Insulin Resistance, Metabolic Syndrome, Obesity
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALHealth education
Education on lifestyle changes for treatment of metabolic syndrome
BEHAVIORALYoga
Training in the practice of yoga for treatment of metabolic syndrome
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in insulin resistance | Baseline, 12 weeks, and 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in dyslipidemia | Baseline, 12, and 24 weeks | Fasting lipids |
| Change in body composition | Baseline, 12, and 24 weeks | Waist circumference and bioelectrical impedance |
| Change in diet | Baseline, 12, and 24 weeks | Dietary intake assessed with Block Brief 200 Food Frequency |
| Change in physical activity measured with accelerometers | Baseline, 12, and 24 weeks | Assessed with accelerometers |
| Change in hypertension | Baseline, 12, and 24 weeks | Blood pressure |
| Change in stress | Baseline and 12 weeks | Perceived Stress Scale-10 |
| Change in quality of life | Baseline and 12 weeks | SF-36 |
| Change in mindfulness | Baseline and 12 weeks | Mindful Attention and Awareness Scale |
| Change in affect measured through questionnaire Profile of Mood States | Baseline and 12 weeks | Profile of Mood States |
| Change in self-efficacy | Baseline and 12 weeks | Perceived Health Competence Scale |
Outcome results
None listed