Family Model DSME in FBOs in the RMI

NCT ID: NCT05502016

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2027-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention

Family model diabetes self-management education and support

Group Type: EXPERIMENTAL

Family Model Diabetes Self-Management Education and Support

Intervention Type: 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.

Wait-list Control

Family model diabetes self-management education and support

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pearl McElfish, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

UAMS Institute for Community Health Innovation

Springdale, Arkansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Betsy O'Connor, MA

Role: CONTACT

geoconnor@uams.edu

479-713-8000

Brett Rowland, MA

Role: CONTACT

mbrowland@uams.edu

479-713-8000

Facility Contacts

Alix Montoya-Beltran

Role: primary

amontoyabeltran@uams.edu

479-713-8000

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DK128145-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

263202

Identifier Type: -

Identifier Source: org_study_id