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Family Check-Up Heart for Cardiovascular Health

N/A

Recruiting

Led By Janet M Catov, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults: 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

Adults: Does not have complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV

Must not have

Pregnant women with complex, on-going conditions such as chronic renal or liver disease, systemic lupus erythematosus, cancer or HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-partum

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a cardiovascular health intervention for postpartum mothers and infants. The intervention will be delivered through an evidence-based home visiting program, Family Check-Up. The study will test the feasibility and effectiveness of the intervention.

Who is the study for?

This trial is for postpartum mothers and infants in Allegheny County, PA. Eligible participants are Medicaid-eligible women who have recently given birth or are pregnant, speak English, and don't have complex conditions like chronic renal/liver disease or HIV. Infants can join if they're under 2 months old with a legal guardian who speaks English.

What is being tested?

The study tests the Family Check-Up Heart program against the standard Family Check-Up to improve cardiovascular health in new mothers. It's a pilot study where 100 will receive the heart-focused intervention and 50 will get regular check-ups to compare engagement and health outcomes.

What are the potential side effects?

Since this trial involves non-medical interventions focusing on cardiovascular health education and support, there may not be direct side effects as seen with medications; however, any potential discomfort from lifestyle changes will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am pregnant or have given birth in the last 2 months and am involved with Magee or the WIC program in Allegheny County.

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I do not have chronic kidney or liver disease, lupus, cancer, or HIV.

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My child's legal guardian speaks English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am pregnant and have a chronic condition like kidney or liver disease, lupus, cancer, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-partum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-partum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-partum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in postpartum weight retention

Secondary study objectives

BMI at 6 months post-partum

Blood pressure at 6 months post-partum

Change in blood pressure from first prenatal visit to 6 months

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Family Check-Up HeartExperimental Treatment1 Intervention

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

Group II: Family Check Up ControlActive Control1 Intervention

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.

0 / 4Eligibility criteria met