The Move Well Study

NCT04072133 | Completed

• 1 other identifier: STUDY00005974
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Perceived Stress Scale-10

  8 weeks

• Self-Compassion Scale (SCS)

  8 weeks

• Body Awareness Questionnaire (BAQ)

  8 weeks

• Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

  8 weeks

Study Arms (1)

Meditative Movement Intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: Tai Chi Easy (TCE)

Meditative Movement Intervention

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Participants must be female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• years of age
• Ability to participate in low intensity activity

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University Downtown Campus

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Emotional Eating; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trial with single arm

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 28, 2019
• Study Start: March 27, 2017
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

US (1)