Feasibility of Yoga for Type-2 Diabetes

NCT ID: NCT04982640

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2025-01-31

Brief Summary

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.

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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Yoga

12-week program, 60 minutes, twice weekly group-delivered Iyengar yoga

Group Type: EXPERIMENTAL

Iyengar yoga

Intervention Type: BEHAVIORAL

60 minute group-classes of Iyengar yoga delivered twice weekly for 12 weeks

Nutrition Counseling

Intervention Type: BEHAVIORAL

One, 30-minute session with registered dietitian

Standard Exercise

12-week, 60 minutes, twice weekly group-delivered aerobic exercise (e.g., walking) program

Group Type: ACTIVE_COMPARATOR

Standard Exercise

Intervention Type: BEHAVIORAL

60 minutes, twice weekly for 12 weeks, group-based walking program

Nutrition Counseling

Intervention Type: BEHAVIORAL

One, 30-minute session with registered dietitian

Interventions

Iyengar yoga

60 minute group-classes of Iyengar yoga delivered twice weekly for 12 weeks

Intervention Type: BEHAVIORAL

Standard Exercise

60 minutes, twice weekly for 12 weeks, group-based walking program

Intervention Type: BEHAVIORAL

Nutrition Counseling

One, 30-minute session with registered dietitian

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Beth Bock, Ph.D.

Senior Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Miriam Hospital- CORO building

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1U01AT011184

Identifier Type: -

Identifier Source: org_study_id