Feasibility of Yoga for Type-2 Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Behavioral: Iyengar yoga; Behavioral: Nutrition Counseling; Behavioral: Standard Exercise

Detailed Description

Effective interventions are urgently needed to help adults with Type 2 diabetes (T2DM) achieve and maintain a healthy lifestyle. A significant and growing proportion of Americans, nearly 1 in 10, have T2DM. Uncontrolled diabetes causes serious damage to kidneys, eyes and nerves, and increases risk of heart disease and stroke. Controlling blood glucose is crucial to avoid these complications. Achieving glycemic control requires attention to multiple lifestyle behaviors including healthy eating and regular physical activity. However, only 39 percent of adults with diabetes are physically active. Traditional (western) exercise (e.g., walking and cycling) improves blood glucose levels in adults with T2DM. Long-term adherence is essential to maintain health benefits. However, individuals with T2DM face greater barriers to sustaining physical activity compared to their healthy peers due to the prevalence of overweight and obesity among those with T2DM and the co-morbidities of diabetes (e.g., poor circulation, foot care issues) that create more discomfort during exercise. Yoga is similar to traditional exercise in its ability to improve physical fitness but can be highly accommodating to those with physical limitations. Moreover, as a mindfulness practice, with emphasis on relaxation, meditation, and deep breathing, yoga's effects on stress reduction may have special relevance to people with T2DM. Increased mindfulness leads to improved self-care behaviors including physical activity. Recent meta-analyses suggest a beneficial effect of yoga on glycemic outcomes. However, existing studies have generally been of low quality and conducted with non-US populations.

This U01 application is the next logical step following successful conclusion of our pilot yoga intervention for adults with T2DM (R21AT008830). Feasibility and acceptability were high as measured by program attendance (> 80% of sessions), study completion (92% of participants) and participant satisfaction (M=4.6, +/- 0.57, 1-5 scale). Yoga also improved diabetes selfcare, quality of life and led to reductions in emotional distress and HbA1c. The proposed study will build on these efforts by randomizing a diverse sample of 120 adults with T2DM from three different states (RI, MA, and AL) to a 12-week program of either (1) yoga or (2) Standard Exercise (SE) with follow up at 3 and 6-months post-treatment. Results of this study will determine our 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. We will also examine factors (e.g., outcome expectations, barriers to home practice) that promote long-term adherence to yoga/physical activity. Successful conclusion of this U01 will strengthen future applications for a multi-site RCT to rigorously test the efficacy of yoga for improving HbA1c and diabetes management. If supported, yoga could offer an attractive, sustainable form of physical activity for future diabetes management programs.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • The Miriam Hospital- CORO building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years and older
2. Diagnosis of type-2 diabetes, stable on medications
3. Physician clearance

Exclusion Criteria:

1. Serious comorbid condition (such as uncontrolled hypertension, glaucoma, heart failure).
2. Complications of diabetes such as diabetic retinopathy, neuropathy and nephropathy
3. Serious psychiatric disorder (e.g. psychosis, major depression, panic attacks, suicidality, or substance dependence).
4. Extremely obese (i.e. Body Mass Index > 45 kg/m2)
5. Currently engaged in yoga, Tai Chi, or other mindfulness-based practice the past six months
6. Pregnant or trying to become pregnant
7. Inability to read and write English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Physical Activity; Yoga
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 1U01AT011184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No