Women's Healthy Aging and Menopause; (WHAM)

NCT07314827 | Not Yet Recruiting

• 1 other identifier: 20250622
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (11)

• Recruitment feasibility-The number of individuals approached vs participate.

  Recruiters will record the numbers of individuals who agree to participate vs interested in hearing about the study.

  up to 3 years

• Recruitment feasibility-Reasons for not participating

  A checklist completed by recruiters (schedule, time commitment, topic, ineligible, other)

  up to 3 years

• Attendance feasibility - Training sessions attended by TM and WHE group

  Training sessions attended by the TM participants as well as the attendance and participation in videos watched for the WHE group will be recorded.

  12 weeks

• Compliance feasibility - The number of meditation sessions per week for the TM participants.

  Participants in the TM group estimate in the last month how many days per week they meditated (0 = not at all, 1 = up to 3 days per week, 2 = nearly every day once per day, 3 = nearly every day twice per day)

  12 and 24 weeks

• Stress - Perceived Stress Scale-10 (PSS-10)

  Validated self-reporting instrument with 10 questions on perceived stress. Each question is rated on a 5-point Likert scale ranging from 0 = never to 4 = Very Often, referring to experiences in the past month. Total scores range from 0 to 40, higher = more stress.

  Baseline, 8, 12, and 24 weeks

• Depressed mood - Patient Health Questionnaire-9, (PHQ-9)

  A 9-item self-report measure of depressive symptoms. Each question is rated on a scale of 0 to 3, based on how often the symptom has been experienced in the past two weeks (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). The total score ranges from 0 to 27, higher scores indicating more severe depression.

  Baseline, 8, 12, and 24 weeks

• Anxiety - Generalized Anxiety Disorder-7, (GAD-7)

  A 7-item self-report questionnaire assessing symptoms of generalized anxiety disorder. Items are rated on a scale of 0-3 based on frequency over the past two weeks (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). The total score ranges from 0-21, with higher scores indicating more severe anxiety symptoms.

  Baseline, 8, 12, and 24 weeks

• Pain - Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Pain Intensity

  Patient-reported outcomes from the PROMIS system. Pain Interference items assess the extent to which pain hampers daily activities, social, and emotional functioning. Pain Intensity is assessed with a 0-10 numeric rating scale for worst, average, and current pain. Higher scores indicate greater pain burden.

  Baseline, 8, 12, and 24 weeks

• Menopausal Symptoms - Greene Climacteric Scale (GCS)

  A 21-item questionnaire assessing menopausal symptoms across four domains: psychological (anxiety/depression), somatic (aches, headaches), vasomotor (hot flashes, night sweats), and sexual function. Each item is scored 0-3 (0 = Not at all, 3 = Extremely). Total and subscale scores indicate severity of menopausal symptoms.

  Baseline, 8, 12, and 24 weeks

• Fruits and Vegetables Intake

  A brief dietary assessment asking participants to report the average number of daily servings of fruits and vegetables consumed. Responses are recorded as number of servings per day.

  Baseline, 8, 12, and 24 weeks

• 24-hour Hemodynamic Monitoring

  Continuous ambulatory monitoring using Bio-Beat patches and a Polar chest strap. Measures include systolic and diastolic blood pressure, and heart rate averaged over 24 hours. Provides objective cardiovascular data.

  Baseline and 12 weeks

Secondary Outcomes (8)

• Acceptability quantitative - Satisfaction with interventions

  12-weeks post interventions

• Acceptability qualitative - Strengths and weaknesses of the interventions

  12-weeks post intervention

• Mental Well-being - Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

  Baseline, 8, 12, and 24 weeks

• Insomnia - Insomnia Severity Index (ISI)

  Baseline, 8, 12, and 24 weeks

• Primary Care Probable Post-Traumatic Stress Disorder (PTSD) Screen for Diagnostic and Statistical Manual for Mental Disorders (DSM-5) (PC-PTSD-5)

  Baseline, 8, 12, and 24 weeks

Study Arms (2)

Transcendental Meditation (TM)

EXPERIMENTAL

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.

Behavioral: Transcendental Meditation (TM)

Women's Health Education (WHE)

ACTIVE COMPARATOR

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.

Behavioral: Women's Health Education (WHE)

Interventions

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.

Women's Health Education (WHE)

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).

Transcendental Meditation (TM)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: This study will only enroll only female participants because we are looking at the relationship between menopause and blood pressure.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥130 systolic blood pressure (SBP) ≤160 and/or 84 ≥ diastolic blood pressure (DBP) ≤100.
• Perceived stress scale (PSS-4) \> 5
• Able to give informed consent.
• Understand study procedures and comply with them for the length of the study.
• Ages between 50 and 80 years.
• Post-menopausal ≥ 1 year since last menstruation
• Reads and speaks English
• UHealth patients
• Working at least part-time

You may not qualify if:

• Currently in a meditation program.
• Meditates more than once per week
• Recent stroke or cerebral neurologic impairment.
• Current uses of mood stabilizers or antipsychotics.
• Has been diagnosed with bipolar disorder, schizophrenia, or substance use disorder.
• Inability to give written informed consent in English.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Health Education

Interventions

Meditation

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Edward R Schwartz, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Redwine, PhD

CONTACT

305-243-5267; lss61@miami.edu

Jacqueline Allen-Magers, MS

CONTACT

jacqueline.am@miu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Emeritus

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)