The effectiveness of gamification interventions on improving sedentary behaviors, self-care, and cognitive decline in the elderly: A Randomized Control trial study

determine the effectiveness of a gamification intervention compared with usual care on reducing sedentary behaviors, improving self-care, and reducing cognitive decline in older adults aged 60 years and older.

Parallel randomized controlled trial, single-blind, with two experimental and control groups, on 190 older adults aged 60 years and older (95 in each group). Randomization is performed using block randomization with blocks of 4 and 6 and an allocation ratio of 1:1. Trial phase is not applicable (non-pharmacological intervention).

A parallel, single-blind RCT in Yasuj, Iran, randomized 190 older adults (60+ years) from health centers, after informed consent, using block randomization into two groups of 95. The experimental group received an 8-week gamification intervention (3 sessions/week, 60–90 minutes each, groups of 10–15) including physical activity, cognitive training, and self-care discussion. The control group received usual care (health education and a pamphlet). Pre- and post-test assessments were performed by a blinded assessor.

Older adults aged 60 years and older residing in Yasuj city, able to communicate verbally and perform activities of daily living, without severe cognitive impairment (MoCA score of 18 or higher), willing to participate and signing the informed consent form, will be included in the study. No specific exclusion criteria before randomization have been defined.

Experimental group: Gamification intervention, 8 weeks, 3 sessions per week, each session 60 to 90 minutes, including physical activity, cognitive training, and self-care discussion. Control group: Usual care including general health education and a healthy lifestyle pamphlet, without gamification.

Sedentary behaviors; self-care; cognitive decline (cognitive function).

Randomization method: Block randomization was performed with variable block sizes of 4 and 6 and an allocation ratio of 1:1. No quasi-randomization methods were used. Unit of randomization: Individual. Stratification: Stratified randomization was not used for allocation. Randomization tool: Computer-generated random number software. Random sequence generation: The random sequence was generated by an independent statistician, separate from the research process, using computer-generated random number software, in random blocks of variable sizes of 4 and 6 with an allocation ratio of 1:1. The sequence was kept confidential until allocation. Allocation concealment: Allocation concealment was performed using opaque, numbered, and sealed envelopes. The contents of the envelopes were prepared by an individual independent of the research process, and the envelopes were numbered sequentially. The envelopes were impermeable to light, and the next numbered envelope was opened only after recording the participant’s name and details and obtaining informed consent.

This study is single-blind. Only the outcome assessors and the data analyst are unaware of group allocation (data are analyzed using codes A/B). Participants, researchers, and intervention providers are not blinded due to the non-pharmacological and interactive nature of the study. There is no data monitoring committee.

Title and Further Details about the Data/Document - English: Document Title: De-identified individual participant data and supporting trial documents. Details: After the study completion and publication of the main results, de-identified individual participant data (without name, national ID, address, and contact information) can be shared. These data include demographic information, scores of the Physical Activity Scale for the Elderly, the Self-Care Ability Scale for the Elderly, the Montreal Cognitive Assessment, and pedometer data. Access is provided only after a written request from eligible researchers, approval by the ethics committee, and signing a confidentiality agreement. Raw data that can identify individuals and identity information will not be shared under any circumstances.

Data access will begin 6 months after the publication of the main study results and will remain available for 5 years.

Access to de-identified data is possible only for researchers working in academic and scientific institutions, after submitting a written request, approval by the ethics committee, and signing a confidentiality agreement. Individuals working in industry or other non-scientific organizations are not permitted to receive the data.

The de-identified data and study documents may be used only for non-commercial research purposes, including secondary analyses, meta-analyses, verification of findings, and advancing scientific knowledge in the field of older adult health. Commercial, industrial, or for-profit use of the data is prohibited. Conditions of use include: Submitting a written request stating the specific research purpose. Obtaining approval from the requesting institution's ethics committee. Signing a data use agreement that includes a commitment not to attempt re-identification of individuals, not to transfer the data to third parties, and to cite the original study in publications. Publishing results from secondary analyses only with citation of the original study as the data source. Not using the data for clinical, diagnostic, or commercial purposes. Full compliance with confidentiality and research ethics principles.

Applicants may request access to the de-identified data or study documents in the following order: Submit a written request via email to the principal investigator: Dr. Ayoub Hashemi Email: a.hashemi@yu.ac.ir Send an official letter by post to: Yasuj University, Daneshjoo Street, Yasuj, Iran Postal Code: 7591874934 Attention: Dr. Ayoub Hashemi Call Yasuj University for further guidance: Phone: 0098 74 33221000 Visit the university website for additional contact information: www.yu.ac.ir Applicants must state in their request the research purpose, their affiliated institution, and their commitment to confidentiality principles and the conditions of use.

The process for requesting access to de-identified data or study documents is as follows: Submit a written request: The applicant sends a request via email to the principal investigator (Dr. Ayoub Hashemi, a.hashemi@yu.ac.ir). The request must include the applicant's name and affiliated institution, specific research purpose, type of data or documents needed, approval from the applicant's institutional ethics committee, and a commitment to confidentiality and conditions of use. Acknowledgement of receipt: The research team acknowledges receipt of the request within a maximum of 5 working days. Initial review: The principal investigator and research team review the request for alignment with study objectives, non-commercial use conditions, and completeness of documents. This stage takes 1 to 2 weeks. Referral to the ethics committee: If initially approved, the request is referred to the Ethics Committee of Yasuj University for final approval. This stage takes 2 to 4 weeks. Notification of outcome: The outcome (approval, rejection, or need for revision) is communicated to the applicant. Signing the data use agreement: If approved, the applicant and their institution must sign a data use agreement that includes a commitment not to attempt re-identification, not to transfer data to third parties, and to cite the original study in publications. Data preparation: The de-identified data and requested documents are prepared by the research team. This stage takes 1 to 2 weeks. Secure data delivery: Data are delivered via an encrypted link or the secure server of Yasuj University. This stage takes about 1 week. Total timeframe: If the request is complete, the entire process usually takes 6 to 10 weeks. Incomplete requests or those requiring revision take longer. Also, access to data before the end of the embargo period (6 months after publication of the main results) is not possible.

This study is a randomized, parallel, single-blind clinical trial with a non-pharmacological intervention. The intervention under investigation is gamification for older adults, and the control group receives only usual care. This project was approved by the Research Ethics Committee of Shahroud University of Technology with ethics code IR.SHAHROODUT.REC.1405.007, and its execution site is Yasuj University. Financial support for the project is provided by the Iran National Science Foundation. No placebo, pharmaceutical agent, or invasive intervention is used in this study. Trial registration will be performed before the start of sampling. Also, there is no conflict of interest for the principal investigator and project collaborators.