NCT05502016Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 288 (estimated)
- First submitted
- 12 Aug 2022
- Start date
- 30 Jun 2023
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- University of Arkansas
- Diseases
- Type 2 diabetes
- NCT number
- NCT05502016
What you commit to
- Study type: Interventional
- Planned participants: 288
- From 30 Jun 2023 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- has received diabetes self-management education in the past five years
Other illness
- 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
Other
- plans to move out of the geographic region
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UAMS Institute for Community Health Innovation Coordinator of this site? Confirm its status | Springdale | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.