Family Model DSME in FBOs in the RMI
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Family Model Diabetes Self-Management Education and Support (Wait-list)Behavioral: Family Model Diabetes Self-Management Education and Support
- Registration Number
- NCT05502016
- Lead Sponsor
- University of Arkansas
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 288
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wait-list Control Family Model Diabetes Self-Management Education and Support (Wait-list) Family model diabetes self-management education and support Intervention Family Model Diabetes Self-Management Education and Support Family model diabetes self-management education and support
- Primary Outcome Measures
Name Time Method Glycemic control, measured by change in mean HbA1c (%) from baseline Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention Point of care tests will be utilized to calculate HbA1c levels for each participant. The primary outcome measure is change in mean HbA1c (%) from baseline to immediate post-intervention, 4 months post-intervention, and 12 months post-intervention. Analyses will be adjusted for baseline HbA1c, sex, age, education, marital status, employment status, use of diabetes medications, and clustering of participants within churches.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UAMS Institute for Community Health Innovation
🇺🇸Springdale, Arkansas, United States