Diabetes MellitusNCT06897618
Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus
A study testing Culturally tailored diabetes self-management education in people with Diabetes Mellitus and Diabete Type 2, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Diabetes Mellitus, Diabete Type 2
- What is being tested?
- Culturally tailored diabetes self-management education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2025to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age: Adult Hispanic males 18-64 at time of study intervention.
- Diagnosis Codes: Patients with self-reported diagnosis of T2DM without complex, co-morbid conditions such as severe kidney disease and terminal illnesses such as cancer.
- English or Spanish speaking
Who cannot join
- Outside the age range listed above
- Without a diagnosis of type 2 diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack Meridian Health, JFK University Medical
Plainfield, New Jersey, 07060
About this study
Official title: Effect of Culturally Tailored Diabetes Education on Self-Management Behaviors of Adult Hispanic Males With Type 2 Diabetes Mellitus
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. A large body of evidence suggests DSME can effectively improve self-management behaviors in diverse populations around the globe. 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.
- Conditions
- Diabetes Mellitus, Diabete Type 2
- Being tested
- Culturally tailored diabetes self-management education
- Keywords
- Type 2 diabetes, Self-Management Behaviors, Culturally Tailored Diabetes Education
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally tailored diabetes self-management educationBehavioural
Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7).
| Study group | Role | What they receive |
|---|---|---|
| Culturally Tailored Diabetes Education | Experimental | Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7). Receives: Behavioral: Culturally tailored diabetes self-management education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Eating
Healthy eating behaviors will be measured by self-reported data on diet adherence utilizing scoring derived from the Spanish version of the Summary of Diabetes Self-Care Assessment (SDSCA) scale. Items 1-5 relate to dietary behaviors, for example, "how many of the last seven days have you followed a healthful eating plan?" Diet will be scored using the mean number of days for items 1-5, using a reverse score for item 4. Scores range from 0 to 7 with higher numbers corresponding to higher levels of self-care activity performance
Measured: At baseline and right after the 5 week educational intervention
Staying Active
Physical activity behaviors will be measured by self-reported data on exercise adherence utilizing scoring derived from the Spanish version of the Summary of Diabetes Self-Care Assessment (SDSCA) scale. Items 6-7 pertain to exercise activity, for example, "on how many of the last seven days did you participate in at least 30 minutes of physical activity?" Exercise will be scored using the mean number of days for items 6 and 7. Scores range from 0 to 7 with higher numbers corresponding to higher levels of self-care activity performance
Measured: At baseline and right after the 5 week educational intervention
Medication Use
Medication use behaviors will be measured by self-reported data on medication adherence utilizing scoring derived from the Spanish version of the Summary of Diabetes Self-Care Assessment (SDSCA) scale. Medication use will be scored using total number of days for item 12. Scores range from 0 to 7 with higher numbers corresponding to higher levels of self-care activity performance
Measured: At baseline and right after the 5 week educational intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start12 Sep 2025
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Why it stopped: recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beryl O'Donnell, MSN, RN, NP-C, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897618
- Sponsor's protocol ID
- Pro2025-0124
- Status last verified
- May 2026
- First submitted
- 20 Mar 2025
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Culturally Tailored Diabetes Education on Self-Management Behaviors of Adult Hispanic Males With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06897618
- Acronym / sponsor ID
- Pro2025-0124
- Conditions
- Diabetes Mellitus, Diabete Type 2
- Keywords
- Type 2 diabetes, Self-Management Behaviors, Culturally Tailored Diabetes Education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment challenges
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. A large body of evidence suggests DSME can effectively improve self-management behaviors in diverse populations around the globe. 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Culturally Tailored Diabetes Education | Experimental | Behavioral: Culturally tailored diabetes self-management educationFive weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: Adult Hispanic males 18-64 at time of study intervention.
- Diagnosis Codes: Patients with self-reported diagnosis of T2DM without complex, co-morbid conditions such as severe kidney disease and terminal illnesses such as cancer.
- English or Spanish speaking
Key exclusion criteria (2 listed)
- Outside the age range listed above
- Without a diagnosis of type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally tailored diabetes self-management educationFive weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7). | Behavioural | Culturally Tailored Diabetes Education |
Primary outcome
Healthy Eating
Time frame: At baseline and right after the 5 week educational intervention
Healthy eating behaviors will be measured by self-reported data on diet adherence utilizing scoring derived from the Spanish version of the Summary of Diabetes Self-Care Assessment (SDSCA) scale. Items 1-5 relate to dietary behaviors, for example, "how many of the last seven days have you followed a healthful eating plan?" Diet will be scored using the mean number of days for items 1-5, using a reverse score for item 4. Scores range from 0 to 7 with higher numbers corresponding to higher levels of self-care activity performance
Staying Active
Time frame: At baseline and right after the 5 week educational intervention
Physical activity behaviors will be measured by self-reported data on exercise adherence utilizing scoring derived from the Spanish version of the Summary of Diabetes Self-Care Assessment (SDSCA) scale. Items 6-7 pertain to exercise activity, for example, "on how many of the last seven days did you participate in at least 30 minutes of physical activity?" Exercise will be scored using the mean number of days for items 6 and 7. Scores range from 0 to 7 with higher numbers corresponding to higher levels of self-care activity performance
Medication Use
Time frame: At baseline and right after the 5 week educational intervention
Medication use behaviors will be measured by self-reported data on medication adherence utilizing scoring derived from the Spanish version of the Summary of Diabetes Self-Care Assessment (SDSCA) scale. Medication use will be scored using total number of days for item 12. Scores range from 0 to 7 with higher numbers corresponding to higher levels of self-care activity performance
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beryl O'Donnell, MSN, RN, NP-C principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally tailored diabetes self-management education in people with Diabetes Mellitus and Diabete Type 2, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Eating (time frame: At baseline and right after the 5 week educational intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.