Family Model DSME in FBOs in the RMI

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
University of Arkansas
Study ID
NCT05502016
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2023
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
288 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention
    Family model diabetes self-management education and support
  • Active Comparator: Wait-list Control
    Family model diabetes self-management education and support

Primary Outcome Measure

Glycemic control, measured by change in mean HbA1c (%) from baseline [ Time Frame: Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UAMS Institute for Community Health InnovationSpringdaleArkansas72764
Alix Montoya-Beltran
[email protected]
479-713-8000

Find similar trials in Springdale, AR

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
UAMS Institute for Community Health Innovation· Springdale, AR

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