Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT05499507

The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)

Led by Temple University · Updated on 2025-12-11

432

Participants Needed

1

Research Sites

306 weeks

Total Duration

On this page

Sponsors

T

Temple University

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

The overarching goal of our proposal is to reduce disparities in perinatal cardiovascular disease risk factors among Black women utilizing a community-driven, social ecological framework.

CONDITIONS

Official Title

The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Baseline body mass index (BMI) of 30 kg/m2 or higher and/or diagnosis of high blood pressure (130/80 or higher on two occasions)
  • Pregnant and less than 24 weeks gestation by last menstrual period
  • Owns a smartphone
  • Self-identifies as Black or African American
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Temple University/Temple Health

Philadelphia, Pennsylvania, United States, 19140

Actively Recruiting

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Research Team

S

Sharon J Herring, MD, MPH

CONTACT

C

Christine Santoro, CPM, MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART) | DecenTrialz