Feasibility of Yoga for Type-2 Diabetes

Study Overview
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Brief Summary
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This study will randomize 90 adults with type-2 diabetes (T2DM) from three different states (RI, MA, and AL) to a 12-week program of either (1) Iyengar yoga or (2) a Standard Exercise program. Follow up assessments occur at 3 and 6-months post-intervention. Results of this study will determine the ability to deliver these interventions with strong rigor and fidelity across multiple sites and will establish the feasibility and acceptability of this intervention across racially and ethnically diverse populations. The study will also examine factors (e.g., outcome expectations, barriers to home practice) that promote long-term adherence to yoga and/or physical activity.

Official Title
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Establishing Multi-site Feasibility and Fidelity of Yoga to Improve Management of Type-2 Diabetes

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Behavioral: Iyengar yoga
* Behavioral: Standard Exercise
* Behavioral: Nutrition Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Diagnosis of type-2 diabetes, stable on medications Physician clearance Exclusion Criteria: Serious comorbid condition (such as uncontrolled hypertension, glaucoma, heart failure). Complications of diabetes such as diabetic retinopathy, neuropathy and nephropathy Serious psychiatric disorder (e.g. psychosis, major depression, panic attacks, suicidality, or substance dependence). Extremely obese (i.e. Body Mass Index > 45 kg/m2) Currently engaged in yoga, Tai Chi, or other mindfulness-based practice the past six months Pregnant or trying to become pregnant Inability to read and write English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>12-week program, 60 minutes, twice weekly group-delivered Iyengar yoga | Behavioral: Iyengar yoga<br>* 60 minute group-classes of Iyengar yoga delivered twice weekly for 12 weeks<br>Behavioral: Nutrition Counseling<br>* One, 30-minute session with registered dietitian<br>|
| Active Comparator: Standard Exercise<br>12-week, 60 minutes, twice weekly group-delivered aerobic exercise (e.g., walking) program | Behavioral: Standard Exercise<br>* 60 minutes, twice weekly for 12 weeks, group-based walking program<br>Behavioral: Nutrition Counseling<br>* One, 30-minute session with registered dietitian<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility assessed as session attendance | Each participant is scheduled for 36 classes in total. The percent of classes attended is calculated for each participant to determine feasibility. If the average percentage of classes attended for all participants exceeds 70% the intervention will be deemed feasible. | 12 weeks | 
| Acceptability as indicated by participant satisfaction ratings | The participant satisfaction scale contains 10 items using a Likert scale from 1 (not at all satisfied) to 5 (very satisfied). Scale items will be summed and averaged for each participant. Scores from all participants are averaged. If the overall average score from all participants is 4 or greater the program will be considered satisfactory. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Changes in hemoglobin A1c (HbA1c) from baseline to 6 months follow up | 6 months | 
| Diabetes Distress as measured by the Problem Areas in Diabetes Scale | The problem areas in diabetes scale is a valid and reliable measure of diabetes-related emotional distress. It contains 20 items using a Likert scale from 0 (not a problem) to 4 (serious problem). Scale items are summed and averaged. Higher scores indicate more serious emotional distress associated with managing diabetes. | 12 weeks | 
| Fasting Blood Glucose | Blood samples taken after > 12 hour fast are assessed using standard laboratory protocols. FBG levels measured as mg/dL at 12 weeks will be compared with baseline values. | 12 weeks | 
| Body Mass Index | Measured as body weight in kilograms divided by height in meters squared. [kilograms]/ height [meters2]), | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Yoga, Physical Activity