The Move Well Study

Study Overview
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Brief Summary
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This study will explore the effects of meditative movement on body composition in a group of 60 midlife women. Women will participate in 30-minute meditative movement (MM) classes for an eight-week period. Participants will be encouraged to practice MM at home for at least 30 minutes most days per week. Participants will be asked to complete a log of their time spent doing meditative movement outside of classes.

Detailed Description
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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.

Official Title
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Effects of Meditative Movement on Body Composition in Midlife Women

Conditions
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Effects of Meditative Movement on Body Composition

Intervention / Treatment
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* Behavioral: Meditative Movement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Clinical trial with single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditative Movement Intervention<br>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. | Behavioral: Meditative Movement<br>* 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.<br>* Other names: Tai Chi Easy (TCE);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Fat Percentage | 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. | 8 weeks | 
| Emotional Eating | 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. | 8 weeks | 
| Sleep Quality | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale-10 | self-report measure of perceived stress, 10-items, Likert scale | 8 weeks | 
| Self-Compassion Scale (SCS) | self-report measure of self-compassion as measured (26 items) by self-kindness, common humanity, non-judgment | 8 weeks | 
| Body Awareness Questionnaire (BAQ) | self-report measure of experienced body awareness/iteroception, 18-items, Likert-scale | 8 weeks | 
| Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) | self-report measure of mindfulness, Likert-scale, 9-items | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midlife Women, Body Composition, Meditative Movement, Emotional Eating, Sleep Quality, Body Fat Percentage, Tai Chi Easy