Nutrition and Exercise Study to Understand Metabolic Syndrome
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 67
- Primary Endpoint
- Change in insulin resistance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
- •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
Arms & Interventions
Yoga with health education
12 week yoga program coupled to standardized health education for weight loss
Intervention: Health education (Behavioral)
Yoga with health education
12 week yoga program coupled to standardized health education for weight loss
Intervention: Yoga (Behavioral)
Health education
Standardized health education for weight loss
Intervention: Health education (Behavioral)
Outcomes
Primary Outcomes
Change in insulin resistance
Time Frame: Baseline, 12 weeks, and 24 weeks
Secondary Outcomes
- Change in affect measured through questionnaire Profile of Mood States(Baseline and 12 weeks)
- Change in hypertension(Baseline, 12, and 24 weeks)
- Change in stress(Baseline and 12 weeks)
- Change in mindfulness(Baseline and 12 weeks)
- Change in diet(Baseline, 12, and 24 weeks)
- Change in dyslipidemia(Baseline, 12, and 24 weeks)
- Change in body composition(Baseline, 12, and 24 weeks)
- Change in physical activity measured with accelerometers(Baseline, 12, and 24 weeks)
- Change in self-efficacy(Baseline and 12 weeks)
- Change in quality of life(Baseline and 12 weeks)
Investigators
Gurjeet Birdee
Principle Investigator
Vanderbilt University Medical Center