RecruitingNot ApplicableNCT05499507

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

Sponsor

Temple University

Enrollment

432 participants

Start Date

Jan 24, 2023

Study Type

INTERVENTIONAL

Conditions

Obesity Hypertension Pregnancy Related Racism

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (Change of HEART) is comparing two different approaches to reducing heart disease risk in Black women who are pregnant. Heart disease risk during and after pregnancy is significantly higher in Black women, and this study aims to find the most effective support strategy. **You may be eligible if...** - You identify as Black or African American - You are 18 or older and pregnant (less than 24 weeks along) - You have a BMI of 30 or above, or have been diagnosed with high blood pressure (130/80 or higher on two readings) - You own a smartphone **You may NOT be eligible if...** - You do not meet the blood pressure or BMI criteria - You are more than 24 weeks pregnant at enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCOH

Incorporates two, evidence-based individual-level interventions (home blood pressure telemonitoring coupled with the interactive obesity treatment approach, that includes nutrition and physical activity text messages with tailored feedback) and an institutional-level intervention (anti-racism training of providers and staff along with patient feedback to inform respectful care).

BEHAVIORALCOH+

Includes all components of COH plus interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support).