Family Model Diabetes Self-Management Education in Faith Based Organizations

NCT04256486 | Completed

• 2 other identifiers: 2290341R01MD013852-01
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Family Model; Marshallese; Pacific Islander; Diabetes Education

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Family DSMES

EXPERIMENTAL

Behavioral: Family Model Diabetes Self-Management Education and Support

Wait List

EXPERIMENTAL

Behavioral: Family Model Diabetes Self-Management Education and Support

Interventions

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.

Family DSMES; Wait List

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-reported Marshallese
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

UAMS Institute for Community Health Innovation

Springdale, Arkansas, 72762, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pearl McElfish, Phd, MDA

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: April 21, 2022
• Primary Completion: May 22, 2025
• Study Completion: August 22, 2025
• Last Updated: November 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)