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IRCT20260317068997N1 IRCT 2026-04-11 Psychology Department, Tehran University Studying a modern Gamified Study for diabetes self-care Improving diabetes health symptoms by using a specialized VR gamification self-care method: A parallel-group randomized controlled trial 2024-11-21 anticipated 52 Complete https://irct.ir/trial/89347 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization in this study was performed using computer‑generated stratified block randomization. After confirming eligibility and obtaining informed consent, participants were enrolled in the study. To ensure balance between study groups with respect to important baseline characteristics, randomization was stratified by age and gender. Within each stratum, participants were assigned to one of the four study groups (VR gamification intervention, MySugr application, traditional counseling, and control group) using random block allocation. The allocation sequence was generated using a computer‑based random number generator. Specifically, the website Randomization.com (https://www.randomization.com) was used to generate the block randomization sequence. The random allocation list was prepared before the start of participant recruitment by a technical assistant who was not involved in participant recruitment, intervention delivery, or outcome assessment. To ensure allocation concealment, the randomization sequence was placed in sequentially numbered, opaque, sealed envelopes. After a participant was confirmed eligible and formally enrolled, the next envelope in sequence was opened to reveal the assigned group. The principal investigator and the healthcare provider delivering the intervention were unaware of the allocation sequence prior to assignment. Due to the nature of the interventions (VR game intervention, mobile application use, or face‑to‑face counseling), blinding of participants and intervention providers was not feasible. However, to minimize potential bias, data analysis was conducted using anonymized group labels, so that the data analyst remained blinded to the actual group identities during statistical analysis, Blinding description: Due to the nature of the intervention, blinding of participants and intervention providers was not feasible. However, data analysts were blinded to group allocation; all datasets were anonymized and provided with coded labels that contained no information about the intervention type. The analyst received only de‑identified data files and had no knowledge of the participants’ assigned groups. N/A Diabetes. Intervention 1: Intervention group 1 (VR gamified group): A virtual reality–based gamification intervention designed to enhance diabetes self‑care behaviors (physical activity, dietary adherence, and blood glucose monitoring). Participants in this group used the VR game “KallehGhandi,” which was specifically developed for this study. Number of sessions: 6 sessions. Duration of each session: approximately 30–45 minutes (in the clinic using a VR headset). Overall duration: 6 weeks (one weekly session after the start of the study).Session content: In each session, participants engaged in interactive, story‑driven scenarios within the VR environment, where key diabetes self‑care concepts (e.g., healthy food choices, appropriate physical activity, and blood glucose management) were presented as game‑like challenges and missions. Immediate feedback, scoring, and level progression were used to strengthen intrinsic motivation and adherence to healthy behaviors. Initial orientation and guidance were provided by the healthcare team, and the VR sessions were delivered face‑to‑face under supervision. Intervention 2: Intervention group 2 (Monitoring App group): Use of the commercial diabetes management application MySugr as a gamified self‑care tool for logging and monitoring blood glucose and daily diabetes‑related behaviors. Number of sessions: 6 training/follow‑up sessions. Duration of each session: approximately 10-15 minutes. Overall duration: 6 weeks (one weekly session after the start of the study).Session content: During the first session, participants (and parents, when applicable) received face‑to‑face training on installing, setting up, and using the MySugr application, including logging FBS, physical activity, and food intake, viewing graphs and scores, and using reminder features. In the subsequent weekly sessions, app usage was reviewed, technical or practical issues were addressed, and participants were encouraged to maintain regular daily logging. Guidance and recommendations were provided by the healthcare team, while the core intervention focused on daily self‑directed use of the app. Intervention 3: Intervention group 3 (Traditional counseling group): standard diabetes self‑care education consistent with routine practice in specialized diabetes clinics in Iran. Number of sessions: 6 counseling sessions. Duration of each session: approximately 10-15 minutes. Overall duration: 6 weeks (one weekly session after the start of the study).Session content: Sessions were delivered by diabetes educators or trained nurses and included structured education on the nature of diabetes, the importance of regular blood glucose monitoring, dietary principles for children and adolescents with diabetes, practical recommendations for engaging in regular physical activity, and strategies for dealing with everyday challenges (e.g., parties, school, and sports activities). Each session included a brief review of the previous week’s behaviors and individualized recommendations to improve adherence. Intervention 4: Control group: Routine care without any additional structured self‑care intervention. Number of sessions: 6 follow‑up visits in line with routine clinical visits or brief assessment sessions. Duration of each session: approximately 10–20 minutes. Overall duration: 6 weeks (one weekly visit/assessment after the start of the study).Session content: Participants in this group received their usual medical care from the diabetes clinic, including physician visits, medication adjustments when needed, and general advice according to the standard protocol of the center. No extra structured program involving gamification, mobile applications, or specific educational counseling was provided, beyond the basic education normally offered as part of routine care for all patients at the clinic. Yes - There is a plan to make this available What will be shared: SPSS file named Diabetes Gamification When: Data is available upon reasonable request To whom: Practitioniers / Spacialists in health / psychology expertise Conditions: Research Criteria in Health Interventions Where to obtain: SPSS file located in google drive How to obtain: Formal request to first author/ Ruhollah Solat via email Comments:
public Javad Hatami
Dr. Kardan Street, Jalal Al‑Ahmad Street, Shahid Chamran Expressway
Tehran Iran (Islamic Republic of) 1445983861 +98 21 6111 2198 hatamijm@ut.ac.ir Psychology Department, Tehran University scientific Ruhollah Solat
Dr. Kardan Street, Jalal Al‑Ahmad Street, Shahid Chamran Expressway
Tehran Iran (Islamic Republic of) 1445983861 +98 21 8800 3740 roohi.solat@gmail.com Psychology Department, Tehran University Iran (Islamic Republic of) Formal Diagnosis of Diabetes Willingness to participate in a six week self-care program Age Range between 7-15 7 years 15 years Both Medical conditions that prevent VR headset use E10 Type 1 diabetes mellitus Behavior Behavior Behavior Behavior Intervention group 1 (VR gamified group): A virtual reality–based gamification intervention designed to enhance diabetes self‑care behaviors (physical activity, dietary adherence, and blood glucose monitoring). Participants in this group used the VR game “KallehGhandi,” which was specifically developed for this study. Number of sessions: 6 sessions. Duration of each session: approximately 30–45 minutes (in the clinic using a VR headset). Overall duration: 6 weeks (one weekly session after the start of the study).Session content: In each session, participants engaged in interactive, story‑driven scenarios within the VR environment, where key diabetes self‑care concepts (e.g., healthy food choices, appropriate physical activity, and blood glucose management) were presented as game‑like challenges and missions. Immediate feedback, scoring, and level progression were used to strengthen intrinsic motivation and adherence to healthy behaviors. Initial orientation and guidance were provided by the healthcare team, and the VR sessions were delivered face‑to‑face under supervision. Intervention group 2 (Monitoring App group): Use of the commercial diabetes management application MySugr as a gamified self‑care tool for logging and monitoring blood glucose and daily diabetes‑related behaviors. Number of sessions: 6 training/follow‑up sessions. Duration of each session: approximately 10-15 minutes. Overall duration: 6 weeks (one weekly session after the start of the study).Session content: During the first session, participants (and parents, when applicable) received face‑to‑face training on installing, setting up, and using the MySugr application, including logging FBS, physical activity, and food intake, viewing graphs and scores, and using reminder features. In the subsequent weekly sessions, app usage was reviewed, technical or practical issues were addressed, and participants were encouraged to maintain regular daily logging. Guidance and recommendations were provided by the healthcare team, while the core intervention focused on daily self‑directed use of the app. Intervention group 3 (Traditional counseling group): standard diabetes self‑care education consistent with routine practice in specialized diabetes clinics in Iran. Number of sessions: 6 counseling sessions. Duration of each session: approximately 10-15 minutes. Overall duration: 6 weeks (one weekly session after the start of the study).Session content: Sessions were delivered by diabetes educators or trained nurses and included structured education on the nature of diabetes, the importance of regular blood glucose monitoring, dietary principles for children and adolescents with diabetes, practical recommendations for engaging in regular physical activity, and strategies for dealing with everyday challenges (e.g., parties, school, and sports activities). Each session included a brief review of the previous week’s behaviors and individualized recommendations to improve adherence. Control group: Routine care without any additional structured self‑care intervention. Number of sessions: 6 follow‑up visits in line with routine clinical visits or brief assessment sessions. Duration of each session: approximately 10–20 minutes. Overall duration: 6 weeks (one weekly visit/assessment after the start of the study).Session content: Participants in this group received their usual medical care from the diabetes clinic, including physician visits, medication adjustments when needed, and general advice according to the standard protocol of the center. No extra structured program involving gamification, mobile applications, or specific educational counseling was provided, beyond the basic education normally offered as part of routine care for all patients at the clinic. Weekly average daily monitored fast blood sugar (FBS). Timepoint: Monitoring was conducted at baseline and then weekly for five weeks after the start of the study. Method of measurement: Participants measured their fasting blood sugar levels every morning using a personal glucometer and self reported the values. The recorded daily FBS values were then used by the experimenters to calculate a weekly average for each participant. Weekly sum of daily calculated physical activity (PA). Timepoint: Monitoring was conducted at baseline and then weekly for five weeks after the start of the study. Method of measurement: Physical activity was quantified using a bar metric: one bar equaled either 30 minutes of vigorous activity (e.g., gym workouts or swimming) or 60 minutes of moderate activity (e.g., jogging). The weekly sum was calculated based on this definition. Weekly average daily calculated food intake (daily calories). Timepoint: Monitoring was conducted at baseline and then weekly for five weeks after the start of the study. Method of measurement: Participants either reported their total daily caloric intake directly or reported their food descriptions, from which caloric values were estimated. A weekly average of daily caloric intake was then computed. Weekly calculated BMI. Timepoint: Monitoring was conducted at baseline and then weekly for five weeks after the start of the study. Method of measurement: Participants self-reported their weight on a weekly basis. BMI was calculated using the standard formula: weight (kg) divided by height squared (m²), which had been reported at first. HbA1c pre-test and post-test. Timepoint: Monitoring was done, once before the beginning of the trial, and once, after the end of the trial. Method of measurement: HbA1c levels were measured twice via laboratory blood tests: once before the intervention (pre-test) and once at the conclusion of the study (post-test), serving as a long-term indicator of blood glucose control. Psychology Department, Tehran University Approved 2025-11-19 Ethics committee of Psychology Department, Tehran University Faculty of Psychology and Education, University of Tehran, Dr. Kardan Street, Jalal Al‑Ahmad Street, Shahid Chamran Expressway. Tehran Tehran Iran (Islamic Republic of)