Clinical trial NCT05580536: Project Dulce for Arab Americans With Type 2 Diabetes
Official title: Project Dulce for Arab Americans With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Diabetes Self-Care
DSME
Genetic Education
Community Education
Arab Americans
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-10-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Arab Americans (AA) face many challenges in diabetes self-management due to the limited educational resources and support available for them. The cultural and linguistic barriers between patients and health care providers lead to poor diabetes management and outcomes. This study (Project Dulce Arabic) is adapted from the Project Dulce, an American Diabetes Association (ADA)-recognized Diabetes Self-Management Education Support (DSMES) program. Project Dulce Arabic comprises both peer-led diabetes education in Arabic and a 3-month text messaging program (Dulce Digital). The main aim of the study is to examine the effectiveness of a more culturally and linguistically appropriate diabetes education program in improving diabetes knowledge, beliefs, and self-management as well as hemoglobin A1C.

Detailed description: Although the Arab American (AA) population is at a higher risk of pre-diabetes and type 2 diabetes (T2D) compared to the white non-Hispanic population, there are hardly any culturally appropriate diabetes self-management resources available for Arab Americans.

Project Dulce Arabic is a pilot study addressing both the linguistic and cultural barriers faced by the AA community in diabetes self-management while exploring the genetic background of type 2 diabetes in Arab Americans. To overcome the linguistic barriers, we adapt educational materials from the Project Dulce diabetes self-management study of Mexican Americans (A. Philis-Tsimikas et al., 2011). This 5-week peer-led educational program in Arabic aims to enhance type 2 diabetes knowledge, beliefs, and self-management behaviors as well as improving diabetes management measured by hemoglobin A1C after 3 months and 6 months in the study.

Project Dulce Arabic is incorporating genetic education as a part of its curriculum to raise the community awareness of the role of genetics in T2D development as well as the importance of early genetic risk detection for T2D prevention. We are also asking our Project Dulce Arabic participants to participate in the Scripps Bio-Repository (https://www.scripps.org/research/bio-repository). The specimens obtained from our study cohort will be used for genetic sequencing. Obtaining this genetic information will enable us to gain more insights into the genetic basis of type 2 diabetes in Arab Americans. Comparing the genetic risk of T2D, available from different biobanks, in other ethnic groups with that in Arab Americans would highlight the disease risk faced by the community and draw more attention towards the importance of early disease detection and prevention through tailored screening recommendations.

Eligibility criteria: Inclusion Criteria:

* Are a participant of Metro Caring
* Self-identified Arab
* Diagnosed with type 2 diabetes mellitus (T2DM)
* HbA1c ≥7.5% in the last 30 days
* Able to speak, read, write, and comprehend in English and Arabic
* Have access to a cell phone that can receive/send text messages throughout the study

Exclusion Criteria:

* Pregnant
* Are currently participating in another diabetes-related study

Primary outcomes:
measure: Change from Baseline Diabetes Knowledge at 3 months
timeFrame: 3 months
measure: Change from Baseline Diabetes Knowledge at 6 months
timeFrame: 6 months
measure: Change from Baseline Health Belief Model Scale at 3 months
timeFrame: 3 months
measure: Change from Baseline Health Belief Model Scale at 6 months
timeFrame: 6 months
measure: Change in Baseline Self-Efficacy for Diabetes Scale at 3 months
timeFrame: 3 months
measure: Change in Baseline Self-Efficacy for Diabetes Scale at 6 months
timeFrame: 6 months
measure: Understanding Health Implications of Genomics at 3 months
timeFrame: 3 months
measure: Understanding Health Implications of Genomics at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in Baseline Summary of Diabetes Self-Care Activities at 3 months
timeFrame: 3 months
measure: Change in Baseline Summary of Diabetes Self-Care Activities at 6 months
timeFrame: 6 months
measure: Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months
timeFrame: 3 months
measure: Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months
timeFrame: 6 months
measure: Change in Baseline Food Frequency Questionnaire at 3 months
timeFrame: 3 months
measure: Change in Baseline Food Frequency Questionnaire at 6 months
timeFrame: 6 months
measure: Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
timeFrame: 3 months
measure: Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: El Cajon
country: United States
facility: San Ysidro Health
state: California
city: Denver
country: United States
facility: Metro Caring
state: Colorado
Study officials:
affiliation: Scripps
name: Ahmed Khattab, MD
role: PRINCIPAL_INVESTIGATOR
References: