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NCT05502016NARecruitingAccepts Healthy Volunteers

Family Model DSME in FBOs in the RMI

University of Arkansas

Start Date

6/30/2023

Completion Date

1/31/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Family Model Diabetes Self-Management Education and Support

BEHAVIORAL

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

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Conditions

Diabetes Mellitus, Type 2

Locations

UAMS Institute for Community Health Innovation

Springdale, Arkansas 72764

United States