iCan Diabetes Self-management and Prevention Program

Not Applicable

Not yet recruiting

• Conditions: PreDiabetes; Diabetes Mellitus, Type 2
• Interventions: Behavioral: iCan Diabetes Self-management and Prevention Support Group

• Registration Number: NCT05571436
• Lead Sponsor: University of Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-07
• Last Update Posted: 2022-10-07
• Study Start: 2022-10-17
• Primary Completion: 2023-06-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	iCan Diabetes Self-management and Prevention Support Group	iCan Diabetes Self-Management and Prevention Program

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (A1C)	3 months	Glycemic control
Diabetes self-management behavior	3 months	Diabetes Self-Management Questionnaire (DSMQ) (16 items)

Secondary Outcome Measures

Name	Time	Method
Self-efficacy related to diabetes self-management	3 months	Diabetes Empowerment Scale (28 items)

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States