Clinical trial NCT06897618: Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus
Official title: Effect of Culturally Tailored Diabetes Education on Self-Management Behaviors of Adult Hispanic Males With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Diabete Type 2
Keywords: Type 2 diabetes
Self-Management Behaviors
Culturally Tailored Diabetes Education
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 (Au et al., 2021; New Jersey Department of Health, 2013; 2017; 2023). A large body of evidence suggests DSME can effectively improve self-management behaviors in diverse populations around the globe (Abraham et al., 2020; Dietz et al., 2022; ElGerges, 2020; Gehlawat et al., 2019; Hailu et al., 2019; Jiang et al., 2022; Leong et al., 2022; Oluchina, 2022; Riangkam et al., 2022; Tamiru et al., 2023; Yu et al., 2022; Zheng et al., 2019). 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.


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

Primary outcomes:
measure: Healthy Eating
timeFrame: At baseline and right after the 5 week educational intervention
measure: Staying Active
timeFrame: At baseline and right after the 5 week educational intervention
measure: Medication Use
timeFrame: At baseline and right after the 5 week educational intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Plainfield
country: United States
facility: Hackensack Meridian Health, JFK University Medical
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Beryl O'Donnell, MSN, RN, NP-C
role: PRINCIPAL_INVESTIGATOR
References: