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NCT Number: NCT05502016

Family Model DSME in FBOs in the RMI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAMS Institute for Community Health Innovation

Springdale, Arkansas, 72764, United States

Location status: Recruiting

Location contact

Alix Montoya-Beltran

CONTACT

[email protected]

479-713-8000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Model Diabetes Self-Management Education and Support

Behavioral

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.

Primary outcomes

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Betsy O'Connor, MA

CONTACT

[email protected]

479-713-8000

Brett Rowland, MA

CONTACT

[email protected]

479-713-8000

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 16, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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