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Completed

NCT Number: NCT02899910

Nutrition and Exercise Study to Understand Metabolic Syndrome

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Education

Behavioral

Education on lifestyle changes for treatment of metabolic syndrome

Yoga

Behavioral

Training in the practice of yoga for treatment of metabolic syndrome

Primary outcomes

  1. Change in insulin resistance

    Time frame: Baseline, 12 weeks, and 24 weeks

Secondary outcomes

  1. Change in hypertension

    Time frame: Baseline, 12, and 24 weeks

    Blood pressure

  2. Change in dyslipidemia

    Time frame: Baseline, 12, and 24 weeks

    Fasting lipids

  3. Change in body composition

    Time frame: Baseline, 12, and 24 weeks

    Waist circumference and bioelectrical impedance

  4. Change in diet

    Time frame: Baseline, 12, and 24 weeks

    Dietary intake assessed with Block Brief 200 Food Frequency

  5. Change in physical activity measured with accelerometers

    Time frame: Baseline, 12, and 24 weeks

    Assessed with accelerometers

  6. Change in self-efficacy

    Time frame: Baseline and 12 weeks

    Perceived Health Competence Scale

  7. Change in stress

    Time frame: Baseline and 12 weeks

    Perceived Stress Scale-10

  8. Change in quality of life

    Time frame: Baseline and 12 weeks

    SF-36

  9. Change in mindfulness

    Time frame: Baseline and 12 weeks

    Mindful Attention and Awareness Scale

  10. Change in affect measured through questionnaire Profile of Mood States

    Time frame: Baseline and 12 weeks

    Profile of Mood States

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 14, 2016
Registry last updated
Jan 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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