Family Model DSME in FBOs in the RMI

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05502016
• Other study ID #: 263202
• Secondary ID: 1R01DK128145-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: January 2027

Study information

• Verified date: March 2024
• Source: University of Arkansas
• Contact: Betsy O'Connor, MA
• Phone: 479-713-8000
• Email: geoconnor[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Family Model Diabetes Self-Management Education and Support
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)
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.

Locations

Country	Name	City	State
United States	UAMS Community Health and Research	Springdale	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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