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Healthy Weight and Stress Management Study

Primary Purpose

Physical Disability, Obesity, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Seated Tai Chi Qigong
Health Information Videos
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Disability focused on measuring Mobility impairment, Tai Chi, Stress Management, Obesity

Eligibility Criteria

35 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Community dwelling.
  • Female.
  • Age 35-64.
  • Waist circumference >83 cm (~35 inches).
  • Have a self-reported mobility impairment due to a chronic (>1 year).
  • Physically disabling condition (regularly using an assistive device).
  • Access to an email address and a working phone, mobile device, or personal computer or device with a high-speed internet connection.
  • Understand spoken and written English and be willing to be randomized.
  • Willing to engage in the intervention for 12 weeks, be available for two Zoom calls for data collection at T1, T2, T3, and T4 (Week 1, Week 4, Week 8, and Week 12).

Exclusion Criteria:

  • People with full mobility.
  • People who have been regularly practicing (e.g., ≥2 or more times per month for the past 6 months) any form of meditative movement including, but not limited to, Yoga, Tai Chi or Qigong.
  • Pregnant, lactating, or planning to become pregnant in the next 6 months,
  • Participants outside of the age range will be excluded from participation.
  • Adults unable to consent and prisoners will be excluded.

Sites / Locations

  • Edson College of Nursing and Health Innovation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Seated Tai Chi Qigong

Control

Arm Description

Participants will receive daily text messages and emails to distribute videos and record which sessions were completed. Participants can participate in 10-, 20-, or 30- min TCQ practices. Total weekly practice time will be recommended between 50-150 minutes/week (~10-30 min/day on most days). A library of existing TCQ videos will be used. All videos will demonstrate seated practice with discussions on how to accommodate mobility limitations of various types.

The control arm will receive text messages and emails with links to health information videos for the same time lengths as the intervention group. Existing video content will be reviewed and adapted to assure avoidance of topics that can impact outcome variables.

Outcomes

Primary Outcome Measures

Waist Circumference assessed by measuring tape
Waist Circumference assessed by measuring tape
Waist Circumference assessed by measuring tape
Waist Circumference (cm) assessed by measuring tape
Waist Circumference measured by measuring tape
Waist Circumference (cm) assessed by measuring tape
Waist Circumference measured by measuring tape
Waist Circumference (cm) assessed by measuring tape
Handgrip strength measured by isokinetic handgrip dynamometry
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry
Weight (kg) resisted measured by handgrip dynamometer
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.
Anxiety assessed by Generalized Anxiety Disorder 7-item Scale
Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome.
Anxiety assessed by Generalized Anxiety Disorder 7-item Scale
Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome

Secondary Outcome Measures

Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor
Mindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating
Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor
Mindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating
Sleep Quality assessed by the Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Food Consumption Frequency assessed by the Dietary Screener Questionnaire
Dietary Screener Questionnaire responses measuring food consumption frequency
Food Consumption Frequency assessed by the Dietary Screener Questionnaire
Dietary Screener Questionnaire responses measuring food consumption frequency
Physical Functioning assessed by the Short-Form Health Survey
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function
Physical Functioning assessed by The Short-Form Health Survey
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function
Well-Being assessed by the Short-Form Health Survey
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being
Well-Being assessed by the Short-Form Health Survey
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being

Full Information

First Posted
February 15, 2022
Last Updated
February 1, 2023
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05279989
Brief Title
Healthy Weight and Stress Management Study
Official Title
Healthy Weight and Stress Management Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Approximately 1 in 10 mid-life (age 35-64) Americans have mobility impairing disabilities. People with mobility impairing disabilities are defined using the World Health Organization criteria: community living adults with mobility impairment (e.g., amputation, spinal cord injury). Women with mobility impairing disabilities often struggle with stress, abdominal fat (measured as waist circumference), lack of muscle tissue (measured as handgrip strength) and high cardiometabolic risk. This study investigates the usefulness, acceptability, and effectiveness of two strategies to reduce stress, improve health habits, reduce abdominal fat and increase muscle tissue in mid-life women with mobility impairments. These strategies involve either gentle stretching and strengthening exercises or watching informative videos.
Detailed Description
About 1 in 10 mid-life (age 35-64) Americans have mobility impairing disabilities, steadily increasing due to medical and technological innovations. People with mobility impairing disabilities (PMI) are defined using the World Health Organization criteria, as community living adults with mobility impairment (e.g., amputation, spinal cord injury). Mid-life is a critical time for people to improve their current functioning and enhance healthy aging, by improving emotional health and increasing physical activity (PA). A review showed PA improves emotional and physical health among PMI. PMI have unique challenges to meeting PA guidelines; innovative strategies are needed to achieve emotional and physical benefits for optimal health and aging. The higher prevalence of daily stress encountered by mid-life PMI is linked to emotional health and abdominal fat (cardiometabolic disease risk) that can lead to premature mortality. This is especially so for women with mobility impairment (WMI) who have higher prevalence of excess body fat, higher cardiometabolic risk, and are not eligible for most interventions that involve PA. PA interventions also increase muscle mass, which helps to prevent cardiometabolic conditions. Although vigorous PA may not be well-suited for WMI, lighter intensity PA such as Tai Chi, Qigong and Yoga-also called meditative movement-adapted for seated practice, are a possible solution. Tai Chi and Qigong have been tested in non-impaired populations. Our work combines these two forms of low-to-moderate PA meditative movement, Tai Chi and Qigong (TCQ), in a mind-body practice. Our research, and others', show that TCQ consistently shows strong improvement in women in depressive symptoms, anxiety, emotional eating, and sleep quality-all contributing to excess abdominal fat (measured as waist circumference), improved muscle tissue (measured as handgrip strength) and strongly associated with cardiometabolic risk. Conventional health assessment strategies do not always work well for PMI; recent innovations have yielded scalable, low-contact assessment. We have demonstrated robust recruitment, reliable questionnaire administration and strong intervention implementation expertise via social media, video sharing, and gaming platforms. Aim 1: Assess the potential efficacy of TCQ to reduce waist circumference and increase handgrip strength compared to controls from T1 to T2 and sustain this change to T3 and T4 when compared to control. Aim 2: Assess the potential efficacy of TCQ to reduce stress-related behaviors (depressive symptoms, anxiety, emotional eating, and sleep) that impact abdominal fat and strength when compared to control. Aim 3: Evaluate the feasibility and acceptability of an online delivered TCQ intervention in women with mobility impairments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Disability, Obesity, Muscle Weakness, Anxiety, Depression
Keywords
Mobility impairment, Tai Chi, Stress Management, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seated Tai Chi Qigong
Arm Type
Experimental
Arm Description
Participants will receive daily text messages and emails to distribute videos and record which sessions were completed. Participants can participate in 10-, 20-, or 30- min TCQ practices. Total weekly practice time will be recommended between 50-150 minutes/week (~10-30 min/day on most days). A library of existing TCQ videos will be used. All videos will demonstrate seated practice with discussions on how to accommodate mobility limitations of various types.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control arm will receive text messages and emails with links to health information videos for the same time lengths as the intervention group. Existing video content will be reviewed and adapted to assure avoidance of topics that can impact outcome variables.
Intervention Type
Other
Intervention Name(s)
Seated Tai Chi Qigong
Intervention Description
Participants will receive seated Tai Chi Qigong videos.
Intervention Type
Other
Intervention Name(s)
Health Information Videos
Intervention Description
Participants will receive videos of health information.
Primary Outcome Measure Information:
Title
Waist Circumference assessed by measuring tape
Description
Waist Circumference assessed by measuring tape
Time Frame
Baseline
Title
Waist Circumference assessed by measuring tape
Description
Waist Circumference (cm) assessed by measuring tape
Time Frame
Week 4
Title
Waist Circumference measured by measuring tape
Description
Waist Circumference (cm) assessed by measuring tape
Time Frame
Week 8
Title
Waist Circumference measured by measuring tape
Description
Waist Circumference (cm) assessed by measuring tape
Time Frame
Week 12
Title
Handgrip strength measured by isokinetic handgrip dynamometry
Description
Weight (kg) resisted measured by handgrip dynamometer
Time Frame
Baseline
Title
Handgrip strength measured by isokinetic handgrip dynamometry
Description
Weight (kg) resisted measured by handgrip dynamometer
Time Frame
Week 4
Title
Handgrip strength measured by isokinetic handgrip dynamometry
Description
Weight (kg) resisted measured by handgrip dynamometer
Time Frame
Week 8
Title
Handgrip strength measured by isokinetic handgrip dynamometry
Description
Weight (kg) resisted measured by handgrip dynamometer
Time Frame
Week 12
Title
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
Description
Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.
Time Frame
Baseline
Title
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
Description
Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.
Time Frame
Week 12
Title
Anxiety assessed by Generalized Anxiety Disorder 7-item Scale
Description
Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome.
Time Frame
Baseline
Title
Anxiety assessed by Generalized Anxiety Disorder 7-item Scale
Description
Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor
Description
Mindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating
Time Frame
Baseline
Title
Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor
Description
Mindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating
Time Frame
Week 12
Title
Sleep Quality assessed by the Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Time Frame
Baseline
Title
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Time Frame
Week 4
Title
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Time Frame
Week 8
Title
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Time Frame
Week 12
Title
Food Consumption Frequency assessed by the Dietary Screener Questionnaire
Description
Dietary Screener Questionnaire responses measuring food consumption frequency
Time Frame
Baseline
Title
Food Consumption Frequency assessed by the Dietary Screener Questionnaire
Description
Dietary Screener Questionnaire responses measuring food consumption frequency
Time Frame
Week 12
Title
Physical Functioning assessed by the Short-Form Health Survey
Description
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function
Time Frame
Baseline
Title
Physical Functioning assessed by The Short-Form Health Survey
Description
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function
Time Frame
Week 12
Title
Well-Being assessed by the Short-Form Health Survey
Description
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being
Time Frame
Baseline
Title
Well-Being assessed by the Short-Form Health Survey
Description
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being
Time Frame
Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Community dwelling. Female. Age 35-64. Waist circumference >83 cm (~35 inches). Have a self-reported mobility impairment due to a chronic (>1 year). Physically disabling condition (regularly using an assistive device). Access to an email address and a working phone, mobile device, or personal computer or device with a high-speed internet connection. Understand spoken and written English and be willing to be randomized. Willing to engage in the intervention for 12 weeks, be available for two Zoom calls for data collection at T1, T2, T3, and T4 (Week 1, Week 4, Week 8, and Week 12). Exclusion Criteria: People with full mobility. People who have been regularly practicing (e.g., ≥2 or more times per month for the past 6 months) any form of meditative movement including, but not limited to, Yoga, Tai Chi or Qigong. Pregnant, lactating, or planning to become pregnant in the next 6 months, Participants outside of the age range will be excluded from participation. Adults unable to consent and prisoners will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca E Lee, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edson College of Nursing and Health Innovation
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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