- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05580536
Project Dulce for Arab-Americans With Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Khattab, MD
- Phone Number: 8586787049
- Email: akhattab@scripps.edu
Study Locations
-
-
California
-
El Cajon, California, United States, 92020
- Recruiting
- San Ysidro Health
-
Contact:
- Ahmed Khattab, MD
- Phone Number: 858-678-7049
- Email: akhattab@scripps.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Project Dulce + Dulce Digital
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Baseline Self-Efficacy for Diabetes Scale at 3 months
Time Frame: 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
Time Frame: 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
|
Change from Baseline Diabetes Knowledge at 3 months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Understanding Health Implications of Genomics at 3 months
Time Frame: 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
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months
Time Frame: 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
|
Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months
Time Frame: 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
|
Change in Baseline Summary of Diabetes Self-Care Activities at 3 months
Time Frame: 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
|
Change in Baseline Summary of Diabetes Self-Care Activities at 6 months
Time Frame: 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
|
Change in Baseline Food Frequency Questionnaire at 3 months
Time Frame: 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
|
Change in Baseline Food Frequency Questionnaire at 6 months
Time Frame: 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
|
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
Time Frame: 3 months
|
Samples will be processed by Quest Diagnostics Inc and assayed by Immunoturbidimetry (Integra 800, Roche).
|
3 months
|
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months
Time Frame: 6 months
|
Samples will be processed by Quest Diagnostics Inc and assayed by Immunoturbidimetry (Integra 800, Roche).
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ahmed Khattab, MD, Scripps
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-7995
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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