Project Dulce for Arab-Americans With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Project Dulce for Arab-Americans With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580536
• Other study ID #: 22-7995
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Scripps Whittier Diabetes Institute
• Contact: Ahmed Khattab, MD
• Phone: 8586787049
• Email: akhattab[@]scripps.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-identified Arab

• Diagnosed with type 2 diabetes mellitus (T2DM)

• Registered in the community clinic (or willing to register)

• HbA1c =8% within 1 month of screening

• Able to speak, read, write, and comprehend in English and Arabic

Exclusion Criteria:

• Severe illness precluding frequent visits to clinic

• Liver function tests (ALT and AST) > 3 times the upper limit of normal

• Body mass index = 23 kg/cm

• History of malignancy, except subjects who have been disease-free for > 5 years, or whose only malignancy has been basal or squamous cell skin carcinoma

• Creatinine > 3.5

• History of drug or alcohol abuse within 12 months prior to enrollment

• Not a permanent resident in the area

• Current enrollee in Project Dulce

• Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening

• Anemia

• Primary language other than English or Arabic

• Not willing to carry a mobile phone

• Type 1 or gestational diabetes

• Pregnant

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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 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.

Locations

Country	Name	City	State
United States	San Ysidro Health	El Cajon	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	3 months
Secondary	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.	6 months
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	Change in Baseline Food Frequency Questionnaire at 3 months	Food frequency questionnaire (Alqahtani et al., 2017) measures the amounts and frequencies of fruits, vegetables, and common foods in the Arab American community.	3 months
Secondary	Change in Baseline Food Frequency Questionnaire at 6 months	Food frequency questionnaire (Alqahtani et al., 2017) measures the amounts and frequencies of fruits, vegetables, and common foods in the Arab American community.	6 months
Secondary	Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months	Samples will be processed by Quest Diagnostics Inc and assayed by Immunoturbidimetry (Integra 800, Roche).	3 months
Secondary	Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months	Samples will be processed by Quest Diagnostics Inc and assayed by Immunoturbidimetry (Integra 800, Roche).	6 months