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Family Model DSME in FBOs in the RMI

University of Arkansas · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05502016

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
288
US sites recruiting
1
Study start
June 30, 2023
Record last updated
December 8, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is 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.

Being studied: Family Model Diabetes Self-Management Education and Support; Family Model Diabetes Self-Management Education and Support (Wait-list)

Conditions: Diabetes Mellitus, Type 2

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • UAMS Institute for Community Health Innovation

    Springdale, AR 72764

    Site contact: Alix Montoya-Beltran · 479-713-8000 · amontoyabeltran@uams.edu

Study contacts (from the official record)

  • Betsy O'Connor, MA · 479-713-8000 · geoconnor@uams.edu
  • Brett Rowland, MA · 479-713-8000 · mbrowland@uams.edu
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Family Model DSME in FBOs in the RMI (NCT05502016) | Bored Studies