UAMS Institute for Community Health Innovation
Springdale, Arkansas, 72764, United States
Location status: Recruiting
NCT Number: NCT05502016
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Springdale, Arkansas, 72764, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Betsy O'Connor, MA
CONTACT
Brett Rowland, MA
CONTACT
University of Arkansas
Other
Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands
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.
Published trials that share one or more normalized conditions with this study.
NCT07532863
Diabetes Mellitus, Diabetes Mellitus, Type 2
Tangerang, Banten, Indonesia
View Trial DetailsNCT05962372
Abdominal Obesity, Body Weight
San Juan, Puerto Rico
View Trial DetailsNCT07215559
Body Weight, Diabetes Mellitus
Gilbert, Arizona, United States
View Trial DetailsNCT05681468
Body Weight, Diabetes Mellitus
Edmonton, Alberta, Canada
View Trial Details