Nutrition and Exercise Study to Understand Metabolic Syndrome

NCT ID: NCT02899910

Last Updated: 2017-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-01-31

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.

Conditions

Metabolic Syndrome; Obesity; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Yoga with health education

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

Group Type: EXPERIMENTAL

Health education

Intervention Type: BEHAVIORAL

Education on lifestyle changes for treatment of metabolic syndrome

Yoga

Intervention Type: BEHAVIORAL

Training in the practice of yoga for treatment of metabolic syndrome

Health education

Standardized health education for weight loss

Group Type: ACTIVE_COMPARATOR

Health education

Intervention Type: BEHAVIORAL

Education on lifestyle changes for treatment of metabolic syndrome

Interventions

Health education

Education on lifestyle changes for treatment of metabolic syndrome

Intervention Type: BEHAVIORAL

Yoga

Training in the practice of yoga for treatment of metabolic syndrome

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Gurjeet Birdee

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gurjeet Birdee, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Other Identifiers

Vanderbilt University

Identifier Type: -

Identifier Source: org_study_id