Type2 DiabetesNCT04982640
Feasibility of Yoga for Type-2 Diabetes
A study testing Iyengar yoga, Standard Exercise and Nutrition Counseling in people with Type2 Diabetes, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Iyengar yoga, Standard Exercise and Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2022to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Diagnosis of type-2 diabetes, stable on medications
- Physician clearance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miriam Hospital- CORO building
Providence, Rhode Island, 02903
About this study
Official title: 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.
Read the 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
- Being tested
- Iyengar yoga, Standard Exercise, Nutrition Counseling
- Keywords
- Diabetes, Yoga, Physical Activity
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iyengar yogaBehavioural
60 minute group-classes of Iyengar yoga delivered twice weekly for 12 weeks
Standard ExerciseBehavioural
60 minutes, twice weekly for 12 weeks, group-based walking program
Nutrition CounselingBehavioural
One, 30-minute session with registered dietitian
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | 12-week program, 60 minutes, twice weekly group-delivered Iyengar yoga Receives: Behavioral: Iyengar yoga; Behavioral: Nutrition Counseling |
| Standard Exercise | Active comparator | 12-week, 60 minutes, twice weekly group-delivered aerobic exercise (e.g., walking) program Receives: Behavioral: Standard Exercise; Behavioral: Nutrition Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (4)
Hemoglobin A1c
Changes in hemoglobin A1c (HbA1c) from baseline to 6 months follow up
Measured: 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.
Measured: 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.
Measured: 12 weeks
Body Mass Index
Measured as body weight in kilograms divided by height in meters squared. [kilograms]/ height [meters2]),
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start24 Oct 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Bock, Ph.D., The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982640
- Sponsor's protocol ID
- 1U01AT011184
- Status last verified
- Apr 2025
- First submitted
- 4 Jul 2021
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thind H, Pekmezi D, Dunsiger S, Guthrie KM, Stroud L, Wu WC, Walaska K, Bock BC. Multi-site feasibility and fidelity of remote yoga intervention to improve management of type-2 diabetes: Design and methods of the HA1C (Healthy Active and In Control) study. Contemp Clin Trials. 2025 Apr;151:107842. doi: 10.1016/j.cct.2025.107842. Epub 2025 Feb 10.
PubMed 39938612
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Multi-site Feasibility and Fidelity of Yoga to Improve Management of Type-2 Diabetes
- ClinicalTrials.gov ID
- NCT04982640
- Acronym / sponsor ID
- 1U01AT011184
- Conditions
- Type2 Diabetes
- Keywords
- Diabetes, Yoga, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Iyengar yoga, Behavioral: Nutrition Counseling12-week program, 60 minutes, twice weekly group-delivered Iyengar yoga |
| Standard Exercise | Active comparator | Behavioral: Standard Exercise, Behavioral: Nutrition Counseling12-week, 60 minutes, twice weekly group-delivered aerobic exercise (e.g., walking) program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and older
- Diagnosis of type-2 diabetes, stable on medications
- Physician clearance
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iyengar yoga60 minute group-classes of Iyengar yoga delivered twice weekly for 12 weeks | Behavioural | Yoga |
| Standard Exercise60 minutes, twice weekly for 12 weeks, group-based walking program | Behavioural | Standard Exercise |
| Nutrition CounselingOne, 30-minute session with registered dietitian | Behavioural | Standard Exercise, Yoga |
Primary outcome
Feasibility assessed as session attendance
Time frame: 12 weeks
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.
Acceptability as indicated by participant satisfaction ratings
Time frame: 12 weeks
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.
4 secondary outcomes
Hemoglobin A1c
Time frame: 6 months
Diabetes Distress as measured by the Problem Areas in Diabetes Scale
Time frame: 12 weeks
Fasting Blood Glucose
Time frame: 12 weeks
Body Mass Index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 39938612Thind H, Pekmezi D, Dunsiger S, Guthrie KM, Stroud L, Wu WC, Walaska K, Bock BC. Multi-site feasibility and fidelity of remote yoga intervention to improve management of type-2 diabetes: Design and methods of the HA1C (Healthy Active and In Control) study. Contemp Clin Trials. 2025 Apr;151:107842. doi: 10.1016/j.cct.2025.107842. Epub 2025 Feb 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar yoga, Standard Exercise and Nutrition Counseling in people with Type2 Diabetes, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed as session attendance (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04982640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.