Nutrition and Exercise Study to Understand Metabolic Syndrome

Obesity Clinical Trial

Official title:

Nutrition and Exercise Study to Understand Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899910
• Other study ID #: Vanderbilt University
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2016
• Last updated: December 30, 2016
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2016
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Syndrome

Intervention

Behavioral:
• Health education
Education on lifestyle changes for treatment of metabolic syndrome
• Yoga
Training in the practice of yoga for treatment of metabolic syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin resistance		Baseline, 12 weeks, and 24 weeks	No
Secondary	Change in hypertension	Blood pressure	Baseline, 12, and 24 weeks	No
Secondary	Change in dyslipidemia	Fasting lipids	Baseline, 12, and 24 weeks	No
Secondary	Change in body composition	Waist circumference and bioelectrical impedance	Baseline, 12, and 24 weeks	No
Secondary	Change in diet	Dietary intake assessed with Block Brief 200 Food Frequency	Baseline, 12, and 24 weeks	No
Secondary	Change in physical activity measured with accelerometers	Assessed with accelerometers	Baseline, 12, and 24 weeks	No
Secondary	Change in self-efficacy	Perceived Health Competence Scale	Baseline and 12 weeks	No
Secondary	Change in stress	Perceived Stress Scale-10	Baseline and 12 weeks	No
Secondary	Change in quality of life	SF-36	Baseline and 12 weeks	No
Secondary	Change in mindfulness	Mindful Attention and Awareness Scale	Baseline and 12 weeks	No
Secondary	Change in affect measured through questionnaire Profile of Mood States	Profile of Mood States	Baseline and 12 weeks	No