Healthy Weight and Stress Management Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Waist Circumference measured by measuring tape
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Community dwelling.
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Seated Tai Chi Qigong (Other)
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.
干预措施: Health Information Videos (Other)
结局指标
主要结局
Waist Circumference measured by measuring tape
时间窗: Week 12
Waist Circumference (cm) assessed by measuring tape
Handgrip strength measured by isokinetic handgrip dynamometry
时间窗: Week 12
Weight (kg) resisted measured by handgrip dynamometer
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
时间窗: 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
时间窗: Week 12
Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome
Waist Circumference assessed by measuring tape
时间窗: Week 4
Waist Circumference (cm) assessed by measuring tape
Waist Circumference assessed by measuring tape
时间窗: Baseline
Waist Circumference assessed by measuring tape
Waist Circumference measured by measuring tape
时间窗: Week 8
Waist Circumference (cm) assessed by measuring tape
Handgrip strength measured by isokinetic handgrip dynamometry
时间窗: Baseline
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry
时间窗: Week 4
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry
时间窗: Week 8
Weight (kg) resisted measured by handgrip dynamometer
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
时间窗: Baseline
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
时间窗: Baseline
Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome.
次要结局
- Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor(Week 12)
- Sleep Quality assessed by the Pittsburgh Sleep Quality Index(Baseline)
- Sleep Quality assessed by Pittsburgh Sleep Quality Index(Week 12)
- Food Consumption Frequency assessed by the Dietary Screener Questionnaire(Week 12)
- Physical Functioning assessed by the Short-Form Health Survey(Baseline)
- Physical Functioning assessed by The Short-Form Health Survey(Week 12)
- Well-Being assessed by the Short-Form Health Survey(Week 12)
- Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor(Baseline)
- Sleep Quality assessed by Pittsburgh Sleep Quality Index(Week 4)
- Sleep Quality assessed by Pittsburgh Sleep Quality Index(Week 8)
- Food Consumption Frequency assessed by the Dietary Screener Questionnaire(Baseline)
- Well-Being assessed by the Short-Form Health Survey(Baseline)