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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 20% 432 → 345 participants
See other at-risk trials from Temple University

Record History

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  1. Enrollment closed, study ongoingv6 Show 5 more changesShow less
    • Enrollment reduced: 432 → 345 participants
    • Study completion pushed from Dec 10, 2028 to Jan 9, 2029
    • Eligibility criteria revised
    • Site details revised
    • Study description shortened, about 1 word
  2. Primary completion date: Jul 10, 2026 to Jul 15, 2027
    • Study completion date: Oct 10, 2026 to Dec 10, 2028
    • Secondary endpoints: 26 to 23
    • Site contact updated
    v5
  3. Site contact updatedv4
  4. Start date changed from estimate of Jan 19, 2023 to Jan 24, 2023v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 1, 2022 to Jan 19, 2023
    • Study sites: 0 to 1
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Temple University
44 trials monitored
See 2 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
Hypertension
1,925 trials monitored
See 99 trials at risk
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.
Trial Details
NCT Number NCT05499507
Lead Sponsor Temple University
Collaborators: Patient-Centered Outcomes Research Institute
Conditions
(from sponsor)		 Pregnancy Related, Hypertension, Obesity, Racism
Related terms Hypertension, Obesity, Racism
Enrollment 345 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov