Back to resultsTaking on Diabetes to Advance You (TODAY) (TODAY)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Taking on Diabetes to Advance You (TODAY) Project
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- type 2 diabetes
- 18 or older
- patient at the Family Medicine Center in Fort Collins
Exclusion Criteria:
- reading level below 6th grade
- inability to understand written or verbal instructions regarding questionnaires
Sites / Locations
- Family Medicine Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
TODAY Project
Arm Description
All participants will attend individualized self-management sessions led by an occupational therapist. The classes will focus on promoting modifying daily activities, habits, roles, and routines to promote healthy lifestyles for individuals with type 2 diabetes.
Outcomes
Primary Outcome Measures
The Diabetes Self-Management Questionnaire
16-item self-report to assess self-care activities associated with diabetes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03121508
Brief Title
Taking on Diabetes to Advance You (TODAY)
Acronym
TODAY
Official Title
Taking on Diabetes to Advance You
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
not enough funding to complete the project as planned
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
June 24, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arlene Schmid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The program will consist of diabetes self-management sessions, led by an occupational therapist. The sessions will be held in an individualized format. Sessions will focus on diabetes education, self-management education, and education on behaviors and adaptive techniques to optimize participation in daily life with type II diabetes. As occupational therapists, the investigators and facilitator, aim to focus on establishing healthy habits, roles, and routines for individuals with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The investigators will utilize an evidence-based self-management program, and all individuals will be assigned to the prevention group to promote healthy lifestyles.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TODAY Project
Arm Type
Other
Arm Description
All participants will attend individualized self-management sessions led by an occupational therapist. The classes will focus on promoting modifying daily activities, habits, roles, and routines to promote healthy lifestyles for individuals with type 2 diabetes.
Intervention Type
Behavioral
Intervention Name(s)
Taking on Diabetes to Advance You (TODAY) Project
Intervention Description
This is an individualized educational intervention with activity components designed to assist in modifying habits, roles, and routines to promote healthy lifestyle patterns for individuals with type 2 diabetes.
Primary Outcome Measure Information:
Title
The Diabetes Self-Management Questionnaire
Description
16-item self-report to assess self-care activities associated with diabetes
Time Frame
through the end of the intervention period, up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 2 diabetes
18 or older
patient at the Family Medicine Center in Fort Collins
Exclusion Criteria:
reading level below 6th grade
inability to understand written or verbal instructions regarding questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Malcolm, PhD
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Medicine Center
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Taking on Diabetes to Advance You (TODAY)
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