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Nutrition and Exercise Study to Understand Metabolic Syndrome

Primary Purpose

Metabolic Syndrome, Obesity, Insulin Resistance

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Health education
Yoga
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Yoga with health education

    Health education

    Arm Description

    12 week yoga program coupled to standardized health education for weight loss

    Standardized health education for weight loss

    Outcomes

    Primary Outcome Measures

    Change in insulin resistance

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 6, 2016
    Last Updated
    December 30, 2016
    Sponsor
    Vanderbilt University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02899910
    Brief Title
    Nutrition and Exercise Study to Understand Metabolic Syndrome
    Official Title
    Nutrition and Exercise Study to Understand Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, Obesity, Insulin Resistance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Yoga with health education
    Arm Type
    Experimental
    Arm Description
    12 week yoga program coupled to standardized health education for weight loss
    Arm Title
    Health education
    Arm Type
    Active Comparator
    Arm Description
    Standardized health education for weight loss
    Intervention Type
    Behavioral
    Intervention Name(s)
    Health education
    Intervention Description
    Education on lifestyle changes for treatment of metabolic syndrome
    Intervention Type
    Behavioral
    Intervention Name(s)
    Yoga
    Intervention Description
    Training in the practice of yoga for treatment of metabolic syndrome
    Primary Outcome Measure Information:
    Title
    Change in insulin resistance
    Time Frame
    Baseline, 12 weeks, and 24 weeks
    Secondary Outcome Measure Information:
    Title
    Change in hypertension
    Description
    Blood pressure
    Time Frame
    Baseline, 12, and 24 weeks
    Title
    Change in dyslipidemia
    Description
    Fasting lipids
    Time Frame
    Baseline, 12, and 24 weeks
    Title
    Change in body composition
    Description
    Waist circumference and bioelectrical impedance
    Time Frame
    Baseline, 12, and 24 weeks
    Title
    Change in diet
    Description
    Dietary intake assessed with Block Brief 200 Food Frequency
    Time Frame
    Baseline, 12, and 24 weeks
    Title
    Change in physical activity measured with accelerometers
    Description
    Assessed with accelerometers
    Time Frame
    Baseline, 12, and 24 weeks
    Title
    Change in self-efficacy
    Description
    Perceived Health Competence Scale
    Time Frame
    Baseline and 12 weeks
    Title
    Change in stress
    Description
    Perceived Stress Scale-10
    Time Frame
    Baseline and 12 weeks
    Title
    Change in quality of life
    Description
    SF-36
    Time Frame
    Baseline and 12 weeks
    Title
    Change in mindfulness
    Description
    Mindful Attention and Awareness Scale
    Time Frame
    Baseline and 12 weeks
    Title
    Change in affect measured through questionnaire Profile of Mood States
    Description
    Profile of Mood States
    Time Frame
    Baseline and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gurjeet Birdee, MD
    Organizational Affiliation
    Vanderbilt University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Nutrition and Exercise Study to Understand Metabolic Syndrome

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