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Family Model Diabetes Self-Management Education in Faith Based Organizations

Family Model Diabetes Self-Management Education in Faith Based Organizations

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04256486
Acronym
FDSMEFBO
Enrollment
321
Registered
2020-02-05
Start date
2022-04-21
Completion date
2025-08-22
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Family Model, Marshallese, Pacific Islander, Diabetes Education

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.

Interventions

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

Sponsors

University of Arkansas
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time pointsBaseline, Immediate Post-intervention, 6 Months Post-intervention, 12 Months Post-intervention, 18 Months Post-intervention, 24 Months Post-interventionMeasured 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPearl McElfish, Phd, MDA

University of Arkansas

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026