Project Dulce for Arab Americans With Type 2 Diabetes

Overview

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.

Interventions

• Behavioral Project Dulce + Dulce Digital
  Project Dulce is a 5-week curriculum, group diabetes self-management education and support, program delivered by a peer educator in Arabic. The curriculum provides knowledge as well as skills and tools needed to change behaviors and adapt to a life with type 2 diabetes. The curriculum covers diabetes and its complication, the role of diet, exercise, and medication, and the importance of self-monitoring as well as the genetics contribution to diabetes development. It is presented over 5 weeks w

Primary outcome measures

• Change from Baseline Diabetes Knowledge at 3 months [Time frame: 3 months]
• Change from Baseline Diabetes Knowledge at 6 months [Time frame: 6 months]
• Change from Baseline Health Belief Model Scale at 3 months [Time frame: 3 months]
• Change from Baseline Health Belief Model Scale at 6 months [Time frame: 6 months]
• Change in Baseline Self-Efficacy for Diabetes Scale at 3 months [Time frame: 3 months]
• Change in Baseline Self-Efficacy for Diabetes Scale at 6 months [Time frame: 6 months]
• Understanding Health Implications of Genomics at 3 months [Time frame: 3 months]
• Understanding Health Implications of Genomics at 6 months [Time frame: 6 months]

Secondary outcome measures (8)

• Change in Baseline Summary of Diabetes Self-Care Activities at 3 months [Time frame: 3 months]
• Change in Baseline Summary of Diabetes Self-Care Activities at 6 months [Time frame: 6 months]
• Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months [Time frame: 3 months]
• Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months [Time frame: 6 months]
• Change in Baseline Food Frequency Questionnaire at 3 months [Time frame: 3 months]
• Change in Baseline Food Frequency Questionnaire at 6 months [Time frame: 6 months]
• Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months [Time frame: 3 months]
• Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• San Ysidro Health — El Cajon
• Metro Caring — Denver

Identifiers

NCT: NCT05580536 · 22-7995

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗