Education and Exercise Program for Adults With Type 2 Diabetes

NCT04164030 | Unknown

• 1 other identifier: 140898
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Pre assessment, post assessment following 9 week session and 6-8 weeks follow-up

Study Arms (2)

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.

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.

Behavioral: Nutrition Education plus Occupational Therapy plus Yoga

Interventions

Education and Exercise Program for Adults with Type 2 Diabetes BEHAVIORAL

Eating Smart and Being Active program

Nutrition Education Control

Nutrition Education plus Occupational Therapy plus Yoga BEHAVIORAL

multimodal interdisciplinary approach

Nutrition Education +OT+Yoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colorado State University: lead
• American Occupational Therapy Foundation: collaborator

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Educational Status; Nutrition Assessment; Occupational Therapy; Yoga

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Karen E Atler, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen E Atler, PhD

CONTACT

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

Arlene A Schmid, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: November 15, 2019
• Study Start: August 26, 2019
• Primary Completion: February 15, 2021
• Study Completion: July 30, 2021
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

US (1)