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Diabetes Education for Type 2 Diabetes

N/A
Recruiting
Led By Pearl McElfish, PhD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with type 2 diabetes (HbA1c equal to or greater than 6.5%)
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediate post-intervention, 4 months post-intervention, 12 months post-intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether diabetes self-management education and support delivered in faith-based organizations by trained community health workers is effective in improving glycemic control for Marshallese people with type 2 diabetes.

Who is the study for?
This trial is for Marshallese adults with type 2 diabetes who have an HbA1c level of at least 6.5% and a family member to join them in the study. They shouldn't plan to move away, have conditions preventing protocol adherence, severe disabilities, or prior diabetes education within five years.
What is being tested?
The study tests a Family Model Diabetes Self-Management Education program delivered by community health workers in churches. Participants are randomly assigned to start immediately or wait (wait-list control), measuring effects on blood sugar control and other health indicators.
What are the potential side effects?
Since this intervention involves education and support rather than medication, typical drug side effects aren't expected. However, participants may experience stress or discomfort from lifestyle changes or frequent health monitoring required by the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have type 2 diabetes with an HbA1c of 6.5% or higher.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediate post-intervention, 4 months post-intervention, 12 months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediate post-intervention, 4 months post-intervention, 12 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Glycemic control, measured by change in mean HbA1c (%) from baseline

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Family model diabetes self-management education and support
Group II: Wait-list ControlActive Control1 Intervention
Family model diabetes self-management education and support

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,463 Previous Clinical Trials
4,337,115 Total Patients Enrolled
University of ArkansasLead Sponsor
496 Previous Clinical Trials
150,102 Total Patients Enrolled
Pearl McElfish, PhDPrincipal InvestigatorUniversity of Arkansas
3 Previous Clinical Trials
3,080 Total Patients Enrolled

Media Library

Family Model Diabetes Self-Management Education and Support Clinical Trial Eligibility Overview. Trial Name: NCT05502016 — N/A
Type 2 Diabetes Research Study Groups: Intervention, Wait-list Control
Type 2 Diabetes Clinical Trial 2023: Family Model Diabetes Self-Management Education and Support Highlights & Side Effects. Trial Name: NCT05502016 — N/A
Family Model Diabetes Self-Management Education and Support 2023 Treatment Timeline for Medical Study. Trial Name: NCT05502016 — N/A
~165 spots leftby Jan 2027