Clinical trial NCT04164030: Education and Exercise Program for Adults With Type 2 Diabetes
Official title: Merging Yoga, Occupational Therapy and Education in Diabetes Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: low income adults
feasibility pilot study
occupational therapy
nutrition education
yoga
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2019-11-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in habits measured using the Self-Report Habit Index
timeFrame: Pre assessment, post assessment following 9 week session and 6-8 weeks follow-up
measure: Change in diabetes distress measured using the Diabetes Distress Scale
timeFrame: Pre assessment, post assessment following 9 week session and 6-8 weeks follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Karen E Atler, PhD
role: PRINCIPAL_INVESTIGATOR
References: