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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)

Must not have

Severe illness precluding frequent visits to clinic

Type 1 or gestational diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I can speak, read, write, and understand both English and Arabic.

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I have been diagnosed with type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am too ill to visit the clinic often.

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I have type 1 diabetes or had diabetes during pregnancy.

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I have anemia.

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My primary language is not English or Arabic.

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I am not willing to carry a mobile phone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hypoglycemic Agents

Change from Baseline Health Belief Model Scale at 3 months

+5 more

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 7Eligibility criteria met