An interventional study of Culturally tailored diabetes self-management education in Diabetes Mellitus and Diabete Type 2, sponsored by Hackensack Meridian Health. Terminated at 1 site in United States. Open to male participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Hackensack Meridian Health · Not applicable, Interventional, and Supportive care
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hackensack Meridian Health is the lead sponsor of 111 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 11 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7).
Behavioral: Culturally tailored diabetes self-management education
Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7).
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
Time frame: 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
Time frame: 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
Time frame: At baseline and right after the 5 week educational intervention
| Milestone | Culturally Tailored Diabetes Education |
|---|---|
| Started | 40 |
| Completed | 30 |
| Not completed | 10 |
| Withdrew: Lost to follow-up | 9 |
| Withdrew: Incomplete survey | 1 |
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
| score on a scale | Culturally Tailored Diabetes Education |
|---|---|
| Pre-intervention | 3.75 (0 to 6.00) |
| Post-intervention | 4.88 (0.250 to 7.00) |
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
| score on a scale | Culturally Tailored Diabetes Education |
|---|---|
| Pre-intervention | 2.25 (0 to 7.00) |
| Post-intervention | 2.5 (0 to 7.00) |
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
| score on a scale | Culturally Tailored Diabetes Education |
|---|---|
| Pre-intervention | 7.00 (0 to 7.00) |
| Post-intervention | 7.00 (0 to 7.00) |
Collected over through study completion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Culturally Tailored Diabetes Education | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
Enrolled participants
| Age, Categorical(Participants) | Culturally Tailored Diabetes Education |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 40 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Culturally Tailored Diabetes Education |
|---|---|
| Female | 0 |
| Male | 40 |
| Ethnicity (NIH/OMB)(Participants) | Culturally Tailored Diabetes Education |
|---|---|
| Hispanic or Latino | 36 |
| Not Hispanic or Latino | 1 |
| Unknown or Not Reported | 3 |
| Race/Ethnicity, Customized(Participants) | Culturally Tailored Diabetes Education |
|---|---|
| White | 9 |
| Native American | 1 |
| Prefer not to disclose | 4 |
| Other race | 23 |
| Region of Enrollment(participants) | Culturally Tailored Diabetes Education |
|---|---|
| United States | 40 |
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Hackensack Meridian Health