Clinical trial NCT02899910: Nutrition and Exercise Study to Understand Metabolic Syndrome
Official title: Nutrition and Exercise Study to Understand Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metabolic Syndrome
Obesity
Insulin Resistance
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in insulin resistance
timeFrame: Baseline, 12 weeks, and 24 weeks
Secondary outcomes:
measure: Change in hypertension
timeFrame: Baseline, 12, and 24 weeks
measure: Change in dyslipidemia
timeFrame: Baseline, 12, and 24 weeks
measure: Change in body composition
timeFrame: Baseline, 12, and 24 weeks
measure: Change in diet
timeFrame: Baseline, 12, and 24 weeks
measure: Change in physical activity measured with accelerometers
timeFrame: Baseline, 12, and 24 weeks
measure: Change in self-efficacy
timeFrame: Baseline and 12 weeks
measure: Change in stress
timeFrame: Baseline and 12 weeks
measure: Change in quality of life
timeFrame: Baseline and 12 weeks
measure: Change in mindfulness
timeFrame: Baseline and 12 weeks
measure: Change in affect measured through questionnaire Profile of Mood States
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Gurjeet Birdee, MD
role: PRINCIPAL_INVESTIGATOR
References: