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IRCT20260621069908N1 IRCT 2026-07-18 Shahid Beheshti University of Medical Sciences Investigating the Effect of Healthy Lifestyle Education Based on Iranian Traditional Medicine in Schools on the Quality of Life of Primary School Students and Parental Empowerment Investigating the Effect of a Multicomponent Healthy Lifestyle Education Program Based on Persian Medicine in Schools on the Quality of Life of Elementary School Students and Parental Self-Efficacy: A Pilot Study 2026-09-23 anticipated 60 Pending https://irct.ir/trial/91080 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: First, one district will be selected by simple random sampling from the educational districts. Then, two public primary schools from that district will be randomly selected. Finally, one of these schools will be randomly assigned to the intervention group and the other to the control group. The unit of randomization in this study is the ‘school’ (cluster). N/A Promotion of a healthy lifestyle and health-promoting behaviors, quality of life of primary school students, and parental self-efficacy. Intervention 1: Intervention group: Parents of primary school students who participate in the multi-component healthy lifestyle education program based on Iranian Traditional Medicine (including educational sessions) and receive the related training. Intervention 2: Control group: Parents of students who receive only the routine school education and do not participate in the healthy lifestyle education program based on Iranian Traditional Medicine provided in this study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available
public Zahra Valinejad
No. 8, Shams Alley, Opposite Tavanir, Valiasr St., Shahid Beheshti School of Traditional Medicine, Tehran, Iran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 zvalinejad1.20@gmail.com Shahid Beheshti University of Medical Sciences scientific Reihane Alipour
No. 8, Shams Alley, Opposite Tavanir, Valiasr St., Shahid Beheshti School of Traditional Medicine, Tehran, Iran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 alipouram71@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Students in grades one to three of primary school (first stage of primary education) Written informed consent obtained from a parent (father or mother) Minimum literacy level (ability to read and write) for the participating parent Access to the internet and a smartphone for the participating parent no limit no limit Both Students with chronic underlying medical conditions (e.g., seizures, diabetes, epilepsy, cancer, hypothyroidism, morbid obesity or underweight, autism, ADHD, etc.) Students living in single-parent households (due to bereavement or divorce) Parents who are currently undergoing treatment for psychiatric or mental health disorders (e.g., severe anger, aggression, depression, etc.) Lifestyle Lifestyle Intervention group: Parents of primary school students who participate in the multi-component healthy lifestyle education program based on Iranian Traditional Medicine (including educational sessions) and receive the related training Control group: Parents of students who receive only the routine school education and do not participate in the healthy lifestyle education program based on Iranian Traditional Medicine provided in this study Mean score of children’s health-promoting behaviors based on a researcher-made checklist (Persian Medicine-based). Timepoint: before, immediately after, and 3 months after the intervention. Method of measurement: A Persian Medicine-based questionnaire/checklist for assessing children’s health-promoting behaviors, completed by the parents. Quality of life of primary school students: The mean score obtained based on the questionnaire. Timepoint: Before the intervention, immediately after the intervention, and 3 months after the intervention. Method of measurement: Pediatric Quality of Life Inventory (PedsQL), completed by parents. Parental self-efficacy: Mean score obtained from the Parenting Self-Agency Measure (PSAM). Timepoint: Before the intervention, immediately after the intervention, and 3 months after the intervention. Method of measurement: Parenting Self-Agency Measure (PSAM), completed by parents. Shahid Beheshti University of Medical Sciences Approved 2026-01-25 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Daneshjoo Boulevard, Valanjak Tehran Tehran Iran (Islamic Republic of)