iCan Diabetes Self-management and Prevention Program
Primary Purpose
Diabetes Mellitus, Type 2, PreDiabetes
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iCan Diabetes Self-management and Prevention Support Group
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Prediabetes, Self-management
Eligibility Criteria
Inclusion Criteria:
- Adult aged 18 years or older
- Have been diagnosed with type 2 diabetes or prediabetes
- Can read, write, and speak in English
Exclusion Criteria:
- Attended a diabetes self-management program or diabetes prevention program within the last 3 months
- Plan to attend another diabetes self-management program or diabetes prevention program within 3 months
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
iCan Diabetes Self-Management and Prevention Program
Outcomes
Primary Outcome Measures
Hemoglobin A1c (A1C)
Glycemic control
Diabetes self-management behavior
Diabetes Self-Management Questionnaire (DSMQ) (16 items)
Secondary Outcome Measures
Self-efficacy related to diabetes self-management
Diabetes Empowerment Scale (28 items)
Full Information
NCT ID
NCT05571436
First Posted
October 5, 2022
Last Updated
October 5, 2022
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT05571436
Brief Title
iCan Diabetes Self-management and Prevention Program
Official Title
iCan Diabetes Self-Management and Prevention Support Group
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 17, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
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 purpose of this study is to test the feasibility and preliminary efficacy of the iCan Diabetes Self-Management and Prevention Support Group using a single arm clinical trial. The program is composed of six weekly sessions, and it will be implemented with 60 adults (aged 18 years or older) who have been diagnosed with type 2 diabetes or prediabetes and evaluated using mixed methods. A pre-test will be conducted before the program implementation and a post-test will be conducted three months after the pre-test. Focus groups will be conducted shortly after the last session to obtain feedback on the program. Between the last session and the post-test, weekly emails/texts will be sent to keep participants engaged and maximize retention rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, PreDiabetes
Keywords
Diabetes Mellitus, Type 2, Prediabetes, Self-management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
iCan Diabetes Self-Management and Prevention Program
Intervention Type
Behavioral
Intervention Name(s)
iCan Diabetes Self-management and Prevention Support Group
Intervention Description
Participants will be asked to attend six weekly sessions and complete pre-and post-assessments with an optional focus group.
The intervention will cover the following topics: 1) Yes, iCan! - Affirmations and Empowerment, 2) The Language of Diabetes - Diabetes Synopsis, 3) Diabetes and Me - Management Strategies, 4) Extraordinary Health - Dream Team, 5) Food for Thought - Food Conscious, and 6) Discussion - Stories/Goals.
Each session is composed of a Check-in, Affirmation/Empowerment Activity, Short Presentation, Q&A and Discussion, Goal setting, and Testing Healthy Snacks.
Primary Outcome Measure Information:
Title
Hemoglobin A1c (A1C)
Description
Glycemic control
Time Frame
3 months
Title
Diabetes self-management behavior
Description
Diabetes Self-Management Questionnaire (DSMQ) (16 items)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Self-efficacy related to diabetes self-management
Description
Diabetes Empowerment Scale (28 items)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult aged 18 years or older
Have been diagnosed with type 2 diabetes or prediabetes
Can read, write, and speak in English
Exclusion Criteria:
Attended a diabetes self-management program or diabetes prevention program within the last 3 months
Plan to attend another diabetes self-management program or diabetes prevention program within 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Yeon Lee, PhD
Phone
513-558-7508
Email
lee2so@ucmail.uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Yeon Lee, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung-Yeon Lee, PhD
Phone
513-558-7508
Email
lee2so@ucmail.uc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
iCan Diabetes Self-management and Prevention Program
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