Protocol summary

Study aim
1) Comparison of the frequency distribution of students in the intervention groups and comparison in terms of demographic variables before the intervention 2) Determining and comparing the average scores of knowledge, outcome expectations, self-efficacy, self-control, social support and behavior of students in the field of puberty health, before and after the educational intervention, within and between the intervention and comparison groups.
Design
A semi-experimental study has an experimental group and a control group, without blinding, randomized (lottery), the study phase does not exist.
Settings and conduct
Field of training: pubertal health, place of implementation: 4 high schools for girls in Ganaveh city, method of work: training of peer educators during four training sessions, completion of pre-test questionnaire in both experimental and control groups, implementation of different educational intervention in two groups, completion of post-test questionnaire Test, entering information from questionnaires into spss software and analyzing the results
Participants/Inclusion and exclusion criteria
Entry requirements: resident of Ganaveh, 11th grade student, agree to participate in the study, complete the informed consent form Conditions of non-entry: non-agreement to participate in the study, the presence of severe physical or psychological problems in the student
Intervention groups
1) 8 sessions of peer-guide training based on cognitive-social theory during two months in the experimental group 2) 8 regular training sessions (outside the framework of theory and without the leadership of peer trainers) in the control group
Main outcome variables
knowledge, outcome expectations, self-efficacy, self-control, social support, behavior

General information

Reason for update
Acronym
-
IRCT registration information
IRCT registration number: IRCT20211222053487N1
Registration date: 2022-09-18, 1401/06/27
Registration timing: prospective

Last update: 2022-09-18, 1401/06/27
Update count: 0
Registration date
2022-09-18, 1401/06/27
Registrant information
Name
Khadije Rezvany
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3314 3908
Email address
khvany1368@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-01-05, 1401/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of the peer-guide educational model based on social-cognitive theory and regular education on health-related behaviors and its determinants in high school girls.
Public title
Investigating the effect of peer-guide educational intervention based on cognitive-social theory on behaviors related to puberty health and its determinants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
11th grade student Resident of Gnave city Consent to participate in the study Completing the informed consent form
Exclusion criteria:
Failure to agree to participate in the study Having a severe physical or psychological problem in the student
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shiraz University of Medical Sciences
Street address
Administration Building، University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-07-03, 1401/04/12
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1401.055

Health conditions studied

1

Description of health condition studied
Puberty health behavior
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Puberty health related behavior score
Timepoint
At the beginning of the study (before the start of the intervention) and one month after the end of the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Knowledge score related to pubertal health
Timepoint
At the beginning of the study (before the start of the intervention) and one month after the end of the intervention
Method of measurement
Questionnaire

2

Description
Puberty health-related outcome expectations score
Timepoint
At the beginning of the study (before the start of the intervention) and one month after the end of the intervention
Method of measurement
Questionnaire

3

Description
Self-efficacy score related to puberty health
Timepoint
At the beginning of the study (before the start of the intervention) and one month after the end of the intervention
Method of measurement
Questionnaire

4

Description
Self-control (self-regulation) score related to pubertal health
Timepoint
At the beginning of the study (before the start of the intervention) and one month after the end of the intervention
Method of measurement
Questionnaire

5

Description
Social support score related to pubertal health
Timepoint
At the beginning of the study (before the start of the intervention) and one month after the end of the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: 120 11th grade female students in Ganaveh city; Iran. Puberty health training based on peer-leader technique during 8 sessions of 45 minutes for one month; Application of cognitive-social theory
Category
Behavior

2

Description
Control group: 120 11th grade female students in Ganaveh, Iran. Regular education (outside the framework of peer-guide technique and cognitive-social theory) puberty health during 8 sessions for one month
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Kausar Girls' High School
Full name of responsible person
Samanbar Javideh
Street address
Pasdaran Street
City
Genaveh
Province
Boushehr
Postal code
7731742256
Phone
+98 77 3312 3526
Email
khvany1368@gmail.com

2

Recruitment center
Name of recruitment center
Hijab Girls' High School
Full name of responsible person
Soghra Tolideh
Street address
Islamic Republic Street
City
Genaveh
Province
Boushehr
Postal code
7531734459
Phone
+98 77 3313 2480
Email
khvany1368@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Zand st.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
memarpour@sums.ac.ir
Web page address
https://www.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Khadije Rezvany
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Number 402, Baba Alishah neighborhood, Piroozi street., Ganave city
City
Genaveh
Province
Boushehr
Postal code
7531947893
Phone
+98 77 3314 3908
Fax
Email
khvany1368@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Kaveh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Administrative Building, University of Medical Sciences, Zand Street, Shiraz, Ira
City
Shiraz
Province
Boushehr
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
Email
Mhkaveh255@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadije Rezvany
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 402, Baba Alishah Quarter, Piroozi Street, Ganaveh City
City
Genaveh
Province
Boushehr
Postal code
7531947893
Phone
+98 77 3314 3908
Fax
Email
khvany1368@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Loading...