NCT05571436

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

October 17, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 5, 2022

Last Update Submit

October 5, 2022

Conditions

Diabetes Mellitus, Type 2PreDiabetes

Keywords

Diabetes Mellitus, Type 2PrediabetesSelf-management

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin A1c (A1C)

    Glycemic control

    3 months

  • Diabetes self-management behavior

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

    3 months

Secondary Outcomes (1)

  • Self-efficacy related to diabetes self-management

    3 months

Study Arms (1)

Intervention group

EXPERIMENTAL

iCan Diabetes Self-Management and Prevention Program

Behavioral: iCan Diabetes Self-management and Prevention Support Group

Interventions

iCan Diabetes Self-management and Prevention Support GroupBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult aged 18 years or older
  • Have been diagnosed with type 2 diabetes or prediabetes
  • Can read, write, and speak in English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Seung-Yeon Lee, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Yeon Lee, PhD

CONTACT

513-558-7508lee2so@ucmail.uc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 7, 2022

Study Start

October 17, 2022

Primary Completion

June 30, 2023

Study Completion

August 30, 2023

Last Updated

October 7, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)