Family Model DSME in FBOs in the RMI

Study Overview
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Brief Summary
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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.

Official Title
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Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Family Model Diabetes Self-Management Education and Support
* Behavioral: Family Model Diabetes Self-Management Education and Support (Wait-list)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Family model diabetes self-management education and support | Behavioral: Family Model Diabetes Self-Management Education and Support<br>* 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.<br>|
| Active Comparator: Wait-list Control<br>Family model diabetes self-management education and support | Behavioral: Family Model Diabetes Self-Management Education and Support (Wait-list)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention |