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NCT05502016 · ClinicalTrials.gov registry record · NA
Family Model DSME in FBOs in the RMI
A NA study of Diabetes Mellitus, Type 2, sponsored by University of Arkansas.
- Recruiting
- Registry status
- NA
- Development phase
- 288
- Enrollment target
- 1
- Study location
NCT05502016 is a NA study of Diabetes Mellitus, Type 2 that is actively recruiting participants, run by University of Arkansas. The registered enrollment target is 288 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05502016, a NA study of Diabetes Mellitus, Type 2, is actively recruiting participants, sponsored by University of Arkansas.
- RECRUITING
- Registry status
- NA
- Development phase
- 288 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Family Model Diabetes Self-Management Education and Support
- BEHAVIORAL Family Model Diabetes Self-Management Education and Support (Wait-list)
Study Locations (1)
Arkansas
- UAMS Institute for Community Health Innovation - Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2023-06-30 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05502016
The ClinicalTrials.gov registry entry for NCT05502016 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (94% lower). The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Family Model Diabetes Self-Management Education and Support is the first listed.
NCT05502016 reports 1 study location spanning 1 distinct geographic area - top geographies include Arkansas.
Frequently Asked Questions
What is clinical trial NCT05502016 about?
NCT05502016 is a clinical study titled "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...
What is the current status of trial NCT05502016?
This trial is currently recruiting. It is a NA study. The enrollment target is 288 participants. The study started on 2023-06-30. Estimated completion is 2027-01-31.
What conditions does trial NCT05502016 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT05502016?
The interventions under investigation include: Family Model Diabetes Self-Management Education and Support (BEHAVIORAL), Family Model Diabetes Self-Management Education and Support (Wait-list) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05502016?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05502016 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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