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Feasibility of Yoga for Type-2 Diabetes

Primary Purpose

Type2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iyengar yoga
Standard Exercise
Nutrition Counseling
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring Diabetes, Yoga, Physical Activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 -74 years
  2. Baseline HbA1c of 6.5 or greater
  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

Sites / Locations

  • The Miriam Hospital- CORO buildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga

Standard Exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Hemoglobin A1c
Changes in hemoglobin A1c (HbA1c) from baseline to 6 months follow up
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.
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.
Body Mass Index
Measured as body weight in kilograms divided by height in meters squared. [kilograms]/ height [meters2]),

Full Information

First Posted
July 4, 2021
Last Updated
April 18, 2023
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04982640
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
Keywords
Diabetes, Yoga, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Codes identifying randomization assignment are withheld from the research staff conducting study outcome assessments.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
12-week program, 60 minutes, twice weekly group-delivered Iyengar yoga
Arm Title
Standard Exercise
Arm Type
Active Comparator
Arm Description
12-week, 60 minutes, twice weekly group-delivered aerobic exercise (e.g., walking) program
Intervention Type
Behavioral
Intervention Name(s)
Iyengar yoga
Intervention Description
60 minute group-classes of Iyengar yoga delivered twice weekly for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Standard Exercise
Intervention Description
60 minutes, twice weekly for 12 weeks, group-based walking program
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Counseling
Intervention Description
One, 30-minute session with registered dietitian
Primary Outcome Measure Information:
Title
Feasibility assessed as session attendance
Description
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.
Time Frame
12 weeks
Title
Acceptability as indicated by participant satisfaction ratings
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Changes in hemoglobin A1c (HbA1c) from baseline to 6 months follow up
Time Frame
6 months
Title
Diabetes Distress as measured by the Problem Areas in Diabetes Scale
Description
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.
Time Frame
12 weeks
Title
Fasting Blood Glucose
Description
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.
Time Frame
12 weeks
Title
Body Mass Index
Description
Measured as body weight in kilograms divided by height in meters squared. [kilograms]/ height [meters2]),
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and older Diagnosis of type-2 diabetes, stable on medications Physician clearance Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Bock, PhD
Phone
401*793*8020
Email
Beth_Bock@Brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Walaska, BS
Phone
401-793-8022
Email
KWalaska@Lifespan.org
Facility Information:
Facility Name
The Miriam Hospital- CORO building
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth C Bock, PhD
Phone
401-793-8020
Email
Beth_Bock@Brown.edu
First Name & Middle Initial & Last Name & Degree
Kristen Walaska, BS
Phone
401-793-8022
Email
KWalaska@Lifespan.org
First Name & Middle Initial & Last Name & Degree
Beth C Bock, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of Yoga for Type-2 Diabetes

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