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
Bibliographic record
Abstract
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
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.029 | 0.023 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.013 | 0.007 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.007 | 0.006 |
| Insufficient payload (model declined to judge) | 0.040 | 0.006 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".