Family Model DSME in FBOs in the RMI

Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands

Health disparities in the Republic of the Marshall Islands are striking, with extremely high rates of type 2 diabetes. Documented prevalence of type 2 diabetes in the Marshall Islands ranges from 20%-50%.This is significantly higher than the global (8.5%) and United States (11%) prevalence. Diabetes doubles the risk of heart disease; is the leading cause of kidney failure, lower limb amputation, and acquired blindness; and reduces life expectancy by as much as 15 years. Diabetes self-management education and support is critical for persons with diabetes. This study aims to conduct a cluster-randomized controlled trial using a wait-list control to evaluate the effectiveness of family model diabetes self-management education and support when delivered in faith-based organizations (i.e., churches) in Marshallese by trained community health workers. The study will be conducted with up to 288 participants with type 2 diabetes and up to 288 of their family members. The primary study outcome will be glycemic control as measured by HbA1c. Secondary biometric measures include: fasting glucose, weight, body mass index, and blood pressure. Survey data will be collected pre-intervention, immediately post-intervention, four months post-intervention, and 12 months post-intervention for the intervention arm of the study. The control arm of the study will have two pre-intervention data collections before beginning the intervention. Data will then be collected from the control group immediately post-intervention, four months post-intervention, and 12 months post intervention.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Family Model Diabetes Self-Management Education and Support; Behavioral: Family Model Diabetes Self-Management Education and Support (Wait-list)

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brett Rowland, MA; Phone Number: 479-713-8000; Email: mbrowland@uams.edu
• Study Contact Backup: Name: Betsy O'Connor, MA; Phone Number: 479-713-8000; Email: geoconnor@uams.edu

Study Locations

• United States
  • Arkansas
    • Springdale, Arkansas, United States, 72764
      • Recruiting
      • UAMS Community Health and Research
      • Contact: Janine Boyers Schuh, MA; Phone Number: 479-713-8000; Email: jmboyersschuh@uams.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• self-reported Marshallese
• 18 years of age or older
• have type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%)
• have at least one family member willing to take part in the study

Exclusion Criteria:

• has received diabetes self-management education 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Family model diabetes self-management education and support	Behavioral: Family Model Diabetes Self-Management Education and Support; Participants assigned to this arm receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.
Active Comparator: Wait-list Control; Family model diabetes self-management education and support	Behavioral: Family Model Diabetes Self-Management Education and Support (Wait-list); Participants assigned to this arm will wait approximately 12 weeks to receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control, measured by change in mean HbA1c (%) from baseline	Point of care tests will be utilized to calculate HbA1c levels for each participant. The primary outcome measure is change in mean HbA1c (%) from baseline to immediate post-intervention, 4 months post-intervention, and 12 months post-intervention. Analyses will be adjusted for baseline HbA1c, sex, age, education, marital status, employment status, use of diabetes medications, and clustering of participants within churches.	Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Pearl McElfish, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 263202; 1R01DK128145-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No