Clinical trial NCT05279989: Healthy Weight and Stress Management Study
Official title: Healthy Weight and Stress Management Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Obesity
Muscle Weakness
Anxiety
Depression
Keywords: Mobility impairment
Tai Chi
Stress Management
Obesity
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Waist Circumference assessed by measuring tape
timeFrame: Baseline
measure: Waist Circumference assessed by measuring tape
timeFrame: Week 4
measure: Waist Circumference measured by measuring tape
timeFrame: Week 8
measure: Waist Circumference measured by measuring tape
timeFrame: Week 12
measure: Handgrip strength measured by isokinetic handgrip dynamometry
timeFrame: Baseline
measure: Handgrip strength measured by isokinetic handgrip dynamometry
timeFrame: Week 4
measure: Handgrip strength measured by isokinetic handgrip dynamometry
timeFrame: Week 8
measure: Handgrip strength measured by isokinetic handgrip dynamometry
timeFrame: Week 12
measure: Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline
measure: Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
timeFrame: Week 12
measure: Anxiety assessed by Generalized Anxiety Disorder 7-item Scale
timeFrame: Baseline
measure: Anxiety assessed by Generalized Anxiety Disorder 7-item Scale
timeFrame: Week 12
Secondary outcomes:
measure: Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor
timeFrame: Baseline
measure: Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor
timeFrame: Week 12
measure: Sleep Quality assessed by the Pittsburgh Sleep Quality Index
timeFrame: Baseline
measure: Sleep Quality assessed by Pittsburgh Sleep Quality Index
timeFrame: Week 4
measure: Sleep Quality assessed by Pittsburgh Sleep Quality Index
timeFrame: Week 8
measure: Sleep Quality assessed by Pittsburgh Sleep Quality Index
timeFrame: Week 12
measure: Food Consumption Frequency assessed by the Dietary Screener Questionnaire
timeFrame: Baseline
measure: Food Consumption Frequency assessed by the Dietary Screener Questionnaire
timeFrame: Week 12
measure: Physical Functioning assessed by the Short-Form Health Survey
timeFrame: Baseline
measure: Physical Functioning assessed by The Short-Form Health Survey
timeFrame: Week 12
measure: Well-Being assessed by the Short-Form Health Survey
timeFrame: Baseline
measure: Well-Being assessed by the Short-Form Health Survey
timeFrame: Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Edson College of Nursing and Health Innovation
state: Arizona
Study officials:
affiliation: Arizona State University
name: Rebecca E Lee, PhD
role: PRINCIPAL_INVESTIGATOR
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