Type 2 DiabetesNCT04164030
Education and Exercise Program for Adults With Type 2 Diabetes
A study testing Education and Exercise Program for Adults with Type 2 Diabetes and Nutrition Education plus Occupational Therapy plus Yoga in people with Type 2 Diabetes, run by Colorado State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Education and Exercise Program for Adults with Type 2 Diabetes and Nutrition Education plus Occupational Therapy plus Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2019to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Colorado State University
Fort Collins, Colorado, 80523
Karen E Atler, PhD, 970-491-6066, Karen.Atler@colostate.edu
Arlene A Schmid, PhD, 1-970-491-7562, Arlene.Schmid@colostate.edu
About this study
Official title: Merging Yoga, Occupational Therapy and Education in Diabetes Management
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Education and Exercise Program for Adults with Type 2 Diabetes, Nutrition Education plus Occupational Therapy plus Yoga
- Keywords
- low income adults, feasibility pilot study, occupational therapy, nutrition education, yoga
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Exercise Program for Adults with Type 2 DiabetesBehavioural
Eating Smart and Being Active program
Nutrition Education plus Occupational Therapy plus YogaBehavioural
multimodal interdisciplinary approach
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education Control | Active comparator | An evidence-based nutrition program entitled Eating Smart Being Active. Delivered in a group: Meets weekly for 2 hours for 9 weeks. Receives: Behavioral: Education and Exercise Program for Adults with Type 2 Diabetes |
| Nutrition Education +OT+Yoga | Experimental | 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. Receives: Behavioral: Nutrition Education plus Occupational Therapy plus Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre assessment, post assessment following 9 week session and 6-8 weeks follow-up
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.
Measured: Pre assessment, post assessment following 9 week session and 6-8 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start26 Aug 2019
- Primary completion15 Feb 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Sponsor
- Investigators
- Karen E Atler, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164030
- Sponsor's protocol ID
- 140898
- Status last verified
- Jul 2020
- First submitted
- 16 Sep 2019
- Last updated
- 23 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Merging Yoga, Occupational Therapy and Education in Diabetes Management
- ClinicalTrials.gov ID
- NCT04164030
- Acronym / sponsor ID
- 140898
- Conditions
- Type 2 Diabetes
- Keywords
- low income adults, feasibility pilot study, occupational therapy, nutrition education, yoga
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education Control | Active comparator | Behavioral: Education and Exercise Program for Adults with Type 2 DiabetesAn evidence-based nutrition program entitled Eating Smart Being Active. Delivered in a group: Meets weekly for 2 hours for 9 weeks. |
| Nutrition Education +OT+Yoga | Experimental | Behavioral: Nutrition Education plus Occupational Therapy plus Yoga9 week group that meets twice a week for two hours each. Group occupational therapy and group yoga will be added to the nutrition program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and Exercise Program for Adults with Type 2 DiabetesEating Smart and Being Active program | Behavioural | Nutrition Education Control |
| Nutrition Education plus Occupational Therapy plus Yogamultimodal interdisciplinary approach | Behavioural | Nutrition Education +OT+Yoga |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen E Atler, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Exercise Program for Adults with Type 2 Diabetes and Nutrition Education plus Occupational Therapy plus Yoga in people with Type 2 Diabetes, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen E Atler, PhD (1-970-491-6066, Karen.Atler@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.