ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutrition and Exercise Study to Understand Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02899910
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Gurjeet Birdee, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obesity Insulin Resistance Behavioral: Health education Behavioral: Yoga Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutrition and Exercise Study to Understand Metabolic Syndrome
Study Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yoga with health education
12 week yoga program coupled to standardized health education for weight loss
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

Active Comparator: Health education
Standardized health education for weight loss
Behavioral: Health education
Education on lifestyle changes for treatment of metabolic syndrome




Primary Outcome Measures :
  1. Change in insulin resistance [ Time Frame: Baseline, 12 weeks, and 24 weeks ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899910


Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Gurjeet Birdee, MD Vanderbilt University Medical Center

Responsible Party: Gurjeet Birdee, Principle Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02899910     History of Changes
Other Study ID Numbers: Vanderbilt University
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Insulin Resistance
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases