Family Model Diabetes Self-Management Education in Faith Based Organizations

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAMS Institute for Community Health Innovation

Springdale, Arkansas, 72762, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Model Diabetes Self-Management Education and Support

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.

Primary outcomes

Glycemic Control, Measured by Change in Adjusted Mean HbA1c(%) From Baseline at various time points

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: FDSMEFBO

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Feb 5, 2020
Registry last updated: Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed