Project Dulce for Arab Americans With Type 2 Diabetes

NCT05580536 | Recruiting

• 1 other identifier: 22-7995
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Diabetes Self-Care; DSME; Genetic Education; Community Education; Arab Americans

Outcome Measures

Primary Outcomes (8)

• Change from Baseline Diabetes Knowledge at 3 months

  Diabetes Knowledge Test (Diabetes Research and Training Center, University of Michigan, 2015) is a 23-item measure of diabetes knowledge, with general questions related to symptoms, self-management (e.g., diet, exercise, foot care, blood glucose monitoring, insulin), and complications (e.g., low, and high blood sugar). Greater scores indicate greater diabetes knowledge.

  3 months

• Change from Baseline Diabetes Knowledge at 6 months

  Diabetes Knowledge Test (Diabetes Research and Training Center, University of Michigan, 2015) is a 23-item measure of diabetes knowledge, with general questions related to symptoms, self-management (e.g., diet, exercise, foot care, blood glucose monitoring, insulin), and complications (e.g., low, and high blood sugar). Greater scores indicate greater diabetes knowledge.

  6 months

• Change from Baseline Health Belief Model Scale at 3 months

  Health Belief Model scale (Tan, 2004) is comprised of 36 items that evaluate the health beliefs and attitudes about complications prevention behaviors and active health related behaviors in individuals with diabetes. Responses are on a 5-point Likert-type scale (1=strongly disagree, 5=strongly agree), with lower scores indicating greater negative beliefs.

  3 months

• Change from Baseline Health Belief Model Scale at 6 months

  Health Belief Model scale (Tan, 2004) is comprised of 36 items that evaluate the health beliefs and attitudes about complications prevention behaviors and active health related behaviors in individuals with diabetes. Responses are on a 5-point Likert-type scale (1=strongly disagree, 5=strongly agree), with lower scores indicating greater negative beliefs.

  6 months

• Change in Baseline Self-Efficacy for Diabetes Scale at 3 months

  Stanford Self-Efficacy for Diabetes Scale (Lorig, Stewart, Ritter, et al., 1996) is comprised of 8 items that measure the confidence of a participant in performing self-care activities such as eating meals every 4 to 5 hours, following a healthful diet, exercising, and blood glucose monitoring. Response options range from 1=not at all confident to 10=totally confident, with higher scores indicating greater self-efficacy.

  3 months

• Change in Baseline Self-Efficacy for Diabetes Scale at 6 months

  Stanford Self-Efficacy for Diabetes Scale (Lorig, Stewart, Ritter, et al., 1996) is comprised of 8 items that measure the confidence of a participant in performing self-care activities such as eating meals every 4 to 5 hours, following a healthful diet, exercising, and blood glucose monitoring. Response options range from 1=not at all confident to 10=totally confident, with higher scores indicating greater self-efficacy.

  6 months

• Understanding Health Implications of Genomics at 3 months

  To assess the genetic knowledge, a 12-items questionnaire. Response options are 'agree', 'disagree', or 'don't know'. Similarly, a 13-items questionnaire with response options of 'agree' or 'disagree' will be used to assess the attitudes toward genetics research and testing.

  3 months

• Understanding Health Implications of Genomics at 6 months

  To assess the genetic knowledge, a 12-item questionnaire. Response options are 'agree', 'disagree', or 'don't know'. Similarly, a 13-item questionnaire with response options of 'agree' or 'disagree' will be used to assess the attitudes toward genetics research and testing.

  6 months

Secondary Outcomes (8)

• Change in Baseline Summary of Diabetes Self-Care Activities at 3 months

  3 months

• Change in Baseline Summary of Diabetes Self-Care Activities at 6 months

  6 months

• Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months

  3 months

• Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months

  6 months

• Change in Baseline Food Frequency Questionnaire at 3 months

  3 months

Study Arms (1)

Project Dulce + Dulce Digital

OTHER

Participants will participate in a peer-led group diabetes self-management education and support program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes.

Behavioral: Project Dulce + Dulce Digital

Interventions

Project Dulce + Dulce Digital BEHAVIORAL

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 where participants will learn and practice diabetes self-management skills, and help one another address family, cultural, or health system barriers to managing their diabetes. . Following the 5-week curriculum, participants will be enrolled in the digital texting platform, Dulce Digital, in which they will receive on-going support via text messages derived from the curriculum, medication reminders, and blood glucose monitoring prompts in Arabic.

Project Dulce + Dulce Digital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Scripps Whittier Diabetes Institute: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (2)

San Ysidro Health

El Cajon, California, 92020, United States

COMPLETED

Metro Caring

Denver, Colorado, 80218, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Health Education

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ahmed Khattab, MD

  Scripps

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Khattab, MD

CONTACT

8586782129; akhattab@scripps.edu

Lannea Hand, MS, RDN

CONTACT

720-860-7200; LHand@metrocaring.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: February 17, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)