Protocol summary

Study aim
Determine the Impact of educational intervention based on the health belief model on physical puberty health behavior of girl students of 9th grade in public schools in Rasht city, in 2018
Design
Randomized controlled trial, the intervention group (49) and control group (49), with parallel groups, not blind, random cluster.
Settings and conduct
Four schools are randomly selected from the list of schools in Rasht and randomly assigned to the control and test groups.To prevent the transmission of control and test information, the selected schools are randomly selected at a distance. From each school, a class is selected in the form of a draw. According to the research criteria, In total, 98 female students of the 9th grade will be included in the test and control groups.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Employment at the ninth grade, having menarche experience (first menstruation). Exit criteria: physical and mental disability, not having satisfaction to participate in the study.
Intervention groups
Educational intervention program based on the health belief model will be carried out to improve the physical puberty health behavior of girl students. Before conducting the training classes, at first assessment will be based on the health belief model (pre-test) for the intervention and control group. Then, for intervention groups, 16 training sessions will be held between 45-60 minutes (for 4 subgroups of 12 people) and one month after the intervention, a reassessment based on the health belief model (post-test) will be performed for both intervention and control groups. In order to follow the ethical point of view, after the post-test, the training program for the control group is also conducted in two sessions.
Main outcome variables
Puberty health behavior

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181014041337N1
Registration date: 2018-12-21, 1397/09/30
Registration timing: prospective

Last update: 2018-12-21, 1397/09/30
Update count: 0
Registration date
2018-12-21, 1397/09/30
Registrant information
Name
Zahra Aghaee Kenari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 5058
Email address
aghaeezahra@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the educational intervention based on the health belief model on physical puberty health of girl students of 9th grade in public schools
Public title
Study of The effect of educational intervention based on health belief model on health-puberty girls
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Employment at the ninth grade Having menarche experience (first menstruation)
Exclusion criteria:
Having physical and mental disabilities not having satisfaction to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is clustered. At first, each class is given from 1 to 4 numbers and using random numbers table, two of the 1-4 randomly selected and assigned to the intervention classes.
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 Guilan University of Medical Sciences
Street address
Office center of Guilan University of Medical Sciences, Parastar Street, Rasht, IRAN
City
Rasht
Province
Guilan
Postal code
4157679466
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.Gums.REC.1397.240

Health conditions studied

1

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

Primary outcomes

1

Description
Puberty health behavior
Timepoint
Before the intervention and one month after the intervention.
Method of measurement
Validated questionnaire of health belief model constructs.

Secondary outcomes

1

Description
knowledge
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Validated questionnaire of health belief model constructs

Intervention groups

1

Description
Intervention group: educational intervention is organized in the form of holding educational classes based on the health belief model, in order to increase the awareness of puberty health behavior which includes 16 training sessions of 45-60 minutes for 4 subgroups of 12 people.Training is based on educational methods such as lectures, group discussions, role play, rewarding, and educational tools such as tracks, pamphlets, and powerpoint slides.Evaluation is based on the health belief model before the intervention and one month after the intervention.
Category
Behavior

2

Description
Control group: This group will not receive educational intervention and assessment will be done based on the health belief model in this group before and one month after the intervention. In order to follow the ethical point of view, after the post-test, the training program for the control group is also performed in two sessions.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Education of Guilan Province
Full name of responsible person
Dr. Nader Jahan Ara
Street address
Farhang Square، Rasht، Gilan Province
City
Rasht
Province
Guilan
Postal code
4157679466
Phone
+98 13 3332 9082
Email
medu@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Street address
Opposite of 17 Shahrivar Hospital، Shahid Siadati Ave، Namjo Ave، Rasht
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
nemati@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Zahra Aghaee Kenari
Position
MSc Student of Health Education and promotion
Latest degree
Bachelor
Other areas of specialty/work
Family Health
Street address
School of Health, Resalat street, Rasht
City
Rasht
Province
Guilan
Postal code
418879755
Phone
+98 13 3332 3538
Email
aghaeezahra@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Parisa Kasmaee
Position
Associate Professor of Health Education and promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Health, Resalat street, Rasht
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3384 9412
Email
parisak81@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Aghaee Kenari
Position
MSc Student of Health Education and promotion
Latest degree
Bachelor
Other areas of specialty/work
Family Health
Street address
School of Health, Resalat street, Rasht
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3332 3538
Email
aghaeezahra@gums.ac.ir

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
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