Family Model DSME in FBOs in the RMI

University of Arkansas

Status

Enrolling

Conditions

Diabetes Mellitus, Type 2

Treatments

Behavioral: Family Model Diabetes Self-Management Education and Support

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

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05502016

263202

1R01DK128145-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

288 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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