Trial Outcomes & Findings for Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus (NCT NCT06897618)

Last Updated: 2026-05-22

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

At baseline and right after the 5 week educational intervention

Results posted on

2026-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	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). 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).
Overall Study STARTED	40
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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). 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).
Overall Study Lost to Follow-up	9
Overall Study Incomplete survey	1

Baseline Characteristics

Race information on 3 participants is missing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Culturally Tailored Diabetes Education n=40 Participants Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7). 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).
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants n=40 Participants
Age, Categorical <=18 years	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=40 Participants
Sex: Female, Male Female	0 Participants n=40 Participants
Sex: Female, Male Male	40 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=40 Participants
Race/Ethnicity, Customized White	9 Participants n=37 Participants • Race information on 3 participants is missing
Race/Ethnicity, Customized Native American	1 Participants n=37 Participants • Race information on 3 participants is missing
Race/Ethnicity, Customized Prefer not to disclose	4 Participants n=37 Participants • Race information on 3 participants is missing
Race/Ethnicity, Customized Other race	23 Participants n=37 Participants • Race information on 3 participants is missing
Region of Enrollment United States	40 participants n=40 Participants

PRIMARY outcome

Timeframe: At baseline and right after the 5 week educational intervention

Population: Participants completing the post-survey are included

Outcome measures

Outcome measures
Measure	Culturally Tailored Diabetes Education n=30 Participants Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7). 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 Pre-intervention	3.75 score on a scale Interval 0.0 to 6.0
Healthy Eating Post-intervention	4.88 score on a scale Interval 0.25 to 7.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Culturally Tailored Diabetes Education n=30 Participants Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7). 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).
Staying Active Pre-intervention	2.25 score on a scale Interval 0.0 to 7.0
Staying Active Post-intervention	2.5 score on a scale Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Culturally Tailored Diabetes Education n=30 Participants Five weeks of culturally tailored diabetes self-management education modeled after Association of Diabetes Care and Education Seven-item Framework (ADCES7). 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).
Medication Use Post-intervention	7.00 score on a scale Interval 0.0 to 7.0
Medication Use Pre-intervention	7.00 score on a scale Interval 0.0 to 7.0

Adverse Events

Culturally Tailored Diabetes Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Beryl O'Donnell, RN, NPC, PhD

Hackensack Meridian Health

Phone: 7325704172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place