JMIR Publications

ABSTRACT

Background:

Individuals with non-Western backgrounds consistently exhibit a higher risk of type 2 diabetes (T2D) compared with ethnic Danes. Factors such as health behavior, limited healthcare access, and social determinants of health often contribute to this disparity. Culturally sensitive interventions are crucial, yet effective interventions for managing T2D in non-Western populations re-main limited.

Objective:

This study examines the effect of a one-year person-centered and culturally sensitive intervention on improving glycemic control (HbA1c) among individuals with T2D and non-Western backgrounds. The secondary objectives are to improve diabetes management and overall well-being.

Methods:

The present study is designed as a two-arm randomized controlled trial. 96 women and men with T2D (HbA1c≥53 mmol/mol) speaking either Arabic, Turkish, or Urdu as their native language will be randomized for one year to an 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 one 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 using interviews. The study is approved by the Ethics Committee of the Capital Region of Denmark (H-23042245).

Results:

A 5.0 mmol/mol (0.5%-DCCT) 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 October 2024, 70 participants have been recruited, with recruitment ongoing until 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 individuals with a non-Western background. The study employs a robust methodological design and will present an alternative avenue for man-aging T2D and improving overall well-being. The study offers valuable insights into the experiences of participants and healthcare professionals, including potential obstacles and strategies for implementation in outpatient clinics. Clinical Trial: Clinicaltrials.gov NCT06147245.