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Trial registered on ANZCTR
Registration number
ACTRN12625000134426
Ethics application status
Approved
Date submitted
17/01/2025
Date registered
6/02/2025
Date last updated
6/02/2025
Date data sharing statement initially provided
6/02/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of Transcendental Meditation (TM) on Mental and Cardiometabolic Health among staff at RMIT University, Australia: A Randomised Controlled Trial
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Scientific title
Effects of Transcendental Meditation (TM) on Mental and Cardiometabolic Health among staff at RMIT University, Australia: A Randomised Controlled Trial
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Secondary ID [1]
313565
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mental Health
336076
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Cardiometabolic Health
336077
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Condition category
Condition code
Metabolic and Endocrine
332628
332628
0
0
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Normal metabolism and endocrine development and function
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Cardiovascular
332624
332624
0
0
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Normal development and function of the cardiovascular system
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Mental Health
332627
332627
0
0
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Depression
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Public Health
332629
332629
0
0
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Health promotion/education
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Mental Health
332625
332625
0
0
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Studies of normal psychology, cognitive function and behaviour
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Mental Health
332626
332626
0
0
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Anxiety
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Mental Health
332631
332631
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This will be a two-arm, parallel-group randomised controlled trial.
Transcendental Meditation (TM) program includes a 5-day training provided by a trained TM teacher, with sessions lasting 1 hour/day for the first two days and 1.5 hours/day for the following three days.
Day one will be the introduction about the TM, this can be joined in-person or online.
Day two will be an in-person personal instruction, where teacher will select a personalised mantra (mental word) and teaches how to use it properly. Rest of the three days will be in-person individual or group (2-8) training depending upon the number of participants. These last four days of training will be in consecutive days. This training will be provided in quite room. The session attendance will be recorded.
Thereafter, follow-up discussions and check-in meetings (in-person or online in Teams) will be held fortnightly for 2 months and then monthly for the remaining 10 months. These check-in sessions will be in-person or online (Teams) and run for about an hour. Participants will be asked to meditate twice daily for 15-20 minutes at a time and place convenient for them. Meditation adherence will be recorded using a brief survey questionnaire (adapted) at two weeks interval for 12-month post-intervention.
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Intervention code [1]
330157
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Prevention
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Intervention code [2]
330155
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Behaviour
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Intervention code [3]
330156
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Lifestyle
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Comparator / control treatment
The control group will follow the lifestyle-as-usual (LAU) and continue the currently available wellbeing resources currently accessible to all staff at the university (e.g brisk walking, engaging in sports and fitness activities etc.). Special arrangements will not be made to encourage wellbeing activities. The control group will get the TM training at the end of the trial.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Perceived stress
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Assessment method [1]
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Perceived Stress Scale (PSS-10)
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Timepoint [1]
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Baseline, and 3-month, 6-month (primary end-point), and 12-month post-commencement of the intervention
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Secondary outcome [1]
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Sleep quality measured by smartwatch (Biostrap Kairos)
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Assessment method [1]
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Wearable smart device (Biostrap Kairos)
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Timepoint [1]
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [2]
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Insulin resistance (HOMA-IR)
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Assessment method [2]
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Insulin resistance measurement using HOMA-IR.
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Timepoint [2]
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Baseline and 6-month and 12-month post-commencement of the intervention
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Secondary outcome [3]
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Health-related quality of life (HRQoL)
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Assessment method [3]
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36-Item Short Form Survey Instrument (SF-36)
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Timepoint [3]
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [4]
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Anxiety symptoms
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Assessment method [4]
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Generalised anxiety disorder (GAD-7) scale
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Timepoint [4]
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [5]
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Body mass index (BMI)
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Assessment method [5]
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Anthropometric measurement: height using stadiometer, weight (Digital weighing machine: Withings bodyscan)
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Timepoint [5]
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [6]
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Emotion Regulation
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Assessment method [6]
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Emotion regulation questionnaire (ERQ-6)
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Timepoint [6]
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [7]
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Systolic and Diastolic Blood Pressure (SBP and DBP)
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Assessment method [7]
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Office BP measurement
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Timepoint [7]
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [8]
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Burnout
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Assessment method [8]
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Burnout assessment tool (BAT-23)
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Timepoint [8]
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [9]
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waist circumference
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Assessment method [9]
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Non elastic measuring tape
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Timepoint [9]
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Baseline, 3-month, 6-month, 12-month post-commencement of intervention
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Secondary outcome [10]
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Lipid profile
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Assessment method [10]
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Biochemical assessment of fasting blood sample
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Timepoint [10]
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Baseline and 6 month and 12-month post-commencement of intervention
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Secondary outcome [11]
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Antihypertensive drug or other drug use, if any
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Assessment method [11]
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Self-reported questionnaire (designed for this study)
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Timepoint [11]
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Baseline and 3-month, 6-month, and 12-month post-commencement of intervention
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Secondary outcome [12]
442930
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Depression symptoms
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Assessment method [12]
442930
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Center for Epidemiological Studies-Depression (CES-D, 10)
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Timepoint [12]
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [13]
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Work Productivity and Activity Impairment
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Assessment method [13]
442936
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Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH)
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Timepoint [13]
442936
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [14]
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Mental wellbeing
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Assessment method [14]
442933
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Warwick Edinburgh Mental Wellbeing Scale (WEMWBS-7), satisfaction with life- single item
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Timepoint [14]
442933
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [15]
442935
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Sleep Quality
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Assessment method [15]
442935
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Measured by PROMIS SD and SRI
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Timepoint [15]
442935
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [16]
442951
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Daily meditation practice (intervention group only)
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Assessment method [16]
442951
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Self-reported questionnaires (adapted)
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Timepoint [16]
442951
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At two weeks interval after completion of the TM training
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Secondary outcome [17]
442945
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Perceived benefit of meditation, barriers and facilitators. These outcomes will be assessed as a composite outcome.
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Assessment method [17]
442945
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In-depth interview among selected participants. The interview will be semi-structured, one-on-one interview (face-to-face or online in Teams) with a member of the research team.
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Timepoint [17]
442945
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At 6-month post-commencement of intervention
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Secondary outcome [18]
442947
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Alcohol, smoking use, and coffee use (composite)
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Assessment method [18]
442947
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Self-reported questionnaires adapted from WHO steps questionnaires
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Timepoint [18]
442947
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Baseline and 3-month, 6-month, and 12-month post-commencement of intervention
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Secondary outcome [19]
442939
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Heart Rate Variability (HRV)
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Assessment method [19]
442939
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Wearable smart device (Biostrap Kairos)
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Timepoint [19]
442939
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Baseline, and 3-month, 6-month, and 12-month post-commencement of the intervention
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Secondary outcome [20]
442944
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Salivary cortisol
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Assessment method [20]
442944
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By saliva sample (measured four times a day: 6-8 am, 12 pm, 4 pm and 8 pm)
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Timepoint [20]
442944
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Baseline and 6 month and 12-month post-commencement of intervention
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Secondary outcome [21]
442948
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Inflammatory markers
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Assessment method [21]
442948
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Such as high sensitivity C-reactive protein, interleukins (IL) IL-1beta, IL-6, IL-8, IL-10, tumor necrosis factor-alpha, and adipokines (such as adiponectin, resistin, adipsin) using biochemical assessment of fasting blood sample
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Timepoint [21]
442948
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Baseline and 6-month and 12-month post-commencement of intervention
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Secondary outcome [22]
442946
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Physical activity
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Assessment method [22]
442946
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Short form of physical activity (IPAQ)- single item
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Timepoint [22]
442946
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Baseline and 3-month, 6-month, and 12-month post-commencement of intervention
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Secondary outcome [23]
444318
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Fasting blood sugar
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Assessment method [23]
444318
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Biochemical assessment of fasting blood sample
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Timepoint [23]
444318
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Baseline and 6-month and 12-month post-commencement of the intervention
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Secondary outcome [24]
442949
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Telomere length
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Assessment method [24]
442949
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From peripheral blood mononuclear cells (PBMC)
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Timepoint [24]
442949
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Baseline and 6-month and 12-month post-commencement of intervention
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Secondary outcome [25]
444319
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Daily steps
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Assessment method [25]
444319
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Daily steps count measured by Biostrap Kairos smartwatch.
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Timepoint [25]
444319
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Baseline and 3-month, 6-month, and 12-month post-commencement of intervention
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Secondary outcome [26]
442950
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Number of sick leaves over the past month
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Assessment method [26]
442950
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Self-reported scales adapted for this study
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Timepoint [26]
442950
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Baseline, and at monthly interval post-commencement of the intervention
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Secondary outcome [27]
442952
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Training satisfaction questionnaire
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Assessment method [27]
442952
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Self-reported tool (adapted)
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Timepoint [27]
442952
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After meditation training
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Secondary outcome [28]
444315
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Sympathetic arousal
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Assessment method [28]
444315
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Wearable smart device (Biostrap Kairos)
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Timepoint [28]
444315
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Baseline, 3-month, 6-month and 12-month post-commencement of intervention
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Secondary outcome [29]
444317
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percentage body fat
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Assessment method [29]
444317
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Withings bodyscan
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Timepoint [29]
444317
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Baseline and 3-month, 6-month, and 12-month post-commencement of intervention
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Secondary outcome [30]
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Cost-effectiveness analysis
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Assessment method [30]
444569
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Cost-effectiveness analysis in terms of changes in wellbeing (WEMWBS-7)
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Timepoint [30]
444569
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6 and 12-month post-commencement of the intervention
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Secondary outcome [31]
444570
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Cost-effectiveness analysis
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Assessment method [31]
444570
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Cost-effectiveness analysis in terms of changes in health-related quality of life (HRQoL)
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Timepoint [31]
444570
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6 and 12-month post-commencement of the intervention
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Secondary outcome [32]
444571
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Cost-effectiveness analysis
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Assessment method [32]
444571
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Cost-effectiveness analysis in terms of changes in and satisfaction with life (SWL-1).
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Timepoint [32]
444571
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6 and 12-month post-commencement of the intervention
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Eligibility
Key inclusion criteria
• Any academic/non-academic staff of RMIT University, Australia
• Age: 18+ years
• Expressed intent not to leave RMIT over the next 12 months from the beginning of the data collection period
• Completion of Informed Consent
• Have access to computer or smartphone devices
• Have Medicare or equivalent health insurance in Australia
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
• Suffering from severe psychological distress (assessed by Kessler-10 scale), severe depression, or suicidal ideation.
• Self-reported current meditation practice
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised (after completion of baseline data) either to treatment or control group using computer-generated random sequence numbers, by a researcher not involved in the data collection and study implementation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by using computer-generated random sequence numbers
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Statisticians will be blinded to the study group allocation.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
17/10/2024
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Date of last participant enrolment
Anticipated
22/08/2025
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Actual
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Date of last data collection
Anticipated
30/11/2026
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Actual
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Sample size
Target
122
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Accrual to date
54
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
318028
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Charities/Societies/Foundations
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Name [1]
318028
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David Lynch Foundation (DLF), philanthropic donations received by RMIT University
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Address [1]
318028
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Country [1]
318028
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Australia
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Funding source category [2]
318029
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Commercial sector/Industry
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Name [2]
318029
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Philia Labs (PL)-will provide the smartwatch at no cost with technical support
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Address [2]
318029
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Country [2]
318029
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Australia
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Primary sponsor type
University
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Name
RMIT University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320373
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Country [1]
320373
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316686
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Royal Melbourne Institute of Technology Human Research Ethics Committee
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Ethics committee address [1]
316686
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https://www.rmit.edu.au/research/our-research/ethics-and-integrity/human-ethics
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Ethics committee country [1]
316686
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Australia
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Date submitted for ethics approval [1]
316686
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17/11/2023
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Approval date [1]
316686
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12/08/2024
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Ethics approval number [1]
316686
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Summary
Brief summary
Transcendental Meditation (TM) may help prevent psychological distress while promoting mental and cardiometabolic health, but its effects remain underexplored among university staff in Australia. This two-arm, parallel-group randomised controlled trial at RMIT University will compare the effects of TM with access to the university's wellbeing program on psychological and cardiometabolic outcomes. Over 12 months, data will be collected three to four times through surveys, physical measurements (e.g., blood pressure, anthropometry), tracking using Biostrap Kairos watches (e.g. heart rate, sleep), biochemical assessments (e.g., lipid profiles, salivary cortisol, markers of insulin resistance and inflammation, telomere length), and interviews. The study aims to provide empirical evidence of TM's role in enhancing the mental and cardiometabolic health of university staff.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Barbora de Courten
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Address
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Health & Biomedical Sciences, STEM College RMIT University 124 La Trobe St Building 12, Level 7, Room 16A Melbourne, VIC 3000, Australia
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Country
138666
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Australia
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Phone
138666
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+61 3 9925 6474
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Fax
138666
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Email
138666
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[email protected]
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Contact person for public queries
Name
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Barbora de Courten
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Address
138667
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Health & Biomedical Sciences, STEM College RMIT University 124 La Trobe St Building 12, Level 7, Room 16A Melbourne, VIC 3000, Australia
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Country
138667
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Australia
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Phone
138667
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+61 3 9925 6474
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Fax
138667
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Email
138667
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[email protected]
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Contact person for scientific queries
Name
138668
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Barbora de Courten
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Address
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Health & Biomedical Sciences, STEM College RMIT University 124 La Trobe St Building 12, Level 7, Room 16A Melbourne, VIC 3000, Australia
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Country
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Australia
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Phone
138668
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+61 3 9925 6474
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Fax
138668
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Email
138668
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
This is a high-risk study involving data on biospecimen analysis, including telomere assessment. Therefore, IPD will not be available.
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
Letter.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF