Culturally Tailored Education for Type 2 Diabetes

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

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Hackensack Meridian Health

Disqualifiers: Severe kidney disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if culturally tailored diabetes education can help adult Hispanic males in the Middle Atlantic Region of the U.S. better manage type 2 diabetes. By focusing on self-management behaviors, the trial seeks to improve health outcomes in this group, who often lack access to such education. Participants will engage in a five-week educational program specifically designed for them. Hispanic males aged 18-64 with type 2 diabetes, without severe health conditions, and who speak English or Spanish, may find this trial suitable. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance diabetes management for their community.

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 prior data suggests that this education is safe for participants?

Research has shown that diabetes education tailored to different cultures is generally safe for patients. Studies have found that this type of education helps individuals control their blood sugar levels without causing harm. For instance, a program for Hispanic participants resulted in better health outcomes, such as lower blood sugar, without any negative side effects.

This education teaches people with diabetes how to manage their condition in a way that aligns with their culture and lifestyle. It is not a medicine or medical procedure, so there are no typical medical risks. Instead, it provides information and support to help manage diabetes effectively. Overall, evidence suggests that culturally tailored diabetes education is well-tolerated and beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Culturally Tailored Diabetes Education is unique because it adapts diabetes self-management strategies to fit the cultural context of individuals with type 2 diabetes. Unlike standard treatments that often use a one-size-fits-all approach, this method recognizes and incorporates cultural beliefs, dietary habits, and lifestyle practices into the education process. Researchers are excited about this approach because it has the potential to improve engagement and effectiveness by making the management of diabetes more relevant and personalized for diverse populations.

What evidence suggests that culturally tailored diabetes education is effective for type 2 diabetes?

Research has shown that diabetes education programs tailored to cultural needs effectively assist people with type 2 diabetes. These programs can improve blood sugar control, including lowering HbA1c (a measure of average blood sugar) and fasting glucose levels. One study found that HbA1c decreased by 4% and fasting glucose dropped by 19% after six months. This type of education surpasses standard programs by considering cultural needs and preferences, aiding better diabetes management. In this trial, participants will receive culturally tailored diabetes education, potentially serving as a powerful tool for Hispanic men with type 2 diabetes to improve their condition. ^{1 2 3 4 6}

Who Is on the Research Team?

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

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Culturally Tailored Diabetes Education

Trial Overview The 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.

How Is the Trial Designed?

Group I: Culturally Tailored Diabetes Education Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10759074/

Effectiveness of a culturally tailored diabetes education ... The primary outcomes are changes in haemoglobin A1c and CGM-derived metrics at 3 and 6 months. The secondary outcomes include participants' self ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1751991825000312

Factors influencing the uptake of culturally tailored ... This systematic review demonstrates that culturally tailored DSMES is more effective than standard diabetes education, resulting in better glycaemic control, ...

3. researchprotocols.org researchprotocols.org/2025/1/e71861

Culturally Tailored Diabetes Self-Management Education ... The primary aim of this trial is to evaluate the effectiveness of the HEAL-D intervention, compared to standard DSMES programs, on glycemic ...

4. bmcresnotes.biomedcentral.com bmcresnotes.biomedcentral.com/articles/10.1186/s13104-022-05937-0

Results from the first culturally tailored, multidisciplinary ... At the end of the study (6-month post-intervention), both HbA1c and fasting glucose decreased by 4% and 19%, respectively (Table 2). Regarding ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8883766/

Culturally tailored lifestyle interventions for the prevention and ... This evidence supports the effectiveness of culturally tailored lifestyle interventions for T2D management in populations of Black African ancestry.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7430876/

Impact of a Culturally Tailored Diabetes Education and ... A clinic-based culturally competent diabetes education/self-management program resulted in significant improvements in outcomes among Hispanic participants.