Protocol summary

Summary
It is a randomized controlled trial (RCT) study that will be implemented after the approval of the Council of Guilan University of Medical Sciences. The study population included 394 secondary school female students who are selected randomly. These students were from two schools which will be chosen as the control and the intervention schools. Samples were obtained 57 students in each group using the Pukak formula. Due to this study and the possibility of losing 10% of the samples was considered the sample size with 63 students per group. Methodology: Based on the validity and reliability will be performed the pretest among the experimental and control groups at schools and all the students in the elected class. Inclusion criteria include the student's satisfaction and the exclusion criteria study consist of miss more than one educational sessions. According to the results of the pretest will be to design and implement appropriate educational intervention and then, in order to compare and determine the intervention effect, the posttest will be taken among the intervention and control groups on one months after intervention. Data were collected using the Health Literacy Measure for Adolescents (HELMA) questionnaire. The questionnaire comprise range of questions to assess personal and interpersonal factors associated with health literacy for adolescents. The final questionnaire was approved with 44 items split into eight sections. The sections were titled: gain access to, reading, understanding, use, communication, self-efficacy and numeracy. The current study is the first attempt to design and psychometric to measure health literacy for Iranian adolescents which implement in both qualitative and quantitative sections.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201608131087N8
Registration date: 2017-05-08, 1396/02/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-08, 1396/02/18
Registrant information
Name
Rabiollah Farmanbar
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1552 0149
Email address
farmanbar@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the educational intervention on health literacy level in the girl students of the high School in Siahkal (2016-2017)
Public title
The effect of the educational intervention on health literacy level in the girl students of the high School in Siahkal (2016-2017)
Purpose
Health service research
Inclusion/Exclusion criteria
Includes all students in the second grade secondary day schools interested in participating in the study. Exclusion criteria: absence more than once in training sessions
Age
From 16 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 63
Randomization (investigator's opinion)
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
Guilan University of Medical Sciences
Street address
Gas Valves Vice Chancellor for Research and Technology
City
rasht
Postal code
Approval date
2016-10-30, 1395/08/09
Ethics committee reference number
IR.GUMS.REC.1395.292

Health conditions studied

1

Description of health condition studied
Health literacy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Health literacy
Timepoint
A period of one month after the intervention.
Method of measurement
HELMA questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The type of intervention is educational. After identifying the weaknesses in each of the sections, the educational intervention will be performing on any of them, and then, after one month, the questionnaires will be completed and evaluated again. The training will be in the form of lectures, discussions, brainstorming, poster, pamphlets and slides.
Category
N/A

2

Description
in the first phase, there will be no educational intervention in the control group after completing the questionnaire. In the second phase, the questionnaire will be completed with completing the questionnaire in the intervention group simultaneously.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Two Girls Secondary School II
Full name of responsible person
Street address
City
Siahkal

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology University of Medical Sciences
Full name of responsible person
Drshadman Nemati
Street address
Valves for gas - martyr Beheshti Boulevard West - Opposite Bank Sepah - Iran's top representative radiators - Construction Vice Chancellor for Research and Technology
City
rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht School of Public Health Rasht
Full name of responsible person
Mitra Kekhtari
Position
Graduate (masters) Student Health
Other areas of specialty/work
Street address
School of Public Health, Three road Palestinians
City
Rasht
Postal code
Phone
+98 13 3334 6593
Fax
Email
mitra.ketari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht School of Public Health
Full name of responsible person
Dr. Rabiollah Farmanbar
Position
Associate professor of Department of Health and Health Promotion
Other areas of specialty/work
Street address
School of Public Health, Three road Palestinians
City
Rasht
Postal code
Phone
+98 13 3382 5567
Fax
Email
rabi_1345@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rasht School of Public Health
Full name of responsible person
Mitra Kekhtari
Position
Masters student health education
Other areas of specialty/work
Street address
School of Public Health, Three road Palestinians
City
Rasht
Postal code
4144814955
Phone
+98 13 3334 6593
Fax
Email
mitra.ketari@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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