Determining the effect of educational intervention on the health literacy of female high school students in Fouladshahr in the field of iron deficiency anemia
Design
Clinical trial with intervention and control group (60 people in each group), unblinded, randomized by lottery method
Settings and conduct
Clinical trial with intervention and control group (60 people in each group), unblinded, randomized by lottery method
Participants/Inclusion and exclusion criteria
Female high school students living in Mehr Fouladshahr Maskan District who meet the following conditions: 1) 15 to 18 years old age group 2) Registration in second secondary schools in Mehr Fouladshahr Housing District 3) Informed and written consent of the student and one of the parents They are to participate in the study
Intervention groups
After selecting the samples, the researcher collects information about the intervention and control groups using a questionnaire. After analyzing the data, designing an educational program according to the interests of the students, analyzing the primary data, the conditions of the school and the opinion of the research team, and this will be decided during the research. In the next stage, the intervention group will be given the necessary training regarding health literacy and iron deficiency anemia. During this period, the control group does not receive any training. After the end of the educational intervention, according to the recommendation of scientific sources, the students will be given the opportunity to use the necessary training for one month, and after this time interval, we will provide the questionnaire to the same people again. to complete again. Finally, after two months of the educational intervention, the questionnaire will be given to the same people to complete the questionnaire.
Main outcome variables
Health literacy score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220925056037N1
Registration date:2023-04-08, 1402/01/19
Registration timing:prospective
Last update:2023-04-08, 1402/01/19
Update count:0
Registration date
2023-04-08, 1402/01/19
Registrant information
Name
Sahar Saeedi
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 31 5236 1363
Email address
sahar.saeedi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-14, 1402/01/25
Expected recruitment end date
2023-07-16, 1402/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention on the health literacy of secondary school girls in Fouladshahr in the field of iron deficiency anemia
Public title
The effect of educational intervention on the health literacy of secondary school girls in the field of iron deficiency anemia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Registering in second secondary schools of Fouladshahr Mehr Housing District
Age group of 15 to 18 years
Informed and written consent of the student and one of their parents to participate in the study
Exclusion criteria:
Age
From 15 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
After receiving the letter of recommendation from Tarbiat Modares University and obtaining a permit from the Vice-Chancellor of Health of Isfahan University of Medical Sciences, as well as with the coordination of the Fouladshahr Education Department, we will select the two schools of Resalat and Parvin Etisami, which are the only secondary schools in Mehr Fouladshahr housing area. And we randomly consider one of the schools as the intervention group (Parvin Etisami School) and one as the control group (Resalat School). Then, we randomly select 60 students from each of the schools (lottery method) as the sample size of each of the intervention and control groups.
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
Tarbiat Modares University (Research Ethics Committee)
Street address
Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Hamad and Chamran intersection,Tehran
City
Tehran
Province
Tehran
Postal code
14115-331
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.MODARES.REC.1401.182
Health conditions studied
1
Description of health condition studied
health literacy
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Iron deficiency anemia
ICD-10 code
D50
ICD-10 code description
Iron deficiency anemia
Primary outcomes
1
Description
The health literacy score in the researcher-made questionnaire
Timepoint
before the start of the study, one month and two months after the intervention
Method of measurement
researcher-made questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After receiving a letter of introduction from Tarbiat Modares University and obtaining a permit from the Vice-Chancellor of Health of Isfahan University of Medical Sciences and also with the coordination of Fouladshahr Education Department, 60 students of Parvin Etsami School (2nd secondary) who meet the study entry criteria We choose them randomly. After selecting the samples, the researcher introduces himself and the objectives of the research to the students and provides the necessary explanations about answering the questions, collects information using a questionnaire and collects them after completing the questionnaire. After analyzing the data, a suitable training program will be prepared by the researcher and according to the opinion of the research team. It should be noted that in the design and manner of holding educational sessions, students' interests, primary data analysis, the conditions of the school and respected teachers, and the opinion of the research team are considered, and this will be decided during the research. In the next stage, the intervention group will be given the necessary training regarding health literacy and iron deficiency anemia. After the end of the educational intervention, according to the recommendation of scientific sources, the students will be given the opportunity to use the necessary training for one month, and after this time interval, we will provide the questionnaire to the same people again. to complete again. Finally, after two months of the educational intervention, the questionnaire will be given to the same people to complete the questionnaire.
Category
Other
2
Description
Control group: After receiving a letter of introduction from Tarbiat Modares University and obtaining a permit from the Vice-Chancellor of Health of Isfahan University of Medical Sciences, as well as with the coordination of Fouladshahr Department of Education, 60 students of Resalat School (Second Secondary Section) who meet the entry criteria for our study are randomly selected. After selecting the samples, the researcher provides the necessary explanations regarding answering the questions for the students and collects them after completing the questionnaire. But in the future, we do not conduct any educational intervention for the control group, and finally, once after one month of the educational intervention we did for the intervention group, we give the questionnaires to the control group and again after two months. From the educational intervention of the intervention group, we give the questionnaires to the control group. It should be mentioned that the control group does not receive any intervention and only completes the questionnaires in certain time intervals.
Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Hamad and Chamran intersection,Tehran
City
Tehran
Province
Tehran
Postal code
331ـ14115
Phone
+98 21 8288 3827
Email
moussavi@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
100
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
Tarbiat Modares University
Full name of responsible person
Shamsuddin Niknami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Hamad and Chamran intersection,Tehran
City
Tehran
Province
Tehran
Postal code
14115-331
Phone
+98 21 8288 3549
Email
sahar98saeedi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Shamsuddin Niknami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Jalal Al Hamad and Chamran intersection,Tehran
City
Tehran
Province
Tehran
Postal code
14115-331
Phone
+98 21 8288 3549
Email
sahar98saeedi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Sahar Saeedi varnamkhasti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 52, Narges Alley, Vali Asr St., Shariati St.
City
Varnamkhast
Province
Isfehan
Postal code
8473158386
Phone
+98 31 5236 1363
Fax
Email
sahar98saeedi@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
This study is a thesis and its results will be published in the thesis and articles.
When the data will become available and for how long
This study is a thesis and its results are published in the thesis and articles.
To whom data/document is available
Apart from the personal and confidential information of the participants, which only the researcher has access to, other information is published in articles and theses.
In addition, people working in academic and scientific institutions can access the information by submitting a letter of introduction and coordinating with the responsible author of the article.
Under which criteria data/document could be used
This study is a thesis and definitive decisions in this field will be published in the future. In general, people who intend to use the results of this research in their studies should refer to our article or study as a source. Also, at each stage, check the necessary arrangements and more detailed instructions with the responsible author or other authors.
From where data/document is obtainable
To receive information, refer to the email address of the responsible author or other authors of the article.
What processes are involved for a request to access data/document
After sending a letter of introduction from the relevant institution to the email address of the responsible author of the article or the thesis supervisor (if she/he is not available, send an email to other authors), she/he will make the necessary arrangements with them.