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Project Dulce for Type 2 Diabetes
N/A
Recruiting
Led By Ahmed Khattab, MD
Research Sponsored by Scripps Whittier Diabetes Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to speak, read, write, and comprehend in English and Arabic
Diagnosed with type 2 diabetes mellitus (T2DM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial aims to improve diabetes care for Arab Americans by providing culturally relevant educational resources & support.
Who is the study for?
This trial is for Arab-Americans who can communicate in English and Arabic, have type 2 diabetes with a recent HbA1c of at least 8%, and are registered or willing to register at the community clinic. They must not have severe illnesses, certain past malignancies, liver issues, anemia, other types of diabetes, or be pregnant.Check my eligibility
What is being tested?
Project Dulce Arabic is being tested; it's a culturally tailored education program for managing type 2 diabetes that includes peer-led sessions in Arabic and a text messaging service over three months. The goal is to improve patients' knowledge about diabetes and their self-care habits.See study design
What are the potential side effects?
Since this intervention involves educational resources rather than medication, typical drug side effects aren't expected. However, participants may experience stress or anxiety from lifestyle changes or information overload.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can speak, read, write, and understand both English and Arabic.
Select...
I have been diagnosed with type 2 diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hypoglycemic Agents
Hypoglycemic Agents
Change from Baseline Health Belief Model Scale at 3 months
+5 moreSecondary outcome measures
Change in Baseline Food Frequency Questionnaire at 3 months
Change in Baseline Food Frequency Questionnaire at 6 months
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Project Dulce + Dulce DigitalExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Scripps Whittier Diabetes InstituteLead Sponsor
17 Previous Clinical Trials
5,339 Total Patients Enrolled
Ahmed Khattab, MDPrincipal InvestigatorScripps
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You weigh less than a certain amount for your height.I can speak, read, write, and understand both English and Arabic.Your blood sugar level has been consistently high in the past month.You identify as Arab.I have type 1 diabetes or had diabetes during pregnancy.I am too ill to visit the clinic often.Your creatinine level is higher than 3.5.Your liver function tests show that your ALT and AST levels are more than three times the normal limit.I have anemia.My primary language is not English or Arabic.I am not willing to carry a mobile phone.I haven't donated blood or plasma recently.You are currently participating in Project Dulce.I have been cancer-free for over 5 years, or I've only had skin cancer.I have been diagnosed with type 2 diabetes.You have had issues with using drugs or alcohol in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Project Dulce + Dulce Digital
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What outcomes is this investigation aiming to accomplish?
"The principal outcome of this study, monitored over 6 months, is the alteration in Baseline Diabetes Knowledge. Secondary results are assessed at 3 month intervals and include changes to International Physical Activity Questionnaire-Short Form (Craig et al., 2003), Food Frequency Questionnaire (Alqahtani et al., 2017) consumption patterns for fruits, vegetables, and other common foods among Arab Americans."
Answered by AI
Are there opportunities for participants currently available with this research endeavor?
"Based on the information housed on clinicaltrials.gov, this medical study is not currently enlisting patients. The trial was initially posted in November of 2022 and last edited October 12th 2022. Although this particular research project does not require participants at present, 1392 other trials are actively seeking volunteers for their studies."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
San Ysidro Health
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