Women's Healthy Aging and Menopause; (WHAM)

University of Miami

Status: Not yet enrolling

Conditions: Meditation; Health Education

Treatments: Behavioral: Women's Health Education (WHE); Behavioral: Transcendental Meditation (TM)

Study type: Interventional

Funder types: Other

Identifiers

NCT07314827

20250622

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Transcendental Meditation (TM)

Experimental group

Description:

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.

Treatment:

Behavioral: Transcendental Meditation (TM)

Women's Health Education (WHE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Women's Health Education (WHE)