Clinical trial NCT05473767: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Maternal
Hypertension in Pregnancy
Hypertension, Pregnancy-Induced
Diabetes
Overweight
Keywords: Cardiovascular health
Postpartum women
Health Promotion
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-07-26
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in postpartum weight retention
timeFrame: Baseline to 6 months post-partum
Secondary outcomes:
measure: Weight at 6 months postpartum
timeFrame: 6 months post-partum
measure: Weight change from first measured prenatal weight to 6 months postpartum
timeFrame: Baseline to 6 months post-partum
measure: Change in self-reported pre-pregnancy weight to 6 months postpartum
timeFrame: Baseline to 6 months post-partum
measure: Change in blood pressure from post-delivery to 6 months
timeFrame: Baseline to 6 months post-partum
measure: Change in blood pressure from first prenatal visit to 6 months
timeFrame: Baseline to 6 months post-partum
measure: Blood pressure at 6 months post-partum
timeFrame: Baseline to 6 months post-partum
measure: BMI at 6 months post-partum
timeFrame: Baseline to 6 months post-partum
measure: Change in eating behaviors
timeFrame: Baseline to 6 months post-partum
measure: Change in physical activity
timeFrame: Baseline to 6 months post-partum
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Healthy Start, Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Womens Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Women, Infants, and Children Program
state: Pennsylvania
Study officials:
affiliation: UPMC Magee Womens Hospital
name: Janet M Catov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.