Healthy Weight and Stress Management Study

Sponsor

Arizona State University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05279989

Collaborator

(none)

Enrollment

Location

Arms

11.3

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Disability Obesity Muscle Weakness Anxiety Depression	Other: Seated Tai Chi Qigong Other: Health Information Videos	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Healthy Weight and Stress Management Study

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Nov 10, 2022

Anticipated Study Completion Date :

Nov 10, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Waist Circumference assessed by measuring tape [Baseline]
Waist Circumference assessed by measuring tape
Waist Circumference assessed by measuring tape [Week 4]
Waist Circumference (cm) assessed by measuring tape
Waist Circumference measured by measuring tape [Week 8]
Waist Circumference (cm) assessed by measuring tape
Waist Circumference measured by measuring tape [Week 12]
Waist Circumference (cm) assessed by measuring tape
Handgrip strength measured by isokinetic handgrip dynamometry [Baseline]
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry [Week 4]
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry [Week 8]
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry [Week 12]
Weight (kg) resisted measured by handgrip dynamometer
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale [Baseline]
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 [Week 12]
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 [Baseline]
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 [Week 12]
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 [Baseline]
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 [Week 12]
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 [Baseline]
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 [Week 4]
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 [Week 8]
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 [Week 12]
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 [Baseline]
Dietary Screener Questionnaire responses measuring food consumption frequency
Food Consumption Frequency assessed by the Dietary Screener Questionnaire [Week 12]
Dietary Screener Questionnaire responses measuring food consumption frequency
Physical Functioning assessed by the Short-Form Health Survey [Baseline]
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 [Week 12]
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 [Baseline]
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 [Week 12]
The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edson College of Nursing and Health Innovation	Phoenix	Arizona	United States	85004

Sponsors and Collaborators

Arizona State University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Arizona State University

ClinicalTrials.gov Identifier:

NCT05279989

Other Study ID Numbers:

STUDY00014499

First Posted:

Mar 15, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Arizona State University

Additional relevant MeSH terms:

Muscle Weakness

Study Results

No Results Posted as of Aug 16, 2022