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

NCT05499507 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2025-12-11

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

COH

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).

BEHAVIORAL

COH+

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

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Temple University

    lead OTHER

Principal Investigators

  • Sharon J Herring, MD, MPH · Temple University, Philadelphia, Pennsylvania, United States, 19140

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-24
Primary Completion
2027-07-15
Completion
2028-12-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05499507 on ClinicalTrials.gov