Family-based diabetes education delivered through churches in the Marshall Islands

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for Marshallese adults with type 2 diabetes who have at least one family member willing to take part. It tests diabetes self-management education delivered in churches.

Age

18 years or older

Sex

All sexes can join.

Disease stage

Type 2 diabetes, defined as HbA1c of 6.5% (48 mmol/mol) or higher.

Earlier treatment

Cannot have received diabetes self-management education in the past five years.

Biomarker or test result

HbA1c equal to or greater than 6.5% (48 mmol/mol).

Main reasons for not taking part

• Received diabetes self-management education in the past five years
• A condition that makes it unlikely you can follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, or eating disorder
• Plans to move out of the geographic region

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• InterventionTreatment being tested

  Family model diabetes self-management education and support

  Treatment: Family Model Diabetes Self-Management Education and Support

• Wait-list ControlExisting treatment, for comparison

  Family model diabetes self-management education and support

  Treatment: Family Model Diabetes Self-Management Education and Support (Wait-list)