Family Model DSME in FBOs in the RMI
University of Arkansas · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05502016
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 288
- US sites recruiting
- 1
- Study start
- June 30, 2023
- Record last updated
- December 8, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Family Model Diabetes Self-Management Education and Support; Family Model Diabetes Self-Management Education and Support (Wait-list)
Conditions: Diabetes Mellitus, Type 2
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
UAMS Institute for Community Health Innovation
Springdale, AR 72764
Site contact: Alix Montoya-Beltran · 479-713-8000 · amontoyabeltran@uams.edu
Study contacts (from the official record)
- Betsy O'Connor, MA · 479-713-8000 · geoconnor@uams.edu
- Brett Rowland, MA · 479-713-8000 · mbrowland@uams.edu
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