Women's Healthy Aging and Menopause; (WHAM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-80
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥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.
Disqualifiers
Currently in a meditation program.
Meditates more than once per week
Recent stroke or cerebral neurologic impairment.
Current uses of mood stabilizers or antipsychotics.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcendental Meditation (TM)
BehavioralOrientation: 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)
BehavioralStage 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Transcendental Meditation (TM)Experimental treatment 1 intervention
Group B: Women's Health Education (WHE)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 3 years2
Recruitment feasibility-Reasons for not participating
A checklist completed by recruiters (schedule, time commitment, topic, ineligible, other)
Time frame
up to 3 years3
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.
Time frame
12 weeks4
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)
Time frame
12 and 24 weeksSecondary outcomes
1
Acceptability quantitative - Satisfaction with interventions
Satisfaction with interventions Likert Scale (0-4, with 0 as not at all satisfied and 4 as extremely satisfied).
Time frame
12-weeks post interventions2
Acceptability qualitative - Strengths and weaknesses of the interventions
Participants will be asked to write one to two sentences on the strengths and one to two sentences on the weaknesses of the intervention e.g., time commitment, travel to sites (TM group)
Time frame
12-weeks post intervention3
Mental Well-being - Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
A 14-item self-report scale assessing positive mental health and well-being. Each item is rated on a 5-point Likert scale from 1 = None of the time to 5 = All of the time, based on experiences over the past two weeks. Total scores range from 14-70, with higher scores reflecting greater well-being.
Time frame
Baseline, 8, 12, and 24 weeks4
Insomnia - Insomnia Severity Index (ISI)
A 7-item self-report measure assessing the nature, severity, and impact of insomnia. Each item is scored on a 0-4 scale (0 = No problem, 4 = Very severe problem) based on the previous two weeks. Total scores range from 0-28, with higher scores indicating more severe insomnia symptoms.
Time frame
Baseline, 8, 12, and 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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