Women's Healthy Aging and Menopause; (WHAM)

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07314827
Status
Not Yet Recruiting

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Conditions

  • Health Education
  • Meditation

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Transcendental Meditation (TM) — BEHAVIORAL
    Orientation: 18-minute self-guided video; 30-45 minute remote group introductory talk. Instructional phase: 10-minute individual interview (phone/Zoom); one 60-75 minute in-person 1:1 TM instruction session at Miami TM Center, Lennar Center, or University of Miami (UM) Osher Center; three consecutive in-person group sessions (60-75 minutes each). Follow-up seminars: Six sessions over nine weeks (in person or Zoom), including a "10th Day Check" and additional \~30-minute seminars at 1, 2, and 3 months. Home practice: Two daily TM sessions (20 minutes each, morning and evening).
  • Women's Health Education (WHE) — BEHAVIORAL
    Stage 1: 30-minute video and introductory lecture on menopause and cardiovascular health. Stage 2: 60-minute one-on-one health coach meeting plus nutrition video. Stage 3: Eight sessions (\~30 minutes each) with health check-ins, materials, and videos covering physical activity for heart and bone health, sleep and stress management during menopause, and lifestyle goal review and planning.

Study Details

The present study will examine whether women at high risk for developing hypertension, i.e., post-menopausal status, at least mild psychological distress, and mildly elevated blood pressure, show improvements in these risk factors after a 12-week Transcendental Meditation (TM) intervention compared to Women's Health Education (WHE). Positive findings will provide initial evidence of using nonpharmacological methods, such as TM, to prevent hypertension in postmenopausal women.

Key Dates

Start date
Feb 1, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Transcendental Meditation (TM)
    Participants receive a standardized Transcendental Meditation (TM) program delivered over 12 weeks by a certified instructor, including orientation, structured instruction, follow-up seminars, and daily home practice.
  • Active Comparator: Women's Health Education (WHE)
    Participants receive a structured health education program over 12 weeks focused on menopause and cardiovascular health, delivered via Zoom and WhatsApp using evidence-based materials.

Primary Outcome Measure

Recruitment feasibility-The number of individuals approached vs participate. [ Time Frame: up to 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

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By research site
University of Miami· Miami, FL

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