Recruiting

Education & Exercise

Sponsor:

Colorado State University

Code:

NCT04164030

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Education and Exercise Program for Adults with Type 2 Diabetes

Nutrition Education plus Occupational Therapy plus Yoga

Study Details

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.

Conditions

Type 2 Diabetes

Study ID

NCT04164030

Start date

Aug 26, 2019

Status verified date

Jul, 2020

Completion date

Jul 30, 2021

Anticipated

Primary completion date

Feb 15, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Education and Exercise Program for Adults with Type 2 Diabetes

Eating Smart and Being Active program

Nutrition Education plus Occupational Therapy plus Yoga

multimodal interdisciplinary approach

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Karen E Atler, PhD

1-970-491-6066Karen.Atler@colostate.edu

Arlene A Schmid, PhD

1-970-491-7562Arlene.Schmid@colostate.edu

Locations

Colorado State University

Recruiting

Fort Collins, Colorado, United States, 80523

Contacts

Karen E Atler, PhD

970-491-6066Karen.Atler@colostate.edu

Arlene A Schmid, PhD

1-970-491-7562Arlene.Schmid@colostate.edu

More Information

Sponsor

Colorado State University

Last update posted

Jul 23, 2020

Last verified

Jul, 2020

Keywords

  • low income adults
  • feasibility pilot study
  • occupational therapy
  • nutrition education
  • yoga

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado State University on 2020-07-23.