Nutrition and Exercise Study to Understand Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Nutrition and Exercise Study to Understand Metabolic Syndrome

Conditions
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Metabolic Syndrome, Obesity, Insulin Resistance

Intervention / Treatment
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* Behavioral: Health education
* Behavioral: Yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elevated waist circumference (Men greater than 102cm; women greater than 88cm) Impaired fasting glucose (100-125 mg/dl) Elevated blood pressure (systolic ≥130 and/or diastolic ≥ 85) Dyslipidemia (triglycerides ≥150 and/or HDL≤ 40 for men; 50 for women) Age ≥ 18 English speaking Exclusion Criteria: Currently taking blood pressure medications, oral diabetic medication or insulin, or lipid medication Systolic blood pressure ≥160 and/or diastolic ≥100 Unstable cardiac disease e.g. angina, life threatening arrhythmia Lung disease requiring oxygen supplementation at rest or with ambulation History of dementia or cognitive impairment Uncontrolled psychiatric disorders, such as major depression or psychosis Current participation in a mind-body practice/program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga with health education<br>12 week yoga program coupled to standardized health education for weight loss | Behavioral: Health education<br>* Education on lifestyle changes for treatment of metabolic syndrome<br>Behavioral: Yoga<br>* Training in the practice of yoga for treatment of metabolic syndrome<br>|
| Active Comparator: Health education<br>Standardized health education for weight loss | Behavioral: Health education<br>* Education on lifestyle changes for treatment of metabolic syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin resistance |  | Baseline, 12 weeks, and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hypertension | Blood pressure | Baseline, 12, and 24 weeks | 
| Change in dyslipidemia | Fasting lipids | Baseline, 12, and 24 weeks | 
| 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 |