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Clinical Trials/NCT05571436
NCT05571436Not yet recruitingNot Applicable

iCan Diabetes Self-Management and Prevention Support Group

University of Cincinnati1 site in 1 country60 target enrollmentStarted: October 17, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Hemoglobin A1c (A1C)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention group

Experimental

iCan Diabetes Self-Management and Prevention Program

Intervention: iCan Diabetes Self-management and Prevention Support Group (Behavioral)

Outcomes

Primary Outcomes

Hemoglobin A1c (A1C)

Time Frame: 3 months

Glycemic control

Diabetes self-management behavior

Time Frame: 3 months

Diabetes Self-Management Questionnaire (DSMQ) (16 items)

Secondary Outcomes

  • Self-efficacy related to diabetes self-management(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seung-Yeon Lee

Associate Professor

University of Cincinnati

Study Sites (1)

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