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Family Model Diabetes Self-Management Education in Faith Based Organizations (FDSMEFBO)

Primary Purpose

Type 2 Diabetes

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Family Model Diabetes Self-Management Education and Support

About this trial

This is an interventional other trial for Type 2 Diabetes focused on measuring Family Model, Marshallese, Pacific Islander, Diabetes Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

self-reported Marshallese
18 years of age or older
have T2D (defined as having an HbA1c equal to or greater than 6.5)
have at least one family member willing to take part

Exclusion Criteria:

has received DSME in the past five years
has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder
plans to move out of the geographic region

Sites / Locations

UAMS NorthwestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Family DSMES

Wait List

Arm Description

Outcomes

Primary Outcome Measures

Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points

Measured by Change in Adjusted Mean HbA1c(%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, and 24 Months Post-intervention.

Secondary Outcome Measures

Full Information

NCT ID

NCT04256486

First Posted

February 3, 2020

Last Updated

January 8, 2023

Sponsor

University of Arkansas

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

1. Study Identification

Unique Protocol Identification Number

NCT04256486

Brief Title

Family Model Diabetes Self-Management Education in Faith Based Organizations

Acronym

FDSMEFBO

Official Title

Family Model Diabetes Self-Management Education in Faith Based Organizations

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 21, 2022 (Actual)

Primary Completion Date

April 2025 (Anticipated)

Study Completion Date

April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Arkansas

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study's objective is to conduct a cluster randomized control study that evaluates the effectiveness of F-DSME (Family Model Diabetes Self-Management Education) when delivered in a group setting in Marshallese Faith Based Organizations (FBO). The F-DSME has shown to be effective when delivered in patients' homes, and the proposed research will allow us to determine the F-DSME's effectiveness in a FBO setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Family Model, Marshallese, Pacific Islander, Diabetes Education

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

576 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Family DSMES

Arm Type

Experimental

Arm Title

Wait List

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Family Model Diabetes Self-Management Education and Support

Intervention Description

Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.

Primary Outcome Measure Information:

Title

Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points

Description

Time Frame

Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: self-reported Marshallese 18 years of age or older have T2D (defined as having an HbA1c equal to or greater than 6.5) have at least one family member willing to take part Exclusion Criteria: has received DSME in the past five years has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder plans to move out of the geographic region

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Betsy O'Connor, MA, BS

Phone

479-713-8687

geoconnor@uams.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Brett Rowland, MA, BS

Phone

479-713-8667

mbrowland@uams.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pearl McElfish, Phd, MDA

Organizational Affiliation

University of Arkansas

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAMS Northwest

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Janine Boyers Schuh, MA

JMBoyersschuh@uams.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Family Model Diabetes Self-Management Education in Faith Based Organizations

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