Project Dulce for Arab Americans With Type 2 Diabetes
ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorScripps Whittier Diabetes Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are a participant of Metro Caring
Self-identified Arab
Diagnosed with type 2 diabetes mellitus (T2DM)
HbA1c ≥7.5% in the last 30 days
Disqualifiers
Pregnant
Are currently participating in another diabetes-related study
Trial design
Design model
Single group
Treatments tested in this trial
Project Dulce + Dulce Digital
BehavioralProject 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.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Project Dulce + Dulce DigitalOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months2
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.
Time frame
6 months3
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.
Time frame
3 months4
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.
Time frame
6 monthsSecondary outcomes
1
Change in Baseline Summary of Diabetes Self-Care Activities at 3 months
Summary of Diabetes Self-Care Activities measure (Toobert, Hampson, \& Glassgow, 2000) is a 13-item brief questionnaire that assesses a respondent's adherence to self-management behavior recommendations in the past 7 days, including general and specific diet, exercise, blood glucose testing, foot care, medication adherence, and smoking, with greater scores indicating greater adherence.
Time frame
3 months2
Change in Baseline Summary of Diabetes Self-Care Activities at 6 months
Summary of Diabetes Self-Care Activities measure (Toobert, Hampson, \& Glassgow, 2000) is a 13-item brief questionnaire that assesses a respondent's adherence to self-management behavior recommendations in the past 7 days, including general and specific diet, exercise, blood glucose testing, foot care, medication adherence, and smoking, with greater scores indicating greater adherence.
Time frame
6 months3
Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months
International Physical Activity -Short Form (Craig et al., 2003) assesses the amount of physical activity (work, leisure, and other) and sedentary time in the past 7 days.
Time frame
3 months4
Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months
International Physical Activity -Short Form (Craig et al., 2003) assesses the amount of physical activity (work, leisure, and other) and sedentary time in the past 7 days.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Scripps Whittier Diabetes Institute
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Source ClinicalTrials.gov