Family Model DSME in FBOs in the RMI
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 Start (Actual) 30 June 2023
🗓️ Primary Completion (Estimated) January 2027
✅ Study Completion (Estimated) January 2027
👥 Enrollment (Estimated) 288
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Springdale, Arkansas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 August 2022
  • First Submitted that Met QC Criteria 12 August 2022
  • First Posted 16 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 March 2024
  • Last Update Posted 7 March 2024
  • Last Verified March 2024