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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|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|
|Principal Investigator:||Karen E Atler, PhD||Colorado State University|