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Education and Exercise Program for Adults With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education and Exercise Program for Adults with Type 2 Diabetes
Nutrition Education plus Occupational Therapy plus Yoga
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring low income adults, feasibility pilot study, occupational therapy, nutrition education, yoga

Eligibility Criteria

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

Inclusion Criteria:

  • Ability to speak English and answer questions/communicate
  • Self-report diagnosis of Type 2 Diabetes
  • Self-report of children living at home
  • Self-report of low socioeconomic status or use of food assistance programs

Exclusion Criteria:

  • pregnant or anticipation of becoming pregnant in the next 6 months
  • completion of Type 2 Diabetes self-management or participation in occupational therapy with an emphasis on managing diabetes or other chronic condition in the last year.

Sites / Locations

  • Colorado State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nutrition Education Control

Nutrition Education +OT+Yoga

Arm Description

An evidence-based nutrition program entitled Eating Smart Being Active. Delivered in a group: Meets weekly for 2 hours for 9 weeks.

9 week group that meets twice a week for two hours each. Group occupational therapy and group yoga will be added to the nutrition program.

Outcomes

Primary Outcome Measures

Change in habits measured using the Self-Report Habit Index
The Self-Report Habit Index contains 12 items that measures habit strength, including automaticity, repeated character of the behavior and the sense of identity the behavior reflects. A 5 point likert scale (ranging from strongly agree (4), to strongly disagree (0) ) is used to score each item. The Self-Report Habit Index yields a total score by summing all of the items together. The total score ranges from 0 - 48, with a higher score representing a stronger habit.
Change in diabetes distress measured using the Diabetes Distress Scale
The Diabetes Distress Scale contains 17 items, which assess causes of burden and worries related to managing a chronic disease as diabetes. A 6 point likert scale (1 = no problem; 6 = severe problem) is used to score each item. The Diabetes Distress Scale yields a total score and 4 sub scale scores, including emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. The total score and sub scale scores are calculated by summing the responses of the number of items and dividing by the number of items. There are five items for emotional burden, 4 items for physician-related distress, 5 items for regimen-related distress, and 3 items for interpersonal distress. Therefore, the total and sub-scores are each reported as a mean item score, ranging from 1-6, with a higher score representing greater distress reported.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2019
Last Updated
July 22, 2020
Sponsor
Colorado State University
Collaborators
American Occupational Therapy Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04164030
Brief Title
Education and Exercise Program for Adults With Type 2 Diabetes
Official Title
Merging Yoga, Occupational Therapy and Education in Diabetes Management
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
February 15, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colorado State University
Collaborators
American Occupational Therapy Foundation

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this two phase study is to: 1) develop and 2) assess a program titled: Merging Yoga, Occupational Therapy and Nutrition Education (MY-OT-Ed) designed for low income adults with Type 2 Diabetes. Half of the participants will participate in the Nutrition Education, and the other half of the participants will participate in Nutrition Education plus Occupational Therapy group and group yoga.
Detailed Description
Merging Yoga, Occupational Therapy and Nutrition Education (MY-OT-Ed) is an interdisciplinary program designed to help low income adults with Type 2 Diabetes engage fully in life while learning to manage their diabetes. The aim is to empower individuals to embed diabetes self-management into everyday activities and routines while upholding quality of life. Currently Extension Services bring nutrition education to the under-served population in the local communities through the Expanded Food and Nutrition Education Program (EFNEP). Colorado EFNEP uses the evidence-based, healthy eating and active living curriculum, Eating Smart • Being Active (ESBA), with adult participants. While EFNEP may be helpful in the management of some aspects of diabetes care, it is not designed to address the established self-care behaviors and routines essential for effective diabetes self management. Therefore, it is critical to merge nutrition education programs such as EFNEP with other established interventions to best meet the needs of the individual with diabetes. Likewise, yoga is an effective form of physical activity to manage some aspects of diabetes care and outcomes. However, yoga is also not enough to address all of the needs of the individual. Furthermore, evidence for the success of occupational therapy's role in diabetes self-management is growing as a way to manage some aspects of the complexity of diabetes care or routines in everyday life. Our aim in this study is to follow best practice and create and evaluate an interdisciplinary approach to type 2 diabetes self-management by merging together yoga, occupational therapy and nutritional education to improve diabetes related outcomes in our population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
low income adults, feasibility pilot study, occupational therapy, nutrition education, yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutrition Education Control
Arm Type
Active Comparator
Arm Description
An evidence-based nutrition program entitled Eating Smart Being Active. Delivered in a group: Meets weekly for 2 hours for 9 weeks.
Arm Title
Nutrition Education +OT+Yoga
Arm Type
Experimental
Arm Description
9 week group that meets twice a week for two hours each. Group occupational therapy and group yoga will be added to the nutrition program.
Intervention Type
Behavioral
Intervention Name(s)
Education and Exercise Program for Adults with Type 2 Diabetes
Intervention Description
Eating Smart and Being Active program
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education plus Occupational Therapy plus Yoga
Intervention Description
multimodal interdisciplinary approach
Primary Outcome Measure Information:
Title
Change in habits measured using the Self-Report Habit Index
Description
The Self-Report Habit Index contains 12 items that measures habit strength, including automaticity, repeated character of the behavior and the sense of identity the behavior reflects. A 5 point likert scale (ranging from strongly agree (4), to strongly disagree (0) ) is used to score each item. The Self-Report Habit Index yields a total score by summing all of the items together. The total score ranges from 0 - 48, with a higher score representing a stronger habit.
Time Frame
Pre assessment, post assessment following 9 week session and 6-8 weeks follow-up
Title
Change in diabetes distress measured using the Diabetes Distress Scale
Description
The Diabetes Distress Scale contains 17 items, which assess causes of burden and worries related to managing a chronic disease as diabetes. A 6 point likert scale (1 = no problem; 6 = severe problem) is used to score each item. The Diabetes Distress Scale yields a total score and 4 sub scale scores, including emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. The total score and sub scale scores are calculated by summing the responses of the number of items and dividing by the number of items. There are five items for emotional burden, 4 items for physician-related distress, 5 items for regimen-related distress, and 3 items for interpersonal distress. Therefore, the total and sub-scores are each reported as a mean item score, ranging from 1-6, with a higher score representing greater distress reported.
Time Frame
Pre assessment, post assessment following 9 week session and 6-8 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to speak English and answer questions/communicate Self-report diagnosis of Type 2 Diabetes Self-report of children living at home Self-report of low socioeconomic status or use of food assistance programs Exclusion Criteria: pregnant or anticipation of becoming pregnant in the next 6 months completion of Type 2 Diabetes self-management or participation in occupational therapy with an emphasis on managing diabetes or other chronic condition in the last year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen E Atler, PhD
Phone
1-970-491-6066
Email
Karen.Atler@colostate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Arlene A Schmid, PhD
Phone
1-970-491-7562
Email
Arlene.Schmid@colostate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen E Atler, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen E Atler, PhD
Phone
970-491-6066
Email
Karen.Atler@colostate.edu
First Name & Middle Initial & Last Name & Degree
Arlene A Schmid, PhD
Phone
1-970-491-7562
Email
Arlene.Schmid@colostate.edu

12. IPD Sharing Statement

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Education and Exercise Program for Adults With Type 2 Diabetes

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