Yoga for the Treatment of Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      We tested the following hypotheses:

        1. That a standardized yoga therapy will improve insulin sensitivity (primary outcome), and
           other features of the metabolic syndrome such as hypertension and dyslipidemia
           (secondary outcomes), we will perform a 2-hour oral glucose tolerance test, fasting
           blood tests, and a physical examination before and after randomization of subjects to a
           10-week yoga therapy intervention or wait-list control group.

        2. That a yoga therapy is feasible in overweight and underactive individuals with the
           metabolic syndrome, that adherence to a yoga intervention is acceptable, and that yoga
           therapy is associated with improved quality of life, we will assess the adherence to
           twice-weekly yoga group sessions (for weeks1-5) and weekly yoga group sessions (for
           weeks 6-10), frequency of home yoga therapy practice, and self-reported quality of life
           before and after the intervention in both treatment groups.

        3. To elucidate a potential mechanism for the effect of yoga on changes in insulin
           resistance by evaluating markers of inflammation from adipose tissue (adipocytokines).
           We hypothesize that these biochemical parameters will show modest improvement with yoga
           therapy and that changes in these parameters will be associated with improvements in
           insulin sensitivity.
    

Detailed description: 
      Study Interventions: There will be a 12-week intervention period.

        1. Yoga Therapy Group: Those randomized to yoga therapy will receive twice-weekly group
           yoga sessions at the Osher Center for the entire intervention period. The yoga postures
           and breathing techniques will be taught by a qualified and certified yoga instructor
           using a standardized protocol that was determined by a Yoga Expert Panel. Each group
           yoga session will take approximately 90 minutes. Participants will also be required to
           practice yoga at home at least 3 times per week, and be given yoga materials (mat,
           blocks, straps), an instruction manual, and a video for their use at home. They will be
           asked to keep a calendar log of the dates/times that they practiced yoga at home. This
           group will also receive a 20-30 minute session with a counselor to discuss Standard
           Health Education at the beginning of the 12-week intervention. This session will be
           similar to the control group intervention.

        2. Standard Health Education Group: Participants assigned to the standard health education
           group will receive an individual 20-30 minute session with a trained research associate
           within a week of their baseline visit. In this session, participants will be informed of
           the importance of a healthy lifestyle, given written information of the Food Guide
           Pyramid12 and told to follow the equivalent of the National Cholesterol Education
           Program Step I diet13. They will be counseled to reduce weight and increase physical
           activity. This is similar to the intervention given to the "Standard Lifestyle Group" in
           the Diabetes Prevention Program4.
    

Intervention name(s): Restorative yoga therapy
Intervention type(s): Behavioral
Intervention description(s): 3-hour workshop at study initiation. Then twice-weekly group yoga classes for 5 weeks, then once-weekly group yoga classes for 5 weeks. Home yoga practice for 90 minutes/week throughout the 10 week trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: overweight; sedentary; metabolic syndrome