NCT05378620Completed
Project Dulce for Filipino-Americans With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
This study aims to culturally adapt an existing American Diabetes Association (ADA)-recognized diabetes self-management and support or DSMES (Diabetes Self Management Education Support) program (Project Dulce) and integrate an evidence-based text messaging program (Dulce Digital) for implementation in Filipino Americans (FAs) with type 2 diabetes mellitus (T2DM). Cultural adaptations aims to facilitate and enhance patient centered approaches and increase participant engagement by addressing barriers to DSMES unique to FAs, such as linguistic challenges, health literacy and numeracy, cultural beliefs and values, and technology access and use. In addition, this study aims to examine the effectiveness of the culturally and digitally adapted Project Dulce + Dulce Digital in improving diabetes knowledge, belief, attitudes, hemoglobin A1C (glycosylated hemoglobin), and self-management behaviors at baseline to 3 months and 6 months. The unprecedented increase of T2DM prevalence among racial and ethnic minority populations including FAs in recent decades demands for effective strategies to meet the needs in DSMES in this population. The outcomes of the current study will demonstrate that the culturally adapted Project Dulce and integration of Dulce Digital is effective in addressing the needs FAs, an underserved racial and ethnic minority group in high need of culturally appropriate DSMES.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 10 May 2022
- Start date
- 17 Oct 2022
- Primary completion date
- 12 Dec 2025
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Diseases
- Type 2 diabetes
- NCT number
- NCT05378620
What you commit to
- Study type: Interventional
- Participants enrolled: 29
- From 17 Oct 2022 to the primary completion date, 12 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of drug or alcohol abuse within 12 months prior to enrollment
- Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening
Other illness
- Severe illness precluding frequent visits to clinic
- History of malignancy, except subjects who have been disease-free for \>years, or whose only malignancy has been basal or squamous cell skin carcinoma
- Type 1 or gestational diabetes
- Are currently participating in another diabetes-related study
Lab values
- Liver function tests (ALT and AST) \> 3 times the upper limit of normal
- Creatinine \>3.5
Other
- Body mass index ≤ 23 kg/cm
- Not a permanent resident in the area
- Current enrollee in Project Dulce
- Anemia
- Pregnant
Who the study is looking for
- Self-identified Filipino
- Diagnosed with T2DM
- Registered at Scripps Health or San Ysidro Health (or willing to register)
- HbA1c ≥7.5% and/or systolic blood pressure ≥ 140, and/or LDL-C ≥ 100 mg/dL within 90 days
- Able to speak, read, write, and comprehend in English and Tagalog
- Have access to a cell phone that can receive/send text messages throughout the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Ysidro Health Coordinator of this site? Confirm its status | National City | United States | Unknown status |
| Scripps Whittier Diabetes Institute Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.