Family Model DSME in FBOs in the RMI

N/ARecruitingNCT05502016

University of Arkansas288 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

288

Conditions

Interventions

Family Model Diabetes Self-Management Education and SupportBEHAVIORAL

Participants assigned to this arm receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.

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

Participants assigned to this arm will wait approximately 12 weeks to receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Glycemic control, measured by change in mean HbA1c (%) from baseline

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.

Time frame: Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention