Clinical trial NCT04072133: The Move Well Study
Official title: Effects of Meditative Movement on Body Composition in Midlife Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Meditative Movement on Body Composition
Keywords: Midlife Women
Body Composition
Meditative Movement
Emotional Eating
Sleep Quality
Body Fat Percentage
Tai Chi Easy
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 52
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trial with single arm
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Fat Percentage
timeFrame: 8 weeks
measure: Emotional Eating
timeFrame: 8 weeks
measure: Sleep Quality
timeFrame: 8 weeks
Secondary outcomes:
measure: Perceived Stress Scale-10
timeFrame: 8 weeks
measure: Self-Compassion Scale (SCS)
timeFrame: 8 weeks
measure: Body Awareness Questionnaire (BAQ)
timeFrame: 8 weeks
measure: Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University Downtown Campus
state: Arizona
Study officials:
References: