Family Model Diabetes Self-Management Education in Faith Based Organizations

NCT ID: NCT04256486

Last Updated: 2025-11-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2025-08-22

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Family DSMES

Group Type EXPERIMENTAL

Family Model Diabetes Self-Management Education and Support

Intervention Type BEHAVIORAL

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

Wait List

Group Type EXPERIMENTAL

Family Model Diabetes Self-Management Education and Support

Intervention Type BEHAVIORAL

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

Interventions

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Family Model Diabetes Self-Management Education and Support

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pearl McElfish, Phd, MDA

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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UAMS Institute for Community Health Innovation

Springdale, Arkansas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1R01MD013852-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

229034

Identifier Type: -

Identifier Source: org_study_id

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