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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-partum
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am pregnant or have given birth in the last 2 months and am involved with Magee or the WIC program in Allegheny County.
Select...
I do not have chronic kidney or liver disease, lupus, cancer, or HIV.
Select...
My child's legal guardian speaks English.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-partum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-partum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in postpartum weight retention
Secondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,720 Previous Clinical Trials
16,342,661 Total Patients Enrolled
31 Trials studying Hypertension
49,127 Patients Enrolled for Hypertension
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,898 Total Patients Enrolled
469 Trials studying Hypertension
2,692,482 Patients Enrolled for Hypertension
Janet M Catov, PhDPrincipal InvestigatorUPMC Magee Womens Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant with more than one baby.My child is 0-2 months old and we live in Allegheny County. I am participating in the study.I do not have chronic kidney or liver disease, lupus, cancer, or HIV.I am pregnant and have a chronic condition like kidney or liver disease, lupus, cancer, or HIV.I am pregnant or have given birth in the last 2 months and am involved with Magee or the WIC program in Allegheny County.My child's legal guardian speaks English.
Research Study Groups:
This trial has the following groups:- Group 1: Family Check Up Control
- Group 2: Family Check-Up Heart
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the uppermost capacity for participant enrollment in this investigation?
"Affirmative. According to records on clinicaltrials.gov, this ongoing trial was initially posted on the 18th of November 2022 and most recently amended a few weeks later. 150 participants are needed at 2 medical sites."
Answered by AI
Is this research project still recruiting participants?
"Data on clinicaltrials.gov confirms that this medical trial is still searching for participants, with its initial posting going up the 18th of November 2022 and the most recent changes made 28 days later."
Answered by AI
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