Feasibility of Yoga for Type-2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982640
• Other study ID #: 1U01AT011184
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2023
• Source: The Miriam Hospital
• Contact: Beth Bock, PhD
• Phone: 401*793*8020
• Email: Beth_Bock[@]Brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Behavioral:
• Iyengar yoga
60 minute group-classes of Iyengar yoga delivered twice weekly for 12 weeks
• Standard Exercise
60 minutes, twice weekly for 12 weeks, group-based walking program
• Nutrition Counseling
One, 30-minute session with registered dietitian

Locations

Country	Name	City	State
United States	The Miriam Hospital- CORO building	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Hemoglobin A1c	Changes in hemoglobin A1c (HbA1c) from baseline to 6 months follow up	6 months
Secondary	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
Secondary	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
Secondary	Body Mass Index	Measured as body weight in kilograms divided by height in meters squared. [kilograms]/ height [meters2]),	6 months