Name & Middle Initial & Last Name & Degree
Janet Catov, PhD
Facility Name
Women, Infants, and Children Program
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15222
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Matt, MS RD
Phone
412-350-5804
Email
lisa.matt@alleghenycounty.us

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
We will share data within two years of the end of our funding to allow time for analysis and dissemination of findings.
IPD Sharing Access Criteria
Interested investigators seek written approval from the study Principle Investigators. An Institutional Review Board protocol approved by their institution or a signed data sharing agreement is needed to access the data.
Citations:
PubMed Identifier
15510530
Citation
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.
Results Reference
background
PubMed Identifier
15595297
Citation
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. Erratum In: Med Sci Sports Exerc. 2011 Jan;43(1):195.
Results Reference
background

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

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