Family Check-Up Heart for Hypertension, Pregnancy-Induced

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Magee Womens Hospital, Pittsburgh, PA
Hypertension, Pregnancy-Induced+5 More
Family Check Up Heart - Behavioral
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hypertension, Pregnancy-Induced

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 6 months post-partum

6 months post-partum
Weight at 6 months postpartum
Month 6
BMI at 6 months post-partum
Blood pressure at 6 months post-partum
Change in blood pressure from first prenatal visit to 6 months
Change in blood pressure from post-delivery to 6 months
Change in eating behaviors
Change in physical activity
Change in postpartum weight retention
Change in self-reported pre-pregnancy weight to 6 months postpartum
Weight change from first measured prenatal weight to 6 months postpartum

Trial Safety

Safety Progress

1 of 3

Other trials for Hypertension, Pregnancy-Induced

Trial Design

2 Treatment Groups

Family Check Up Control
1 of 2
Family Check-Up Heart
1 of 2
Active Control
Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Family Check-Up Heart · No Placebo Group · N/A

Family Check-Up Heart
Behavioral
Experimental Group · 1 Intervention: Family Check Up Heart · Intervention Types: Behavioral
Family Check Up Control
Behavioral
ActiveComparator Group · 1 Intervention: Family Check-Up · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months post-partum

Trial Background

Prof. Janet Catov, Associate Professor
Principal Investigator
University of Pittsburgh
Closest Location: Magee Womens Hospital · Pittsburgh, PA
Photo of Pittsburgh  1Photo of Pittsburgh  2Photo of Pittsburgh  3
2007First Recorded Clinical Trial
1 TrialsResearching Hypertension, Pregnancy-Induced
20 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are pregnant or 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.
A woman is eligible for the trial if she is aged 18 years or older, has a cardiovascular risk factor identified during pregnancy, and has a pre-pregnancy body mass index (BMI) of 25 kg/m2 or greater.
You are fluent in English.
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.
Children born through 2 months who reside in Allegheny County may enroll in the program if their mother is participating in the study.
You have a legal guardian who speaks English or Spanish or has an interpreter for other languages

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.