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

University of Arkansas

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Family Model Diabetes Self-Management Education and Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04256486

1R01MD013852-01 (U.S. NIH Grant/Contract)

229034

Details and patient eligibility

About

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.

Enrollment: 321 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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321 participants in 2 patient groups

Family DSMES

Experimental group

Treatment:

Behavioral: Family Model Diabetes Self-Management Education and Support

Wait List

Experimental group

Treatment:

Behavioral: Family Model Diabetes Self-Management Education and Support