- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04072133
The Move Well Study (MW)
Effects of Meditative Movement on Body Composition in Midlife Women
Study Overview
Status
Intervention / Treatment
Detailed Description
A growing body of published evidence indicates that meditative movement (MM) practices may be helpful for body composition improvement. Less strenuous forms of exercise that include a focus on the breath and meditative state (i.e., "meditative movement" such as Yoga, Qigong, or Tai Chi) may be easier to adopt for unfit, sedentary, overweight or obese women, which characterizes a large percentage of the general population. Despite this preliminary evidence, no studies have proposed a model for how or why weight loss might occur in MM interventions where the goals are not designated as weight loss, nutritional counseling is not included, and energy expenditure is not at the level assumed to be required to achieve weight loss. The proposed intervention is designed to refine and gather preliminary evidence for a novel "mindful-body-wisdom" model of intervening on improving body composition and to examine the contribution of model factors (psychological and behavioral) of how such a non-diet/non-vigorous exercise intervention might work, in 60 midlife women.
TCE is a simple TC/QG form that was developed by Dr. Roger Jahnke and developed into a standardized research intervention protocol by a team of researchers. It has been used in several prior projects and one recently completed NIH/NCCAM-funded randomized controlled trial (RCT) with breast cancer survivors showing reduction in fatigue and depression, and improved sleep and physical function.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85004
- Arizona State University Downtown Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female
- 45-75 years of age
- Ability to participate in low intensity activity
Exclusion Criteria:
- Women who are unable to stand for 10-minute segments (e.g., wheelchair or walker bound and too weak)
- Women who are unable to walk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Meditative Movement Intervention
Participants will complete the following components of baseline (T1) data collection: demographics, biometric measurements, a heart rate variability assessment, and questionnaires.
Participants will be asked to provide six saliva samples via passive drool to measure cortisol levels.
Participants will be assigned into hour-long meditative movement (MM) classes for eight weeks total.
Participants will be asked to practice their MM skills at home for at least 30 minutes most days per week.
The study will distribute hard-copy movement manuals and DVD instruction videos for guidance.
Participants will be asked to provide a log of all dates and lengths of their at-home practice.
After the eighth class, participants will return for post-intervention (T2) data collection, consisting of biometric measurements, a heart rate variability assessment, and questionnaires.
Participants will provide six more saliva samples via passive drool method.
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Intervention will be taught by a certified Tai Chi Easy (TCE) group practice leader.
The TCE movements will be repeated in differing sequences and time-frames during the course of the study.
The variety and combination of the exercises will begin easy and progress to more advanced movements and/or intensities as the study progresses and participants become more experienced and comfortable with the routine.
Participants spend one hour in class each week for a total of eight weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Fat Percentage
Time Frame: 8 weeks
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Body fat percentage will be measured using Bioelectric Impedance Analysis (BIA) via the Tanita monitor.
Score range= 0% to 100%.
A higher score indicates a higher body fat percentage.
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8 weeks
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Emotional Eating
Time Frame: 8 weeks
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Emotional eating will be measured using the Three Factor Eating Questionnaire (TFEQ) (21 items, 4-point Likert scale with response options 1 through 4 for items 1 through 17, response options 1 through 8 for item 18).
Score range= 18 to 76. Emotional eating sub-score is calculated by combining six items of the TFEQ.
A higher score indicates greater emotional eating.
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8 weeks
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Sleep Quality
Time Frame: 8 weeks
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Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI) (10 items, 4-point Likert scale; 0= positive extreme of scale, 3= negative extreme of scale).
Score range= 0 to 21.
A higher score indicates worse sleep quality.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale-10
Time Frame: 8 weeks
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self-report measure of perceived stress, 10-items, Likert scale
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8 weeks
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Self-Compassion Scale (SCS)
Time Frame: 8 weeks
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self-report measure of self-compassion as measured (26 items) by self-kindness, common humanity, non-judgment
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8 weeks
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Body Awareness Questionnaire (BAQ)
Time Frame: 8 weeks
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self-report measure of experienced body awareness/iteroception, 18-items, Likert-scale
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8 weeks
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Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Time Frame: 8 weeks
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self-report measure of mindfulness, Likert-scale, 9-items
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8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00005974
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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