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Diabetes Mellitus, Type 2BehavioralBehavioral

What this study is

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.

What's being tested

  • Family Model Diabetes Self-Management Education and Support

    Intervention · 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.

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

    Intervention · 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.

Study details

Official title
Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands
Sponsor
University of Arkansas
Conditions
Diabetes Mellitus, Type 2
Enrolling
288 people
Starts
2023-06-30
Est. completion
2027-01-31
Design
Single-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗