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Education and Exercise Program for Adults With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT04164030
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
American Occupational Therapy Foundation
Information provided by (Responsible Party):
Colorado State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Education and Exercise Program for Adults with Type 2 Diabetes Behavioral: Nutrition Education plus Occupational Therapy plus Yoga Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Merging Yoga, Occupational Therapy and Education in Diabetes Management
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Nutrition Education Control
An evidence-based nutrition program entitled Eating Smart Being Active. Delivered in a group: Meets weekly for 2 hours for 9 weeks.
 Behavioral: Education and Exercise Program for Adults with Type 2 Diabetes
Eating Smart and Being Active program
Experimental: Nutrition Education +OT+Yoga
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.
 Behavioral: Nutrition Education plus Occupational Therapy plus Yoga
multimodal interdisciplinary approach


Outcome Measures
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Primary Outcome Measures :
  1. Change in habits measured using the Self-Report Habit Index [ Time Frame: Pre assessment, post assessment following 9 week session and 6-8 weeks follow-up ]
    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.

  2. Change in diabetes distress measured using the Diabetes Distress Scale [ Time Frame: Pre assessment, post assessment following 9 week session and 6-8 weeks follow-up ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164030


Contacts
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Contact: Karen E Atler, PhD 1-970-491-6066 Karen.Atler@colostate.edu
Contact: Arlene A Schmid, PhD 1-970-491-7562 Arlene.Schmid@colostate.edu

Locations
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United States, Colorado
Colorado State University Recruiting
Fort Collins, Colorado, United States, 80523
Contact: Karen E Atler, PhD    970-491-6066    Karen.Atler@colostate.edu   
Contact: Arlene A Schmid, PhD    1-970-491-7562    Arlene.Schmid@colostate.edu   
Sponsors and Collaborators
Colorado State University
American Occupational Therapy Foundation
Investigators
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Principal Investigator: Karen E Atler, PhD Colorado State University
More Information
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Responsible Party: Colorado State University
ClinicalTrials.gov Identifier: NCT04164030    
Other Study ID Numbers: 140898
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Colorado State University:
low income adults
feasibility pilot study
occupational therapy
nutrition education
yoga
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases