iCan Diabetes Self-management and Prevention Program

Sponsor
University of Cincinnati (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05571436
Collaborator
(none)
60
1
1
10.4
5.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: iCan Diabetes Self-management and Prevention Support Group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
iCan Diabetes Self-Management and Prevention Support Group
Anticipated Study Start Date :
Oct 17, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

iCan Diabetes Self-Management and Prevention Program

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.

Outcome Measures

Primary Outcome Measures

  1. Hemoglobin A1c (A1C) [3 months]

    Glycemic control

  2. Diabetes self-management behavior [3 months]

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

Secondary Outcome Measures

  1. Self-efficacy related to diabetes self-management [3 months]

    Diabetes Empowerment Scale (28 items)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Cincinnati Cincinnati Ohio United States 45267

Sponsors and Collaborators

  • University of Cincinnati

Investigators

  • Principal Investigator: Seung-Yeon Lee, PhD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seung-Yeon Lee, Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT05571436
Other Study ID Numbers:
  • 2022-0532
First Posted:
Oct 7, 2022
Last Update Posted:
Oct 7, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seung-Yeon Lee, Associate Professor, University of Cincinnati
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2022