288 Participants Needed

Diabetes Education for Type 2 Diabetes

Recruiting at 1 trial location
BO
BR
Overseen ByBrett Rowland, MA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Arkansas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on diabetes education and support, so it's likely you can continue your current treatment, but you should confirm with the trial organizers.

What data supports the effectiveness of the treatment Family Model Diabetes Self-Management Education and Support for Type 2 Diabetes?

Research shows that diabetes self-management education and support (DSMES) programs, especially those involving family members, can improve diabetes-related outcomes for patients. Engaging family members in these programs may enhance the health benefits for both patients and their families.12345

Is the Family Model Diabetes Self-Management Education and Support safe for humans?

The available research does not provide specific safety data for the Family Model Diabetes Self-Management Education and Support, but these programs generally focus on education and lifestyle changes, which are typically safe for participants.23467

How is the Family Model DSME treatment different from other treatments for type 2 diabetes?

The Family Model DSME treatment is unique because it involves the patient's family in the diabetes education process, which can improve outcomes for both the patient and their family members by promoting healthy lifestyle changes together.23489

What is the purpose of this trial?

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.

Research Team

PM

Pearl McElfish, PhD

Principal Investigator

University of Arkansas

Eligibility Criteria

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.

Inclusion Criteria

I have type 2 diabetes with an HbA1c of 6.5% or higher.
You are of Marshallese descent.
Have at least one family member willing to take part in the study

Exclusion Criteria

I have received diabetes education in the last 5 years.
I am able to follow the study's requirements without major health or sensory issues.
Plans to move out of the geographic region

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention

Survey data collected pre-intervention for both intervention and control groups

2 weeks
1 visit (in-person)

Intervention

Family model diabetes self-management education and support delivered in faith-based organizations

12 weeks
Weekly sessions (in-person)

Post-Intervention Follow-up

Survey data collected immediately post-intervention, 4 months post-intervention, and 12 months post-intervention

12 months
3 visits (in-person)

Treatment Details

Interventions

  • Family Model Diabetes Self-Management Education and Support
  • Family Model Diabetes Self-Management Education and Support (Wait-list)
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials
500
Recruited
153,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

The study aims to compare the effectiveness of Family-DSMES, which involves family members in diabetes self-management education, against Standard-DSMES for individuals with type 2 diabetes, involving participants aged 18 and older with a hemoglobin A1c of 7.0% or higher.
Data will be collected at multiple time points (baseline, post-intervention, and at 6, 12, and 18 months) to assess various outcomes, including the primary outcome of hemoglobin A1c levels, and to evaluate the impact on both the person with diabetes and their family members.
Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model.Mayberry, LS., Felix, HC., Hudson, J., et al.[2023]
In a study involving Marshallese adults with Type 2 diabetes, family members who attended diabetes self-management education (DSME) sessions did not show significant improvements in A1c levels, BMI, food consumption, or physical activity compared to those who did not attend, indicating low engagement and effectiveness of the program for families.
The only significant predictor of having a normal A1c level after 12 months was a reduction in BMI, suggesting that while family DSME may not have directly benefited family members, weight management could be crucial for diabetes prevention.
Effects of a family diabetes self-management education intervention on the patients' supporters.Felix, HC., Narcisse, MR., Long, CR., et al.[2023]
The study identified five key attributes of effective diabetes self-management education (DSME) interventions for individuals with type 2 diabetes, categorized into skills-related (decision making, problem solving, taking action) and information-related attributes (patient-provider interaction, resource utilization).
By clarifying these attributes, the research provides a measurable framework for designing and implementing DSME interventions, which can enhance the effectiveness of diabetes management programs.
Towards a better understanding of self-management interventions in type 2 diabetes: A concept analysis.Othman, MM., Khudadad, H., Dughmosh, R., et al.[2022]

References

Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. [2023]
Effects of a family diabetes self-management education intervention on the patients' supporters. [2023]
Towards a better understanding of self-management interventions in type 2 diabetes: A concept analysis. [2022]
Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis. [2022]
Insights From the National Diabetes Education Program National Diabetes Survey: Opportunities for Diabetes Self-Management Education and Support. [2020]
Diabetes education: looking through the kaleidoscope. [2013]
Self-management Education in Type 2 Diabetes in Primary Care. [2021]
Quick guide to type 2 diabetes self-management education: creating an interdisciplinary diabetes management team. [2020]
Diabetes knowledge and glycemic control among Chinese people with type 2 diabetes. [2022]
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