Women's Healthy Aging and Menopause; (WHAM)

NCT ID: NCT07314827

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-01-31

Brief Summary

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.

Conditions

Meditation; Health Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcendental Meditation (TM)

Intervention Type: 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)

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.

Group Type: ACTIVE_COMPARATOR

Women's Health Education (WHE)

Intervention Type: 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.

Interventions

Transcendental Meditation (TM)

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).

Intervention Type: BEHAVIORAL

Women's Health Education (WHE)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. ≥130 systolic blood pressure (SBP) ≤160 and/or 84 ≥ diastolic blood pressure (DBP) ≤100.

2. Perceived stress scale (PSS-4) > 5

3. Able to give informed consent.

4. Understand study procedures and comply with them for the length of the study.

5. Ages between 50 and 80 years.

6. Post-menopausal ≥ 1 year since last menstruation

7. Reads and speaks English

8. UHealth patients

9. Working at least part-time

Exclusion Criteria

1. Currently in a meditation program.

2. Meditates more than once per week

3. Recent stroke or cerebral neurologic impairment.

4. Current uses of mood stabilizers or antipsychotics.

5. Has been diagnosed with bipolar disorder, schizophrenia, or substance use disorder.

6. Inability to give written informed consent in English.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

E. Robert Schwartz

Professor and Chair Emeritus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward R Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Central Contacts

Laura Redwine, PhD

Role: CONTACT

lss61@miami.edu

305-243-5267

Jacqueline Allen-Magers, MS

Role: CONTACT

jacqueline.am@miu.edu

Other Identifiers

20250622

Identifier Type: -

Identifier Source: org_study_id