NCT02899910

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

September 6, 2016

Last Update Submit

December 30, 2016

Conditions

Metabolic SyndromeObesityInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Change in insulin resistance

    Baseline, 12 weeks, and 24 weeks

Secondary Outcomes (10)

  • Change in hypertension

    Baseline, 12, and 24 weeks

  • Change in dyslipidemia

    Baseline, 12, and 24 weeks

  • Change in body composition

    Baseline, 12, and 24 weeks

  • Change in diet

    Baseline, 12, and 24 weeks

  • Change in physical activity measured with accelerometers

    Baseline, 12, and 24 weeks

  • +5 more secondary outcomes

Study Arms (2)

Yoga with health education

EXPERIMENTAL

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

Behavioral: Health educationBehavioral: Yoga

Health education

ACTIVE COMPARATOR

Standardized health education for weight loss

Behavioral: Health education

Interventions

Health educationBEHAVIORAL

Education on lifestyle changes for treatment of metabolic syndrome

Health educationYoga with health education
YogaBEHAVIORAL

Training in the practice of yoga for treatment of metabolic syndrome

Yoga with health education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metabolic SyndromeObesityInsulin Resistance

Interventions

Yoga

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Gurjeet Birdee, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 14, 2016

Study Start

June 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share