Family Model Diabetes Self-Management Education in Faith Based Organizations

Type 2 Diabetes Clinical Trial

— FDSMEFBO  

Official title:

Family Model Diabetes Self-Management Education in Faith Based Organizations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04256486
• Other study ID #: 229034
• Secondary ID: 1R01MD013852-01
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2022
• Est. completion date: April 2025

Study information

• Verified date: November 2023
• Source: University of Arkansas
• Contact: Betsy O'Connor, MA, BS
• Phone: 479-713-8687
• Email: geoconnor[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 576
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UAMS Northwest	Springdale	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-intervention