Clinical trial NCT05502016: Family Model DSME in FBOs in the RMI
Official title: Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-08-16
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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

Primary outcomes:
measure: Glycemic control, measured by change in mean HbA1c (%) from baseline
timeFrame: Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Springdale
country: United States
facility: UAMS Institute for Community Health Innovation
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Pearl McElfish, PhD
role: PRINCIPAL_INVESTIGATOR
References: