Effectiveness of a Person-Centered and Culturally Sensitive Course of Treatment in Arabic-, Turkish-, and Urdu-Speaking Individuals With Type 2 Diabetes (the ACCT2 Study): Protocol for a Pragmatic Randomized Controlled Trial

BACKGROUND: Individuals with non-Western backgrounds consistently exhibit a higher risk of type 2 diabetes (T2D) than ethnic Danes. Factors such as health behaviors, limited health care access, and social determinants of health often contribute to this disparity. Culturally sensitive interventions are crucial; however, effective interventions for managing T2D in non-Western populations remain limited.

OBJECTIVE: This study aims to examine the effect of a 1-year person-centered and culturally sensitive intervention on improving glycemic control (hemoglobin A1c [HbA1c]) in Arabic-, Turkish-, or Urdu-speaking individuals with T2D. The secondary objectives are to improve diabetes management and overall well-being.

METHODS: This study is designed as a 2-arm randomized controlled trial. A total of 96 women and men with T2D (HbA1c≥53 mmol/mol) speaking either Arabic, Turkish, or Urdu as their native language will be randomized for 1 year to a health care professional-assisted intervention group (person-centered and culturally sensitive course of treatment) or a control group (usual care) in a 1:1 ratio in Denmark. Assessments are scheduled at baseline and 1 year. The primary outcome is HbA1c, while lipids, blood pressure, and patient-reported outcomes, including well-being, diabetes management, health literacy, and use of and adherence to diabetes medication, are secondary outcomes. Feasibility and satisfaction are evaluated through interviews. The study is approved by the Ethics Committee of the Capital Region of Denmark (H-23042245).

RESULTS: A 5.0-mmol/mol change in HbA1c is the minimally important difference, requiring 88 participants. To allow for uncertainties and dropouts, the total was increased to 96. As of January 2025, a total of 88 participants have been recruited. Recruitment was completed in March 2025. Data collection will continue until December 2025, with the first results expected by March 2026.

CONCLUSIONS: This study will contribute to the limited knowledge regarding the effects of person-centered and culturally sensitive treatment approaches for T2D in Arabic-, Turkish-, or Urdu-speaking individuals. The study uses a robust methodological design and will present an alternative avenue for managing T2D and improving overall well-being. The study offers valuable insights into the experiences of participants and health care professionals, including potential obstacles and strategies for implementation in outpatient clinics.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06147245; https://clinicaltrials.gov/study/NCT06147245.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67319.