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IRCT20250327065163N1 IRCT 2025-06-08 Ahvaz University of Medical Sciences How Can Education Help Prevent Hypothyroidism in Rural Teenage Girls? Investigating the Effect of an Educational Intervention Based on the Theory of Planned Behavior on the Prevention of Hypothyroidism in Rural Adolescent Girls: A Randomized Controlled Field Trial 2023-10-23 anticipated 353 Complete https://irct.ir/trial/82632 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: his study is a randomized controlled educational intervention with a pre-and-post test approach.The schools were coded with numbers from 1 to 6. Using the RAND function in Excel, a random number is assigned to each school, and the schools were then sorted based on these numbers. The three schools with the highest random numbers were assigned to the intervention group, and the other three schools were assigned to the control group. In this study, no sampling was performed. All students who met the inclusion criteria and whose parents and themselves provided informed consent were included in the research process.st approach. N/A Hypothyroidism and its prevention in teenager students. Intervention 1: Intervention group: Received an educational program including two 30-minute in-person sessions and two weeks of daily SMS messages. The content focused on awareness, prevention, and healthy behaviors related to hypothyroidism. Sessions were conducted at school during regular hours. Intervention 2: Control group: during the course of the study, no educational interventions were conducted for the control group, and they only received routine training. Yes - There is a plan to make this available What will be shared: Title: De-identified Participant-Level Dataset and Data Dictionary Details: Includes all collected de-identified individual participant data related to primary and secondary outcomes, alongside a comprehensive data dictionary explaining variables, coding schemes, and units. When: The data will be available starting 6 months after publication of the main study results and will remain accessible for a minimum of 5 years thereafter. To whom: De-identified data and documentation will be available to qualified researchers affiliated with academic institutions, research organizations, or relevant industry partners who submit a justified request. Conditions: ata may be used for meta-analyses, secondary analyses, or other ethically approved research purposes. Requests will be reviewed by the study’s data access committee. Approval depends on scientific merit, ethical considerations, and compliance with data use agreements. Where to obtain: By contacting Sharifeh Khasraji sh.khasraji@gmail.com Khasraji.sh@ajmus.ac.ir How to obtain: Submit a formal request with a brief proposal Review by data access committee (within 4 weeks) Sign a data-sharing agreement Data delivery via secure platform Comments:
public Sharifeh Khasraji
Ahvaz University of Medical Sciences
Karkheh Iran (Islamic Republic of) 6455153147 +98 61 3222 7890 sh.khasraji@gmail.com Ahvaz University of Medical Sciences scientific Marzieh Araban
Ahvaz Univesrity of Medical Sciences
Ahvaz Iran (Islamic Republic of) 6455153147 +98 61 3222 7890 araban62@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Consent to Participate in the Study Absence of hypothyroidism according to the student's health record Studying at a rural secondary school Not Participation in a Similar Educational Program Having a Smartphone no limit no limit Female Inability to communicate in Persian or Arabic Not residing in the village where the student is studying E03 Other hypothyroidism Behavior Behavior Intervention group: Received an educational program including two 30-minute in-person sessions and two weeks of daily SMS messages. The content focused on awareness, prevention, and healthy behaviors related to hypothyroidism. Sessions were conducted at school during regular hours. Control group: during the course of the study, no educational interventions were conducted for the control group, and they only received routine training. Change in the behavior scores about hypothyroidism prevention measured before and three months after the intervention. Timepoint: At baseline (before intervention) and 3 months after the intervention. Method of measurement: Researcher-developed structured questionnaire on hypothyroidism behavior. Change in the attitude scores about hypothyroidism prevention measured before and three months after the intervention. Timepoint: At baseline (before intervention) and 3 months after the intervention. Method of measurement: Researcher-developed structured questionnaire on hypothyroidism attitude. Change in the subjective norm scores about hypothyroidism prevention measured before and three months after the intervention. Timepoint: At baseline (before intervention) and 3 months after the intervention. Method of measurement: Researcher-developed structured questionnaire on hypothyroidism subjective norm. Change in the perceived behavioral control scores about hypothyroidism prevention measured before and three months after the intervention. Timepoint: At baseline (before intervention) and 3 months after the intervention. Method of measurement: Researcher-developed structured questionnaire on hypothyroidism perceived behavioral control. Change in the behavioral intention scores about hypothyroidism prevention measured before and three months after the intervention. Timepoint: At baseline (before intervention) and 3 months after the intervention. Method of measurement: Researcher-developed structured questionnaire on hypothyroidism behavioral intention. Change in knowledge score about hypothyroidism prevention measured before and three monthe after the intervention. Timepoint: At baseline (before intervention) and 3 months after the intervention. Method of measurement: Researcher-developed structured questionnaire on hypothyroidism knowledge. Ahvaz University of Medical Sciences Approved 2023-05-27 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences No. 23, Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)