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Completed

NCT Number: NCT04072133

The Move Well Study

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.

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Key information

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University Downtown Campus

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditative Movement

Behavioral

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: Tai Chi Easy (TCE)

Primary outcomes

  1. Body Fat Percentage

    Time frame: 8 weeks

    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.

  2. Emotional Eating

    Time frame: 8 weeks

    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.

  3. Sleep Quality

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Perceived Stress Scale-10

    Time frame: 8 weeks

    self-report measure of perceived stress, 10-items, Likert scale

  2. Self-Compassion Scale (SCS)

    Time frame: 8 weeks

    self-report measure of self-compassion as measured (26 items) by self-kindness, common humanity, non-judgment

  3. Body Awareness Questionnaire (BAQ)

    Time frame: 8 weeks

    self-report measure of experienced body awareness/iteroception, 18-items, Likert-scale

  4. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

    Time frame: 8 weeks

    self-report measure of mindfulness, Likert-scale, 9-items

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

Effects of Meditative Movement on Body Composition in Midlife Women

Acronym: MW

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 28, 2019
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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