Nutrition and Exercise Study to Understand Metabolic Syndrome

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2014

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

  • Behavioral: Health education
    • Education on lifestyle changes for treatment of metabolic syndrome
  • Behavioral: Yoga
    • Training in the practice of yoga for treatment of metabolic syndrome

Arms, Groups and Cohorts

  • Experimental: Yoga with health education
    • 12 week yoga program coupled to standardized health education for weight loss
  • Active Comparator: Health education
    • Standardized health education for weight loss

Clinical Trial Outcome Measures

Primary Measures

  • Change in insulin resistance
    • Time Frame: Baseline, 12 weeks, and 24 weeks

Secondary Measures

  • Change in hypertension
    • Time Frame: Baseline, 12, and 24 weeks
    • Blood pressure
  • Change in dyslipidemia
    • Time Frame: Baseline, 12, and 24 weeks
    • Fasting lipids
  • Change in body composition
    • Time Frame: Baseline, 12, and 24 weeks
    • Waist circumference and bioelectrical impedance
  • Change in diet
    • Time Frame: Baseline, 12, and 24 weeks
    • Dietary intake assessed with Block Brief 200 Food Frequency
  • Change in physical activity measured with accelerometers
    • Time Frame: Baseline, 12, and 24 weeks
    • Assessed with accelerometers
  • Change in self-efficacy
    • Time Frame: Baseline and 12 weeks
    • Perceived Health Competence Scale
  • Change in stress
    • Time Frame: Baseline and 12 weeks
    • Perceived Stress Scale-10
  • Change in quality of life
    • Time Frame: Baseline and 12 weeks
    • SF-36
  • Change in mindfulness
    • Time Frame: Baseline and 12 weeks
    • Mindful Attention and Awareness Scale
  • Change in affect measured through questionnaire Profile of Mood States
    • Time Frame: Baseline and 12 weeks
    • Profile of Mood States

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gurjeet Birdee, Principle Investigator – Vanderbilt University Medical Center
  • Overall Official(s)
    • Gurjeet Birdee, MD, Principal Investigator, Vanderbilt University Medical Center

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