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
Investigation the impact of an educational intervention based on the Theory of Planned Behavior on preventing hypothyroidism in rural adolescent girls.
Design
A randomized, controlled, parallel group trial with 326 participants (153 intervention, 173 control). Randomization is done using computer-generated. The intervention includes two face-to-face sessions and two weeks of SMS education, followed by a 3-month follow-up. Conducted in 2023-2024.
Settings and conduct
The trial was conducted in Karkheh, Iran, in 2023-2024. Participants were selected from local high schools. The intervention group received two face-to-face sessions and daily SMS messages. The control group received standard education. Data were collected at baseline and three months later.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Informed consent No hypothyroidism Enrolled in a rural secondary school Owns a smartphone Resides in the study village
Exclusion Criteria: Missing two sessions Relocated or inaccessible Incomplete questionnaire responses
Intervention groups
This study include an intervention and a control group. The intervention group receives two 30-minute sessions and daily SMS messages for two weeks on hypothyroidism prevention. The control group receives routine care without additional education.
Main outcome variables
Awareness: Knowledge of hypothyroidism and prevention before and after the intervention. Attitude: Participants' beliefs about hypothyroidism prevention.
Subjective Norms: Perceived social pressure regarding prevention. Perceived Behavioral Control: Self-perception of ability to prevent hypothyroidism.Behavioral Intentions: Intent to adopt preventive behaviors.
Actual Behavior: Changes in behavior related to prevention after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250327065163N1
Registration date:2025-06-08, 1404/03/18
Registration timing:retrospective
Last update:2025-06-08, 1404/03/18
Update count:0
Registration date
2025-06-08, 1404/03/18
Registrant information
Name
Sharifeh Khasraji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 992 288 0755
Email address
khasraji.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
2023-10-23, 1402/08/01
Actual recruitment end date
2024-03-19, 1402/12/29
Trial completion date
2024-03-19, 1402/12/29
Scientific title
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
Public title
How Can Education Help Prevent Hypothyroidism in Rural Teenage Girls?
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Inability to communicate in Persian or Arabic
Not residing in the village where the student is studying
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
353
Actual sample size reached:
326
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 23, Golestan Blvd., Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-05-27, 1402/03/06
Ethics committee reference number
IR.AJUMS.REC.1402.128
Health conditions studied
1
Description of health condition studied
Hypothyroidism and its prevention in teenager students
ICD-10 code
E03
ICD-10 code description
Other hypothyroidism
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Behavior
2
Description
Control group: during the course of the study, no educational interventions were conducted for the control group, and they only received routine training.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Rural High Schools of Karkheh County
Full name of responsible person
Sharifeh Khasraji
Street address
Iran, Khouzestan, Karkheh
City
Karkheh
Province
Khouzestan
Postal code
00000000
Phone
+98 21 0000 0000
Email
sh.khasraji@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Abdollah Rafiei
Street address
Ahvaz University of Medical Sciences
City
Karkheh
Province
Khouzestan
Postal code
6455153147
Phone
+98 61 3222 7890
Email
sh.khasraji@gmail.com
Grant name
research and technology deputy of ahvaz jundishapur university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sharifeh Khasraji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Ahvaz University of Medical Sciences
City
Karkheh
Province
Khouzestan
Postal code
6455153147
Phone
+98 61 3222 7890
Email
sh.khasraji@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzieh Araban
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Ahvaz Univesrity of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6455153147
Phone
+98 61 3222 7890
Email
araban62@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sharifeh Kharasji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Ahavaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6455153147
Phone
+98 61 3222 7890
Email
Kharasji.sh@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 become available and for how long
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 data/document is available
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.
Under which criteria data/document could be used
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.
From where data/document is obtainable
By contacting Sharifeh Khasraji
sh.khasraji@gmail.com
Khasraji.sh@ajmus.ac.ir
What processes are involved for a request to access data/document
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