Nutrition and Exercise Study to Understand Metabolic Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga with health education
12 week yoga program coupled to standardized health education for weight loss
|
Education on lifestyle changes for treatment of metabolic syndrome
Training in the practice of yoga for treatment of metabolic syndrome
|
|
Active Comparator: Health education
Standardized health education for weight loss
|
Education on lifestyle changes for treatment of metabolic syndrome
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in insulin resistance
Time Frame: Baseline, 12 weeks, and 24 weeks
|
Baseline, 12 weeks, and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in hypertension
Time Frame: Baseline, 12, and 24 weeks
|
Blood pressure
|
Baseline, 12, and 24 weeks
|
|
Change in dyslipidemia
Time Frame: Baseline, 12, and 24 weeks
|
Fasting lipids
|
Baseline, 12, and 24 weeks
|
|
Change in body composition
Time Frame: Baseline, 12, and 24 weeks
|
Waist circumference and bioelectrical impedance
|
Baseline, 12, and 24 weeks
|
|
Change in diet
Time Frame: Baseline, 12, and 24 weeks
|
Dietary intake assessed with Block Brief 200 Food Frequency
|
Baseline, 12, and 24 weeks
|
|
Change in physical activity measured with accelerometers
Time Frame: Baseline, 12, and 24 weeks
|
Assessed with accelerometers
|
Baseline, 12, and 24 weeks
|
|
Change in self-efficacy
Time Frame: Baseline and 12 weeks
|
Perceived Health Competence Scale
|
Baseline and 12 weeks
|
|
Change in stress
Time Frame: Baseline and 12 weeks
|
Perceived Stress Scale-10
|
Baseline and 12 weeks
|
|
Change in quality of life
Time Frame: Baseline and 12 weeks
|
SF-36
|
Baseline and 12 weeks
|
|
Change in mindfulness
Time Frame: Baseline and 12 weeks
|
Mindful Attention and Awareness Scale
|
Baseline and 12 weeks
|
|
Change in affect measured through questionnaire Profile of Mood States
Time Frame: Baseline and 12 weeks
|
Profile of Mood States
|
Baseline and 12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gurjeet Birdee, MD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vanderbilt University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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