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The Impact of a Race-Based Stress Reduction Intervention

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Site contact updatedv7
  3. Site contact updatedv6
  4. Start date: Oct 23, 2023 to Oct 18, 2023v5
  5. Start date: Mar 10, 2023 to Oct 23, 2023
    • Primary completion date: Mar 2028 to Jan 31, 2028
    • Study completion date: Mar 2029 to Jan 31, 2028
    v4
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  1. Primary endpoints: 11 to 1
    • Eligibility criteria revised
    • Secondary endpoints: 5 to 15
    v3
  2. Secondary endpoints: details revised at 4 of 5 entriesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to learn whether a stress reduction program called Resilience, Stress, and Ethnicity (RiSE) improves well-being, inflammation, and the epigenome in African American (AA) women who have risk factors for heart or metabolic disease. The main question it aims to answer is whether an intervention that integrates cognitive-behavioral strategies focused on the impact that social stress, such as racism, has on the body, racial identity development, and empowerment. Participants will placed in one of the two following groups: * The RiSE program will focus on teaching participants how to reduce their stress levels and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks. * The Health Education program will include education on how to improve general health and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks. Participants will provide saliva to measure cytokines and DNA methylation (DNAm), complete questionnaires, and have blood pressure, heart rate, and weight measured at the following clinic visits: 1. Prior to starting the intervention 2. Mid-way through the intervention (Week 4) 3. End of the intervention (Week 8) 4. Six (6) months after the completion of the intervention
Trial Details
NCT Number NCT05902741
Lead Sponsor Loyola University
Collaborators: Columbia University
Conditions
(from sponsor)		 Racism, Stress, Inflammation
Related terms Inflammation, Racism
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov