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
About this trial
This is an interventional treatment trial for Metabolic Syndrome
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
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
NCT ID
NCT02899910
First Posted
September 6, 2016
Last Updated
December 30, 2016
Sponsor
Vanderbilt University Medical Center
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
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Nutrition and Exercise Study to Understand Metabolic Syndrome
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