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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Temple University
Study ID
NCT05499507
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 24, 2023
Status verified
Dec 2025
Primary completion
Jul 15, 2027
Completion
Dec 10, 2028

Study Design

Enrollment
432 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Change of Heart (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).
  • Experimental: Change of Heart Plus (COH+)
    Includes all components of COH plus the addition of interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support).

Primary Outcome Measure

Change in blood pressure at 6-weeks postpartum. [ Time Frame: At baseline and 6-weeks postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Temple University/Temple HealthPhiladelphiaPennsylvania19140
Sharon J Herring, MD, MPH
[email protected]
215-707-2234

Find similar trials in Philadelphia, PA

By condition
Hypertension (high blood pressure)Obesity / overweight
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
Temple University/Temple Health· Philadelphia, PA

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