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Project Dulce + Dulce Digital for Type 2 Diabetes

N/A

Recruiting

Led By Emily Rose N. San Diego, PhD

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

Diagnosed with T2DM

Be older than 18 years old

Must not have

Not willing to carry a mobile phone

Severe illness precluding frequent visits to clinic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a culturally adapted diabetes self-management program, delivered either in person or via text message, can improve diabetes knowledge and control in Filipino Americans with type 2 diabetes.

Who is the study for?

This trial is for Filipino-Americans with type 2 diabetes who can speak English and Tagalog, have an HbA1c level of ≥8%, and are registered or willing to register at a community clinic. It's not for those with severe illnesses, certain liver conditions, low body mass index, pregnancy, recent history of cancer (except some skin cancers), high creatinine levels, recent substance abuse issues, non-permanent residents in the area or current enrollees in Project Dulce.

What is being tested?

The study tests a culturally adapted diabetes self-management program called Project Dulce combined with a text messaging service named Dulce Digital. The goal is to improve diabetes knowledge and self-care among Filipino Americans by addressing cultural barriers. Effectiveness will be measured through changes in beliefs, attitudes towards diabetes management and hemoglobin A1C levels over 3 to 6 months.

What are the potential side effects?

Since this intervention involves education and digital communication rather than medication or invasive procedures, traditional side effects are not expected. However participants may experience discomfort from frequent monitoring of their health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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 not willing to carry a mobile phone.

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I have a severe illness that prevents me from visiting the clinic often.

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I have type 1 diabetes or had diabetes during pregnancy.

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English or Tagalog is not my primary language.

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

Change from Baseline Diabetes Knowledge at 3 months

Change from Baseline Diabetes Knowledge at 6 months

Change from Baseline Health Belief Model Scale at 3 months

+3 more

Secondary study objectives

Change in Baseline Block Food Frequency Questionnaire at 3 months

Change in Baseline Block Food Frequency Questionnaire at 6 months

Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months; % Units

+5 more

Other study objectives

Participant Satisfaction

Recruitment and Retention

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

Patients 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 / 5Eligibility criteria met