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NCT05571436 Clinical Trial

iCan Diabetes Self-management and Prevention Program

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
iCan Diabetes Self-Management and Prevention Support Group

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05571436
Other study ID # 2022-0532
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 17, 2022
Est. completion date August 30, 2023

Study information
Verified date October 2022
Source University of Cincinnati
Contact Seung-Yeon Lee, PhD
Phone 513-558-7508
Email lee2so@ucmail.uc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date August 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• iCan Diabetes Self-management and Prevention Support Group
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.

Locations
Country Name City State
United States University of Cincinnati Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin A1c (A1C) Glycemic control 3 months
Primary Diabetes self-management behavior Diabetes Self-Management Questionnaire (DSMQ) (16 items) 3 months
Secondary Self-efficacy related to diabetes self-management Diabetes Empowerment Scale (28 items) 3 months
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