RECRUITING

Project Dulce for Filipino-Americans With Type 2 Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Project Dulce for Filipino-Americans With Type 2 Diabetes

Quick Facts

Study Start:2022-10-17
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05378620

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-identified Filipino
  2. * Diagnosed with T2DM
  3. * Registered in the community clinic (or willing to register)
  4. * HbA1c ≥8% within 1 month of screening
  5. * Able to speak, read, write, and comprehend in English and Tagalog
  1. * Severe illness precluding frequent visits to clinic
  2. * Liver function tests (ALT and AST) \> 3 times the upper limit of normal
  3. * Body mass index ≤ 23 kg/cm
  4. * History of malignancy, except subjects who have been disease-free for \>years, or whose only malignancy has been basal or squamous cell skin carcinoma
  5. * Creatinine \>3.5
  6. * History of drug or alcohol abuse within 12 months prior to enrollment
  7. * Not a permanent resident in the area
  8. * Current enrollee in Project Dulce
  9. * Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening
  10. * Anemia
  11. * Primary language other than English or Tagalog
  12. * Not willing to carry a mobile phone
  13. * Type 1 or gestational diabetes
  14. * Pregnant

Contacts and Locations

Study Contact

Emily Rose N. San Diego, PhD
CONTACT
858-678-7043
sandiego.emily@scrippshealth.org

Principal Investigator

Emily Rose N. San Diego, PhD
PRINCIPAL_INVESTIGATOR
Scripps Whittier Diabetes Institute

Study Locations (Sites)

Scripps Diabetes Center
Chula Vista, California, 91910
United States
San Ysidro Health
National City, California, 91950
United States
Scripps Whittier Diabetes Institute
San Diego, California, 91941
United States

Collaborators and Investigators

Sponsor: Scripps Whittier Diabetes Institute

  • Emily Rose N. San Diego, PhD, PRINCIPAL_INVESTIGATOR, Scripps Whittier Diabetes Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-17
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-10-17
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Diabetes

Additional Relevant MeSH Terms

  • Diabetes Type 2