iCan Diabetes Self-management and Prevention Program

NCT ID: NCT05571436

Last Updated: 2022-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2023-08-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2 PreDiabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

iCan Diabetes Self-Management and Prevention Program

Group Type EXPERIMENTAL

iCan Diabetes Self-management and Prevention Support Group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Seung-Yeon Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seung-Yeon Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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Seung-Yeon Lee, PhD

Role: CONTACT

513-558-7508

Facility Contacts

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Seung-Yeon Lee, PhD

Role: primary

513-558-7508

Other Identifiers

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2022-0532

Identifier Type: -

Identifier Source: org_study_id

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