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The purpose of this study is to measure the metabolic and behavioral effects of a 12-week yoga program coupled to health education (HED) compared to HED alone.
The purpose of this study is to measure the metabolic and behavioral effects of a 12-week yoga program coupled to health education (HED) compared to HED alone. In a randomized clinical trial of 90 patients (45 patients per arm), investigators will measure the effects of the two interventions on IR, HTN, dysplidemia, and body composition (See Figure 1. Study Diagram). Subjects will be scheduled for outcome assessment at baseline, 12 weeks, and 24 weeks. In addition, investigators will collect data at baseline and 12 weeks on self-efficacy, stress, mindfulness, and mood. As a sub-study to the randomized controlled trial, investigators will measure the aerobic intensity of the yoga to estimate the dose of physical exercise provided by the yoga (n=10).
Subjects willing and eligible to participate in the RCT will receive written consent. Consented subjects will be randomized to either 12 weeks of yoga with HED versus HED alone. Subjects randomized to yoga will receive 30 to 45 minutes of weekly yoga instruction, followed by 30 to 45 minutes of HED. Subjects will receive written instructions for home yoga practice and lifestyle changes based on HED. Subjects randomized to HED alone will receive a weekly standardized HED curriculum which will be attention and time matched to the yoga with HED arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga with health education | Experimental | 12 week yoga program coupled to standardized health education for weight loss |
|
| Health education | Active Comparator | Standardized health education for weight loss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health education | Behavioral | Education on lifestyle changes for treatment of metabolic syndrome |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin resistance | Baseline, 12 weeks, and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hypertension | Blood pressure | Baseline, 12, and 24 weeks |
| Change in dyslipidemia | Fasting lipids | Baseline, 12, and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gurjeet Birdee, MD | Vanderbilt University Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Yoga | Behavioral | Training in the practice of yoga for treatment of metabolic syndrome |
|
| Change in body composition | Waist circumference and bioelectrical impedance | Baseline, 12, and 24 weeks |
| Change in diet | Dietary intake assessed with Block Brief 200 Food Frequency | Baseline, 12, and 24 weeks |
| Change in physical activity measured with accelerometers | Assessed with accelerometers | Baseline, 12, and 24 weeks |
| Change in self-efficacy | Perceived Health Competence Scale | Baseline and 12 weeks |
| Change in stress | Perceived Stress Scale-10 | Baseline and 12 weeks |
| Change in quality of life | SF-36 | Baseline and 12 weeks |
| Change in mindfulness | Mindful Attention and Awareness Scale | Baseline and 12 weeks |
| Change in affect measured through questionnaire Profile of Mood States | Profile of Mood States | Baseline and 12 weeks |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |