Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Arkansas
- Enrollment
- 288
- Locations
- 1
- Primary Endpoint
- Glycemic control, measured by change in mean HbA1c (%) from baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Wait-list Control
Family model diabetes self-management education and support
Intervention: Family Model Diabetes Self-Management Education and Support (Wait-list) (Behavioral)
Intervention
Family model diabetes self-management education and support
Intervention: Family Model Diabetes Self-Management Education and Support (Behavioral)
Outcomes
Primary Outcomes
Glycemic control, measured by change in mean HbA1c (%) from baseline
Time Frame: 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 Outcomes
No secondary outcomes reported