Clinical trial NCT04982640: Feasibility of Yoga for Type-2 Diabetes
Official title: Establishing Multi-site Feasibility and Fidelity of Yoga to Improve Management of Type-2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: Diabetes
Yoga
Physical Activity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility assessed as session attendance
timeFrame: 12 weeks
measure: Acceptability as indicated by participant satisfaction ratings
timeFrame: 12 weeks
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months
measure: Diabetes Distress as measured by the Problem Areas in Diabetes Scale
timeFrame: 12 weeks
measure: Fasting Blood Glucose
timeFrame: 12 weeks
measure: Body Mass Index
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital- CORO building
state: Rhode Island
Study officials:
References: