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Diabetes Type 2NCT05378620

Project Dulce for Filipino-Americans With Type 2 Diabetes

A study testing Project Dulce + Dulce Digital in people with Diabetes Type 2, run by Scripps Whittier Diabetes Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Type 2
What is being tested?
Project Dulce + Dulce Digital
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesUnited States
Study dates
17 Oct 2022to 12 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Severe illness precluding frequent visits to clinic
  • Liver function tests (ALT and AST) > 3 times the upper limit of normal
  • Body mass index ≤ 23 kg/cm
  • History of malignancy, except subjects who have been disease-free for >years, or whose only malignancy has been basal or squamous cell skin carcinoma
  • Creatinine >3.5
  • History of drug or alcohol abuse within 12 months prior to enrollment
Show all 13Show fewer
  • Not a permanent resident in the area
  • Current enrollee in Project Dulce
  • Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening
  • Anemia
  • Type 1 or gestational diabetes
  • Pregnant
  • Are currently participating in another diabetes-related study

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • San Ysidro Health

    National City, California, 91950

  • Scripps Whittier Diabetes Institute

    San Diego, California, 92037

Other trials in United States

About this study

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.

Read the detailed description

Type 2 diabetes mellitus (T2DM) disproportionately affects racial and ethnic minority populations. Among Asian Americans, Filipino Americans (FA) have the second highest T2DM prevalence and have an increased risk for developing complications due to lack of engagement in health protective behaviors (e.g., eating healthfully, obtaining adequate activity) and increased social and environmental barriers to optimal self-management (e.g., access to culturally appropriate education programs). While diabetes self-management education (DSME) programs have been shown to significantly improve T2DM outcomes, fewer than 10% of newly-diagnosed individuals receive DSMES within the first year of diagnosis.

Project Dulce is an American Diabetes Association (ADA)-recognized adult T2DM management program developed to address the needs of a racially and ethnically diverse San Diego population. Project Dulce includes a multi-disciplinary team with peer educators delivering DSMES. Previous trials have shown Project Dulce team-care improves clinical management and reduces costs (e.g., Philis-Tsimikas et al., 2004; Gilmer et al., 2005), and that the peer education alone improves clinical outcomes in Hispanics with T2DM (Philis-Tsimikas et al., 2011). The program has been disseminated locally, nationally, and internationally to White and Hispanic populations and has now served over 20,000 people. More recently, the peer education content was adapted via the Dulce Digital program to extend the reach of the care team through text messages derived from the Project Dulce curriculum, including medication reminders, and blood glucose monitoring prompts. This program led to a significant reduction of hemoglobin AHbA1c across 10 months versus usual care in Hispanics with diabetes (Fortmann et al., 2017). While Project Dulce has been adapted and demonstrated improvements in clinical and cost outcomes in Hispanic patients, cultural and digital adaptations are needed to increase and facilitate use in other racial and ethnic minority groups including FAs.

Using a Community-Based Participatory Research (CBPR) approach, this study will adapt Project Dulce + Dulce Digital for implementation in FA adults with T2DM. Cultural adaptations aims to facilitate and enhance patient-centered approaches by addressing barriers to DSMES unique to this population, such as linguistic challenges, health literacy and numeracy, cultural beliefs and values, and technology access and use. In addition, ADA has recommended the use of digital technologies as effective methods to deliver DSMES and mitigate barriers to participation. The adaptation process will be demonstrated in partnership with a local Federally Qualified Health Center (FQHC) serving a large number of FAs from diverse socioeconomic backgrounds. This study aims to culturally adapt Project Dulce and Dulce Digital for FAs with T2DM. Specifically, this study aims to:

  1. examine the effectiveness of the culturally adapted Project Dulce + Dulce Digital in improving diabetes knowledge, attitudes, and beliefs among FAs with T2DM;
  2. examine the effectiveness of the culturally adapted Project Dulce + Dulce Digital in improving HbA1C and self-management behaviors (i.e., diet, physical activity, medication adherence, foot care, blood glucose monitoring from baseline to 3- and 6-months; and
  3. evaluate the acceptability and feasibility of the culturally adapted Project Dulce + Dulce Digital when delivered by FA peer educator to FA patients with T2DM.
Conditions
Diabetes Type 2
Being tested
Project Dulce + Dulce Digital
Keywords
Diabetes, Self-Management, Education
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Project Dulce + Dulce DigitalBehavioural

    Project Dulce will consist of a group diabetes self-management program consisting of a 5-week curriculum delivered by a peer educator in Tagalog. The curriculum provides new knowledge as well as skills and tools needed to adapt to a life with diabetes and change behaviors. The curriculum covers diabetes and its complication, the role of diet, exercise, and medication, and the importance of self-monitoring. It is presented over 5 weeks where participants will learn and practice self-management skills, and help one another address family, cultural, or health system barriers to managing your diabetes. Following the 5-week curriculum, participants will be enrolled in the digital texting platform, Dulce Digital, in which they will receive on-going support via text messages derived from the curriculum, medication reminders, and blood glucose monitoring prompts in Tagalog.

Study groups in NCT05378620
Study groupRoleWhat they receive
Project Dulce + Dulce DigitalOtherPatients 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.
Receives: Behavioral: Project Dulce + Dulce Digital

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Diabetes Knowledge at 3 months

    Diabetes Knowledge Test (Fitzgerald, Funnell, Anderson, et al., 2016) is a 23-item measure of diabetes knowledge, with general questions related to symptoms, self-management (e.g., diet, exercise, foot care, blood glucose monitoring, insulin) , and complications (e.g., low and high blood sugar). Greater scores indicate greater diabetes knowledge.

    Measured: 3 months

  2. Change from Baseline Diabetes Knowledge at 6 months

    Diabetes Knowledge Test (Fitzgerald, Funnell, Anderson, et al., 2016) is a 23-item measure of diabetes knowledge, with general questions related to symptoms, self-management (e.g., diet, exercise, foot care, blood glucose monitoring, insulin) , and complications (e.g., low and high blood sugar). Greater scores indicate greater diabetes knowledge.

    Measured: 6 months

  3. Change in Baseline Self-Efficacy for Diabetes Scale at 3 months

    Stanford Self-Efficacy for Diabetes Scale (Lorig, Stewart, Ritter, et al., 1996) is comprised of 8 items that measure the confidence of a participant in performing self-care activities such as eating meals every 4 to 5 hours, following a healthful diet, exercising, and blood glucose monitoring. Response options range from 1=not at all confident to 10=totally confident, with higher scores indicating greater self-efficacy.

    Measured: 3 months

  4. Change in Baseline Self-Efficacy for Diabetes Scale at 6 months

    Stanford Self-Efficacy for Diabetes Scale (Lorig, Stewart, Ritter, et al., 1996) is comprised of 8 items that measure the confidence of a participant in performing self-care activities such as eating meals every 4 to 5 hours, following a healthful diet, exercising, and blood glucose monitoring. Response options range from 1=not at all confident to 10=totally confident, with higher scores indicating greater self-efficacy.

    Measured: 6 months

Secondary outcomes (8)
  1. Change in Baseline Summary of Diabetes Self-Care Activities at 3 months

    Summary of Diabetes Self-Care Activities measure (Toobert, Hampson, \& Glassgow, 2000) is a 13-item brief questionnaire that assesses respondents adherence to self-management behavior recommendations in the past 7 days, including general and specific diet, exercise, blood glucose testing, foot care, medication adherence, and smoking, with greater scores indicating greater adherence.

    Measured: 3 months

  2. Change in Baseline Summary of Diabetes Self-Care Activities at 6 months

    Summary of Diabetes Self-Care Activities measure (Toobert, Hampson, \& Glassgow, 2000) is a 13-item brief questionnaire that assesses respondents adherence to self-management behavior recommendations in the past 7 days, including general and specific diet, exercise, blood glucose testing, foot care, medication adherence, and smoking, with greater scores indicating greater adherence.

    Measured: 6 months

  3. Change in Baseline Block Food Frequency Questionnaire at 3 months

    Block Food Frequency Questionnaire (Block et al., 1995) measures frequency of fruit, vegetable and fiber consumption, and fat (and saturated fat) consumption each week using seven frequency categories ranging from less than once a week to 2 or more a day. Minor modifications were included to add food items commonly consumed in a Filipino diet (e.g., "Any other vegetables such as corn broccoli, zucchini, or vegetables commonly used Filipino cooking such as sitaw, kalabasa, sayote, upo, monggo, malunggay, amapalaya, pechay, kangkong, okra, etc.)

    Measured: 3 months

  4. Change in Baseline Block Food Frequency Questionnaire at 6 months

    Block Food Frequency Questionnaire (Block et al., 1995) measures frequency of fruit, vegetable and fiber consumption, and fat (and saturated fat) consumption each week using seven frequency categories ranging from less than once a week to 2 or more a day. Minor modifications were included to add food items commonly consumed in a Filipino diet (e.g., "Any other vegetables such as corn broccoli, zucchini, or vegetables commonly used Filipino cooking such as sitaw, kalabasa, sayote, upo, monggo, malunggay, amapalaya, pechay, kangkong, okra, etc.)

    Measured: 6 months

  5. Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months

    International Physical Activity -Short Form (Craig et al., 2003) assesses the amount of physical activity (work, leisure, and other) and sedentary time in the past 7 days.

    Measured: 3 months

  6. Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months

    International Physical Activity -Short Form (Craig et al., 2003) assesses the amount of physical activity (work, leisure, and other) and sedentary time in the past 7 days.

    Measured: 6 months

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

    HbA1c is measure of blood sugar level and assessed using blood samples following a 12-hour fast. Samples will be processed by Quest Diagnostics Inc and assayed by Immunoturbidimetry (Integra 800, Roche).

    Measured: 3 months

  8. Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months; % Units

    HbA1c is measure of blood sugar level and assessed using blood samples following a 12-hour fast. Samples will be processed by Quest Diagnostics Inc and assayed by Immunoturbidimetry (Integra 800, Roche).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start17 Oct 2022
  3. Primary completion12 Dec 2025
  4. Study completion12 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05378620
Sponsor's protocol ID
IRB-22-7886
Other IDs
KL2TR002552
Status last verified
Mar 2026
First submitted
10 May 2022
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Project Dulce + Dulce Digital in people with Diabetes Type 2, run by Scripps Whittier Diabetes Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Diabetes Knowledge at 3 months (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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