Family Model DSME in FBOs in the RMI

NCT05502016 | Recruiting

• 2 other identifiers: 2632021R01DK128145-01A1
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Family model diabetes self-management education and support

Behavioral: Family Model Diabetes Self-Management Education and Support

Wait-list Control

ACTIVE COMPARATOR

Family model diabetes self-management education and support

Behavioral: Family Model Diabetes Self-Management Education and Support (Wait-list)

Interventions

Family Model Diabetes Self-Management Education and Support BEHAVIORAL

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.

Intervention

Family Model Diabetes Self-Management Education and Support (Wait-list) BEHAVIORAL

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.

Wait-list Control

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UAMS Institute for Community Health Innovation

Springdale, Arkansas, 72764, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Palliative Care; Waiting Lists

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; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Pearl McElfish, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betsy O'Connor, MA

CONTACT

479-713-8000; geoconnor@uams.edu

Brett Rowland, MA

CONTACT

479-713-8000; mbrowland@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 16, 2022
• Study Start: June 30, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (1)