Education and Exercise Program for Adults With Type 2 Diabetes

NCT ID: NCT04164030

Last Updated: 2020-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2021-07-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Education and Exercise Program for Adults with Type 2 Diabetes

Intervention Type: BEHAVIORAL

Eating Smart and Being Active program

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.

Group Type: EXPERIMENTAL

Nutrition Education plus Occupational Therapy plus Yoga

Intervention Type: BEHAVIORAL

multimodal interdisciplinary approach

Interventions

Education and Exercise Program for Adults with Type 2 Diabetes

Eating Smart and Being Active program

Intervention Type: BEHAVIORAL

Nutrition Education plus Occupational Therapy plus Yoga

multimodal interdisciplinary approach

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Occupational Therapy Foundation

OTHER

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen E Atler, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

Colorado State University

Fort Collins, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karen E Atler, PhD

Role: CONTACT

Karen.Atler@colostate.edu

1-970-491-6066

Arlene A Schmid, PhD

Role: CONTACT

Arlene.Schmid@colostate.edu

1-970-491-7562

Facility Contacts

Karen E Atler, PhD

Role: primary

Karen.Atler@colostate.edu

970-491-6066

Arlene A Schmid, PhD

Role: backup

Arlene.Schmid@colostate.edu

1-970-491-7562

Other Identifiers

140898

Identifier Type: -

Identifier Source: org_study_id