Intervention for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UAMS Community Health and Research, Springdale, AR
Diabetes Mellitus, Type 2
Family Model Diabetes Self-Management Education and Support - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention

Month 12
Glycemic control, measured by change in mean HbA1c (%) from baseline

Trial Safety

Safety Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Trial Design

2 Treatment Groups

Wait-list Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment

288 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention · No Placebo Group · N/A

Intervention
Behavioral
Experimental Group · 1 Intervention: Family Model Diabetes Self-Management Education and Support · Intervention Types: Behavioral
Wait-list Control
Behavioral
ActiveComparator Group · 1 Intervention: Family Model Diabetes Self-Management Education and Support (Wait-list) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, immediate post-intervention, 4 months post-intervention, 12 months post-intervention
Closest Location: UAMS Community Health and Research · Springdale, AR
N/AFirst Recorded Clinical Trial
1 TrialsResearching Diabetes Mellitus, Type 2
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be willing to take part in the study.
You are eligible for the screening test if you are 18 years of age or older.
You have type 2 diabetes.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.