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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with type 2 diabetes.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Participant Satisfaction
Recruitment and Retention

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.

Find a Location

Who is running the clinical trial?

Scripps Whittier Diabetes InstituteLead Sponsor
17 Previous Clinical Trials
5,341 Total Patients Enrolled
3 Trials studying Diabetes
1,422 Patients Enrolled for Diabetes
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,701 Total Patients Enrolled
Emily Rose N. San Diego, PhDPrincipal InvestigatorScripps Whittier Diabetes Institute

Media Library

Project Dulce + Dulce Digital Clinical Trial Eligibility Overview. Trial Name: NCT05378620 — N/A
Diabetes Research Study Groups: Project Dulce + Dulce Digital
Diabetes Clinical Trial 2023: Project Dulce + Dulce Digital Highlights & Side Effects. Trial Name: NCT05378620 — N/A
Project Dulce + Dulce Digital 2023 Treatment Timeline for Medical Study. Trial Name: NCT05378620 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period for this trial still open?

"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is actively enrolling participants; it was first posted on October 17th 2022 and recently updated on the 19th of the same month. The study needs to find a total of 48 patients from one respective medical centre."

Answered by AI

How many participants have been enrolled in this investigation?

"Affirmative. The clinicaltrials.gov database indicates that this examination, which was first posted on October 17th 2022, is currently looking for candidates. Approximately 48 individuals need to be recruited from 1 site."

Answered by AI

What are the principal goals of this trial?

"The primary evaluation of this study, which is to be conducted over a three month period, will monitor changes in the patient's understanding of diabetes. Secondary assessments include tracking any alterations in glycosylated hemoglobin A1C levels measured through immunoturbidimetry by Quest Diagnostics Inc., monitoring adherence to self-care activities as outlined by Toobert et al. (2000) with higher scores indicating greater compliance and ascertaining shifts from baseline consumption rates for fruits/vegetables/fiber versus fat intake determined by Block et al.'s 1995 questionnaire, modified to incorporate Filipino dietary staples."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Scripps Whittier Diabetes Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Project Dulce for Filipino-Americans With Type 2 Diabetes
Athena Philis-Tsimikas 2022. "Project Dulce for Filipino-Americans With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05378620.
~21 spots leftby Jun 2025
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