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IRCT20260610069736N1 IRCT 2026-06-14 Tarbiat Modares University Public title - English:Effect of a workplace diabetes self-management program on employees with type 2 diabetes W-EBDIM Design and measuring the effect of an evidence-based Interventional Mapping on the level of self-management, self-efficacy, quality of life, distress, and experiences of living with type 2 diabetes of Iraqi employees: Mixed Method (hybrid design). 2026-09-01 anticipated 60 Pending https://irct.ir/trial/90757 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: This trial is the intervention evaluation stage of a multiphase mixed-methods study. The current registration covers only the randomized trial stage. Before the trial, quantitative and qualitative findings will be integrated to design a workplace evidence-based diabetes intervention mapping program. The final program will then be evaluated in a two-arm parallel randomized controlled trial comparing the program plus usual care with usual care only, Randomization description: After eligibility confirmation, written informed consent, and baseline assessment, eligible participants will be assigned to the intervention or control group using computer-generated permuted block randomization with a 1:1 allocation ratio. The unit of randomization will be the individual participant. The random allocation sequence will be prepared by an independent statistician who is not involved in recruitment, intervention delivery, or outcome assessment. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes or an equivalent secure computerized allocation system. Group assignment will be revealed only after eligibility confirmation, consent, and baseline assessment have been completed. N/A Type 2 diabetes mellitus. Intervention 1: Intervention group: Participants will receive the Workplace Evidence-Based Diabetes Intervention Mapping (W-EBDIM) program in addition to usual care. W-EBDIM is a structured workplace-based educational and behavioral diabetes self-management program developed using Intervention Mapping and integrated quantitative and qualitative findings. It includes group sessions, culturally adapted Arabic materials, goal-setting, self-monitoring, problem-solving activities, peer discussion, and guidance on workplace nutrition, physical activity, medication adherence, blood glucose monitoring, and prevention of hypo- and hyperglycemia. Intervention 2: Control group: Participants will not receive the W-EBDIM educational program during the study period and will continue to receive only their standard routine care. No - There is not a plan to make this available Justification or reason for not sharing IPD is Deidentified individual participant data will not be shared because the study involves health-related data from employees recruited from specific workplace and hospital settings. Even after deidentification, there may be a risk of indirect identification. Data sharing is also limited by the informed consent conditions and ethical approvals. Only aggregated results will be reported in publications and academic outputs.
public Anas Karaghool
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 14115-111 +98 904 035 3392 Anas.karaghool@modares.ac.ir Tarbiat Modares University scientific Fatemeh Alhani
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 14115-111 +98 912 349 5476 alhani_f@modares.ac.ir Tarbiat Modares University Iraq Iraq Iraq Iraq Iraqi governmental employee working in one of the approved study sites in Baghdad Confirmed diagnosis of type 2 diabetes mellitus by a physician or HbA1c/blood test for at least six months Aged between 30 and 60 years Receiving diabetes management through antidiabetic medication and/or lifestyle modification Able to read Arabic or complete the Arabic questionnaires with researcher assistance Willing to participate voluntarily and provide written informed consent 30 years 60 years Both Diagnosis of type 1 diabetes, gestational diabetes, or any other type of diabetes other than type 2 diabetes mellitus Healthcare professionals, including physicians and nurses, or highly specialized clinical staff whose advanced medical knowledge may bias baseline scores Severe physical or mental illness that prevents participation in the intervention or follow-up assessment Inability to complete the questionnaires adequately, even with researcher assistance Transfer, resignation, migration, or planned absence from the study site before follow-up assessment Withdrawal of consent or discontinuation of participation during the study E11 Type 2 diabetes mellitus Behavior N/A Intervention group: Participants will receive the Workplace Evidence-Based Diabetes Intervention Mapping (W-EBDIM) program in addition to usual care. W-EBDIM is a structured workplace-based educational and behavioral diabetes self-management program developed using Intervention Mapping and integrated quantitative and qualitative findings. It includes group sessions, culturally adapted Arabic materials, goal-setting, self-monitoring, problem-solving activities, peer discussion, and guidance on workplace nutrition, physical activity, medication adherence, blood glucose monitoring, and prevention of hypo- and hyperglycemia. Control group: Participants will not receive the W-EBDIM educational program during the study period and will continue to receive only their standard routine care. Diabetes self-management. Timepoint: Baseline (T0) and post-intervention (T1). Method of measurement: Diabetes Self-Management Questionnaire-Revised (DSMQ-R), Arabic version. The total score will be calculated according to the questionnaire scoring instructions; higher scores indicate better diabetes self-management. Diabetes self-efficacy. Timepoint: Baseline (T0) and post-intervention (T1). Method of measurement: Diabetes Self-Efficacy Scale (DSES), Arabic version. The total score will be calculated according to the scale scoring instructions; higher scores indicate greater diabetes self-efficacy. Diabetes-specific quality of life. Timepoint: Baseline (T0) and post-intervention (T1). Method of measurement: Quality of Life Scale for Iraqi Diabetes Mellitus Patients (QOLSID), Arabic version. The total score will be calculated according to the scale scoring instructions; higher scores indicate better diabetes-specific quality of life. Diabetes distress. Timepoint: Baseline (T0) and post-intervention (T1). Method of measurement: The 5-item Problem Areas in Diabetes Scale (PAID-5), Arabic version. The total score ranges from 0 to 20; higher scores indicate greater diabetes-related emotional distress. Tarbiat Modares University Approved 2026-02-07 Ethics Committee of Tarbiat Modares University Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of) Approved 2026-04-22 Research Ethics Committee of the Iraqi Ministry of Health Iraqi Ministry of Health, National Centre for Training and Human Development, Baghdad, Iraq Baghdad Baghdad Iraq