No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
288 (estimated)
Sponsor
University of Arkansas · Other
Who this trial is looking for
This trial is looking for adults from the Marshall Islands with type 2 diabetes who want to improve their health. Participants will receive support and education for diabetes management along with a family member.
Are You a Good Fit for This Trial?
You may be able to join if
I am self-reported Marshallese
I am 18 years of age or older
I have been diagnosed with type 2 diabetes
I have at least one family member willing to take part in the study
You may not be able to join if
I have received diabetes self-management education in the past five years
I have a serious health condition that makes it unlikely I can follow the study requirements
I plan to move out of the area
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed 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, a…
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.
Trial Locations
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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 th…
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
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