Actively Recruiting
Family Model DSME in FBOs in the RMI
Led by University of Arkansas · Updated on 2025-12-08
288
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
Sponsors
U
University of Arkansas
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Family Model DSME in FBOs in the RMI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-reported Marshallese
- 18 years of age or older
- Have type 2 diabetes with HbA1c equal to or greater than 6.5%
- Have at least one family member willing to participate in the study
You will not qualify if you...
- Received diabetes self-management education in the past five years
- Have a condition likely to prevent following the study protocol, such as terminal illness, non-ambulatory status, severe mental illness, severely impaired vision or hearing, or eating disorder
- Plan to move out of the geographic region during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UAMS Institute for Community Health Innovation
Springdale, Arkansas, United States, 72764
Actively Recruiting
Research Team
B
Betsy O'Connor, MA
CONTACT
B
Brett Rowland, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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