Recruiting

Family Model DSME

Sponsor:

University of Arkansas

Code:

NCT05502016

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Family Model Diabetes Self-Management Education and Support

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

Study Details

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 ID

NCT05502016

Start date

Jun 30, 2023

Status verified date

Dec, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

288 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention

Family model diabetes self-management education and support

active comparator: Wait-list Control

Family model diabetes self-management education and support

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.

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.

Primary outcome measure

  • Glycemic control, measured by change in mean HbA1c (%) from baseline [ Time Frame: Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention ]

Central Contacts and Locations

Central contacts

Locations

UAMS Institute for Community Health Innovation

Recruiting

Springdale, Arkansas, United States, 72764

Contacts

More Information

Sponsor

University of Arkansas

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2025-12-08.