Healthy Weight and Stress Management Study

Obesity Clinical Trial

Official title:

Healthy Weight and Stress Management Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05279989
• Other study ID #: STUDY00014499
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 22, 2022

Study information

• Verified date: February 2023
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Muscle Weakness
• Obesity
• Physical Disability

Intervention

Other:
• Seated Tai Chi Qigong
Participants will receive seated Tai Chi Qigong videos.
• Health Information Videos
Participants will receive videos of health information.

Locations

Country	Name	City	State
United States	Edson College of Nursing and Health Innovation	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Waist Circumference assessed by measuring tape	Waist Circumference assessed by measuring tape	Baseline
Primary	Waist Circumference assessed by measuring tape	Waist Circumference (cm) assessed by measuring tape	Week 4
Primary	Waist Circumference measured by measuring tape	Waist Circumference (cm) assessed by measuring tape	Week 8
Primary	Waist Circumference measured by measuring tape	Waist Circumference (cm) assessed by measuring tape	Week 12
Primary	Handgrip strength measured by isokinetic handgrip dynamometry	Weight (kg) resisted measured by handgrip dynamometer	Baseline
Primary	Handgrip strength measured by isokinetic handgrip dynamometry	Weight (kg) resisted measured by handgrip dynamometer	Week 4
Primary	Handgrip strength measured by isokinetic handgrip dynamometry	Weight (kg) resisted measured by handgrip dynamometer	Week 8
Primary	Handgrip strength measured by isokinetic handgrip dynamometry	Weight (kg) resisted measured by handgrip dynamometer	Week 12
Primary	Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale	Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.	Baseline
Primary	Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale	Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.	Week 12
Primary	Anxiety assessed by Generalized Anxiety Disorder 7-item Scale	Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome.	Baseline
Primary	Anxiety assessed by Generalized Anxiety Disorder 7-item Scale	Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome	Week 12
Secondary	Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor	Mindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating	Baseline
Secondary	Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor	Mindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating	Week 12
Secondary	Sleep Quality assessed by the Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality	Baseline
Secondary	Sleep Quality assessed by Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality	Week 4
Secondary	Sleep Quality assessed by Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality	Week 8
Secondary	Sleep Quality assessed by Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality	Week 12
Secondary	Food Consumption Frequency assessed by the Dietary Screener Questionnaire	Dietary Screener Questionnaire responses measuring food consumption frequency	Baseline
Secondary	Food Consumption Frequency assessed by the Dietary Screener Questionnaire	Dietary Screener Questionnaire responses measuring food consumption frequency	Week 12
Secondary	Physical Functioning assessed by the Short-Form Health Survey	The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function	Baseline
Secondary	Physical Functioning assessed by The Short-Form Health Survey	The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function	Week 12
Secondary	Well-Being assessed by the Short-Form Health Survey	The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being	Baseline
Secondary	Well-Being assessed by the Short-Form Health Survey	The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being	Week 12