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Healthy Weight and Stress Management Study

Healthy Weight and Stress Management Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05279989
Enrollment
25
Registered
2022-03-15
Start date
2021-12-01
Completion date
2022-12-22
Last updated
2023-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Muscle Weakness, Obesity, Physical Disability

Keywords

Mobility impairment, Tai Chi, Stress Management, Obesity

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.

Interventions

OTHERSeated Tai Chi Qigong

Participants will receive seated Tai Chi Qigong videos.

OTHERHealth Information Videos

Participants will receive videos of health information.

Sponsors

Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 64 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Waist Circumference assessed by measuring tapeBaselineWaist Circumference assessed by measuring tape
Waist Circumference measured by measuring tapeWeek 8Waist Circumference (cm) assessed by measuring tape
Handgrip strength measured by isokinetic handgrip dynamometryBaselineWeight (kg) resisted measured by handgrip dynamometer
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression ScaleBaselineCenter 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 ScaleBaselineGeneralized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome.

Secondary

MeasureTime frameDescription
Physical Functioning assessed by The Short-Form Health SurveyWeek 12The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function
Emotional Eating assessed by Mindful Eating Questionnaire - 5 FactorBaselineMindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating
Well-Being assessed by the Short-Form Health SurveyBaselineThe Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being
Sleep Quality assessed by the Pittsburgh Sleep Quality IndexBaselinePittsburgh 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 IndexWeek 4Pittsburgh 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 QuestionnaireBaselineDietary Screener Questionnaire responses measuring food consumption frequency
Physical Functioning assessed by the Short-Form Health SurveyBaselineThe Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026