A Phase 2 interventional study of Health education and Yoga in Metabolic Syndrome, Obesity and Insulin Resistance, sponsored by Vanderbilt University Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-02.
Sponsored by Vanderbilt University Medical Center · Phase 2, Interventional, and Treatment
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.
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 67 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
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Exclusion Criteria:
12 week yoga program coupled to standardized health education for weight loss
Behavioral: Health education · Behavioral: Yoga
Standardized health education for weight loss
Behavioral: Health education
Education on lifestyle changes for treatment of metabolic syndrome
Training in the practice of yoga for treatment of metabolic syndrome
Change in insulin resistance
Time frame: Baseline, 12 weeks, and 24 weeks
Change in hypertension
Blood pressure
Time frame: Baseline, 12, and 24 weeks
Change in dyslipidemia
Fasting lipids
Time frame: Baseline, 12, and 24 weeks
Change in body composition
Waist circumference and bioelectrical impedance
Time frame: Baseline, 12, and 24 weeks
Change in diet
Dietary intake assessed with Block Brief 200 Food Frequency
Time frame: Baseline, 12, and 24 weeks
Change in physical activity measured with accelerometers
Assessed with accelerometers
Time frame: Baseline, 12, and 24 weeks
Change in self-efficacy
Perceived Health Competence Scale
Time frame: Baseline and 12 weeks
Change in stress
Perceived Stress Scale-10
Time frame: Baseline and 12 weeks
Change in quality of life
SF-36
Time frame: Baseline and 12 weeks
Change in mindfulness
Mindful Attention and Awareness Scale
Time frame: Baseline and 12 weeks
Change in affect measured through questionnaire Profile of Mood States
Profile of Mood States
Time frame: Baseline and 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center