Healthy Weight and Stress Management Study

February 1, 2023 updated by: Arizona State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Edson College of Nursing and Health Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Seated Tai Chi Qigong
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.
Other: Seated Tai Chi Qigong
Participants will receive seated Tai Chi Qigong videos.
Placebo Comparator: Control
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.
Other: Health Information Videos
Participants will receive videos of health information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist Circumference assessed by measuring tape
Time Frame: Baseline
Waist Circumference assessed by measuring tape
Baseline
Waist Circumference assessed by measuring tape
Time Frame: Week 4
Waist Circumference (cm) assessed by measuring tape
Week 4
Waist Circumference measured by measuring tape
Time Frame: Week 8
Waist Circumference (cm) assessed by measuring tape
Week 8
Waist Circumference measured by measuring tape
Time Frame: Week 12
Waist Circumference (cm) assessed by measuring tape
Week 12
Handgrip strength measured by isokinetic handgrip dynamometry
Time Frame: Baseline
Weight (kg) resisted measured by handgrip dynamometer
Baseline
Handgrip strength measured by isokinetic handgrip dynamometry
Time Frame: Week 4
Weight (kg) resisted measured by handgrip dynamometer
Week 4
Handgrip strength measured by isokinetic handgrip dynamometry
Time Frame: Week 8
Weight (kg) resisted measured by handgrip dynamometer
Week 8
Handgrip strength measured by isokinetic handgrip dynamometry
Time Frame: Week 12
Weight (kg) resisted measured by handgrip dynamometer
Week 12
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
Time Frame: Baseline
Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.
Baseline
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
Time Frame: Week 12
Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.
Week 12
Anxiety assessed by Generalized Anxiety Disorder 7-item Scale
Time Frame: Baseline
Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome.
Baseline
Anxiety assessed by Generalized Anxiety Disorder 7-item Scale
Time Frame: Week 12
Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor
Time Frame: Baseline
Mindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating
Baseline
Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor
Time Frame: Week 12
Mindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating
Week 12
Sleep Quality assessed by the Pittsburgh Sleep Quality Index
Time Frame: Baseline
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Baseline
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Time Frame: Week 4
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Week 4
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Time Frame: Week 8
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Week 8
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Time Frame: Week 12
Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality
Week 12
Food Consumption Frequency assessed by the Dietary Screener Questionnaire
Time Frame: Baseline
Dietary Screener Questionnaire responses measuring food consumption frequency
Baseline
Food Consumption Frequency assessed by the Dietary Screener Questionnaire
Time Frame: Week 12
Dietary Screener Questionnaire responses measuring food consumption frequency
Week 12
Physical Functioning assessed by the Short-Form Health Survey
Time Frame: Baseline
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function
Baseline
Physical Functioning assessed by The Short-Form Health Survey
Time Frame: Week 12
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function
Week 12
Well-Being assessed by the Short-Form Health Survey
Time Frame: Baseline
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being
Baseline
Well-Being assessed by the Short-Form Health Survey
Time Frame: Week 12
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Investigators

  • Principal Investigator: Rebecca E Lee, PhD, Arizona State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

December 22, 2022

Study Completion (Actual)

December 22, 2022

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00014499

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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