Nutrition and Exercise Study to Understand Metabolic Syndrome
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About
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.
Full 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
67 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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