Healthy Weight and Stress Management Study
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| ClinicalTrials.gov Identifier: NCT05279989 |
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Recruitment Status :
Completed
First Posted : March 15, 2022
Last Update Posted : February 2, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Physical Disability Obesity Muscle Weakness Anxiety Depression | Other: Seated Tai Chi Qigong Other: Health Information Videos | Not Applicable |
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 (Clinical Trial) |
| Actual 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 : | December 1, 2021 |
| Actual Primary Completion Date : | December 22, 2022 |
| Actual Study Completion Date : | December 22, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Other: Seated Tai Chi Qigong
Participants will receive seated Tai Chi Qigong videos. |
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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.
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Other: Health Information Videos
Participants will receive videos of health information. |
- Waist Circumference assessed by measuring tape [ Time Frame: Baseline ]Waist Circumference assessed by measuring tape
- Waist Circumference assessed by measuring tape [ Time Frame: Week 4 ]Waist Circumference (cm) assessed by measuring tape
- Waist Circumference measured by measuring tape [ Time Frame: Week 8 ]Waist Circumference (cm) assessed by measuring tape
- Waist Circumference measured by measuring tape [ Time Frame: Week 12 ]Waist Circumference (cm) assessed by measuring tape
- Handgrip strength measured by isokinetic handgrip dynamometry [ Time Frame: Baseline ]Weight (kg) resisted measured by handgrip dynamometer
- Handgrip strength measured by isokinetic handgrip dynamometry [ Time Frame: Week 4 ]Weight (kg) resisted measured by handgrip dynamometer
- Handgrip strength measured by isokinetic handgrip dynamometry [ Time Frame: Week 8 ]Weight (kg) resisted measured by handgrip dynamometer
- Handgrip strength measured by isokinetic handgrip dynamometry [ Time Frame: Week 12 ]Weight (kg) resisted measured by handgrip dynamometer
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Food Consumption Frequency assessed by the Dietary Screener Questionnaire [ Time Frame: Baseline ]Dietary Screener Questionnaire responses measuring food consumption frequency
- Food Consumption Frequency assessed by the Dietary Screener Questionnaire [ Time Frame: Week 12 ]Dietary Screener Questionnaire responses measuring food consumption frequency
- 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
- 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
- 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
- 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
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| Ages Eligible for Study: | 35 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05279989
| United States, Arizona | |
| Edson College of Nursing and Health Innovation | |
| Phoenix, Arizona, United States, 85004 | |
| Principal Investigator: | Rebecca E Lee, PhD | Arizona State University |
| Responsible Party: | Arizona State University |
| ClinicalTrials.gov Identifier: | NCT05279989 |
| Other Study ID Numbers: |
STUDY00014499 |
| First Posted: | March 15, 2022 Key Record Dates |
| Last Update Posted: | February 2, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Mobility impairment Tai Chi Stress Management Obesity |
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Muscle Weakness Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations |
Neurologic Manifestations Nervous System Diseases Pathologic Processes |