50 Participants Needed

Culturally Tailored Education for Type 2 Diabetes

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Overseen ByBeryl O'Donnell, MSN, RN, NP-C
Age: 18 - 65
Sex: Male
Trial Phase: Academic
Sponsor: Hackensack Meridian Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Diabetes mellitus (DM) is a global public health concern. In the United States, adult Hispanic males are particularly vulnerable to type 2 diabetes mellitus and are more likely to develop complications and subsequently die from it, compared to non-Hispanic White males. Evidence suggests good self-management behaviors can potentially prevent disease-related complications and improve clinical outcomes. The American Diabetes Association and Association of Diabetes Care and Education Specialists have endorsed diabetes self-management education as a necessary component of care for all individuals living with the disease. However, adult Hispanic males with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S., especially those who are underserved, typically lack access to formal diabetes self-management education (DSME). Further, the majority have never participated in such educational activities (Au et al., 2021; New Jersey Department of Health, 2013; 2017; 2023). A large body of evidence suggests DSME can effectively improve self-management behaviors in diverse populations around the globe (Abraham et al., 2020; Dietz et al., 2022; ElGerges, 2020; Gehlawat et al., 2019; Hailu et al., 2019; Jiang et al., 2022; Leong et al., 2022; Oluchina, 2022; Riangkam et al., 2022; Tamiru et al., 2023; Yu et al., 2022; Zheng et al., 2019). The purpose of the proposed study is to examine the effect of culturally tailored diabetes education on self-management behaviors of adult Hispanic males, aged 18-64 years, with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S. This study can shed more light on the effectiveness of community-based, culturally tailored diabetes educational activities in this vulnerable population and guide future efforts towards enhancing self-management.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Culturally Tailored Diabetes Education for Type 2 Diabetes?

Research shows that culturally tailored education can significantly improve self-care and diabetes-related health outcomes, such as A1C levels and weight loss, in minority populations, including African Americans with type 2 diabetes. These interventions are most effective when they incorporate cultural elements like language, location, and messaging.12345

Is culturally tailored diabetes education safe for humans?

The studies on culturally tailored diabetes education programs, such as HEAL-D and others, do not report any safety concerns, suggesting they are generally safe for human participants.16789

How is the Culturally Tailored Diabetes Education treatment different from other treatments for type 2 diabetes?

Culturally Tailored Diabetes Education is unique because it adapts diabetes education to fit the cultural values, language, and preferences of minority groups, making it more effective for these populations compared to standard education programs.124910

Research Team

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Beryl O'Donnell, MSN, RN, NP-C

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

This trial is for adult Hispanic males aged 18-64 in the Middle Atlantic Region of the U.S. with type 2 diabetes mellitus (T2DM). Participants must speak English or Spanish and not have severe kidney disease or terminal illnesses like cancer.

Inclusion Criteria

I speak English or Spanish.
I am a Hispanic male aged 18-64.
I have type 2 diabetes and no severe kidney disease or terminal illness.

Exclusion Criteria

I do not have type 2 diabetes.
I do not fall within the specified age range for the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Culturally Tailored Diabetes Education

Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7)

5 weeks
Weekly sessions

Follow-up

Participants are monitored for changes in self-management behaviors such as healthy eating, staying active, and medication use

4 weeks

Treatment Details

Interventions

  • Culturally Tailored Diabetes Education
Trial OverviewThe study tests culturally tailored diabetes self-management education to see if it improves how Hispanic males manage their type 2 diabetes, potentially preventing complications and enhancing clinical outcomes.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Culturally Tailored Diabetes EducationExperimental Treatment1 Intervention
Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials
141
Recruited
42,900+

References

Realist review to understand the efficacy of culturally appropriate diabetes education programmes. [2022]
Culturally tailored education for African Americans with type 2 diabetes. [2022]
Culturally tailored lifestyle interventions for the prevention and management of type 2 diabetes in adults of Black African ancestry: a systematic review of tailoring methods and their effectiveness. [2022]
Culturally Targeted Strategies for Diabetes Prevention in Minority Population. [2021]
Implementation and evaluation of a low health literacy and culturally sensitive diabetes education program. [2022]
Improved clinical outcomes using a culturally sensitive diabetes education program in a Hispanic population. [2022]
Teaching culturally effective diabetes care: results of a randomized controlled trial. [2019]
Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes. [2022]
Healthy Eating and Active Lifestyles for Diabetes (HEAL-D), a culturally tailored self-management education and support program for type 2 diabetes in black-British adults: a randomized controlled feasibility trial. [2023]
Development and Implementation of a Culturally Tailored Diabetes Intervention in Primary Care. [2021]