Project Dulce for Filipino-Americans With Type 2 Diabetes

NCT05378620 | Completed

• 2 other identifiers: IRB-22-7886KL2TR002552
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Diabetes Type 2

Keywords

Diabetes; Self-Management; Education

Outcome Measures

Primary Outcomes (4)

• 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.

  3 months

• 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.

  6 months

• 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.

  3 months

• 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.

  6 months

Secondary Outcomes (8)

• Change in Baseline Summary of Diabetes Self-Care Activities at 3 months

  3 months

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

  6 months

• Change in Baseline Block Food Frequency Questionnaire at 3 months

  3 months

• Change in Baseline Block Food Frequency Questionnaire at 6 months

  6 months

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

  3 months

Other Outcomes (2)

• Recruitment and Retention

  6 months

• Participant Satisfaction

  6 months

Study Arms (1)

Project Dulce + Dulce Digital

OTHER

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.

Behavioral: Project Dulce + Dulce Digital

Interventions

Project Dulce + Dulce Digital BEHAVIORAL

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.

Project Dulce + Dulce Digital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Scripps Whittier Diabetes Institute: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (2)

San Ysidro Health

National City, California, 91950, United States

Location

Scripps Whittier Diabetes Institute

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Emily Rose N. San Diego, PhD

  Scripps Whittier Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Corporate Vice President

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 18, 2022
• Study Start: October 17, 2022
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)