Family Model Diabetes Self-Management Education in Faith Based Organizations

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Family Model Diabetes Self-Management Education and Support

• Registration Number: NCT04256486
• Lead Sponsor: University of Arkansas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-05
• Study Start: 2022-04-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 321

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Family DSMES	Family Model Diabetes Self-Management Education and Support	-
Wait List	Family Model Diabetes Self-Management Education and Support	-

Primary Outcome Measures

Name	Time	Method
Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points	Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention	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.

Trial Locations

Locations (1)

UAMS Institute for Community Health Innovation; 🇺🇸 Springdale, Arkansas, United States