Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus

NCT ID: NCT06897618

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-12
• Study Completion Date: 2026-09-11

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Culturally tailored diabetes self-management education

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Outside the age range listed above
• Without a diagnosis of type 2 diabetes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

Hackensack Meridian Health, JFK University Medical

Plainfield, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

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

Role: CONTACT

beryl.odonnell@hmhn.org

732-570-4172

Facility Contacts

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

Role: primary

beryl.odonnell@hmhn.org

732-570-4172

Other Identifiers

Pro2025-0124

Identifier Type: -

Identifier Source: org_study_id