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The effect of counseling on health behaviors of adolescent girls inTabriz: a randomized controlled Field Trial

Protocol summary

Summary
The goal is to determine the effect of counseling on adolescent girls' health behaviors. Inclusion criteria: Students aged 18 to 14, students who have experienced menarche, have less pre-test scores. Exclusion criteria: having physical and mental illness, having a specific diet, having physical activity limits. Methods: This clinical trial will be carried out on 120 high school girl students in Tabriz. Sampling will be multistage clustering. Thus, out of a total of 180 school girls for ten schools (from each district of two schools) and 12 students from each school, they will be randomly selected. One school in each district will be randomly selected from the control group and the other school of intervention. Qualified students will complete demographic questionnaires, nutrition and physical activity questionnaires, menstrual health questionnaire, and social and economic status questionnaires. Individuals who have a lower pre-test score will be included in the study. Advice in the intervention group. Educational content will include proper nutrition, appropriate physical activity, and compliance with menstrual health. The counseling is training-based and will be carried out in three sessions for 45-60 minutes. The control group will not receive any intervention. Primary outcomes: Increasing the mean nutritional, physical activity and menstrual health scores 8 weeks after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052034052N1
Registration date: 2017-07-27, 1396/05/05
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-27, 1396/05/05
Registrant information
Name
Niloofar Sattarzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
sattarzadehn@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research, Tabriz University of Medical Science
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling on health behaviors of adolescent girls inTabriz: a randomized controlled Field Trial
Public title
The effect of counseling on health behaviors of adolescent girls
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Students aged 18 to 14 years; enrolled high school students who are educating; students who have experienced menarch; having willingness to participate in the study; having parents' permission to attend In the study; having a contact number to follow up; earning a pre-test scores less than a cut off. Exclusion criteria: having physical and mental illness; having a specific diet; having physical activity limitations.
Age
From 14 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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Regional Ehics Committee
Street address
Department of Research and Technology, third floor, Central Building, No. 2, Tabriz University of Medical Sciences, Golgasht,
City
Tabriz
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.TBZMED.REC.1396.177

Health conditions studied

1

Description of health condition studied
Persons encountering health services for other counselling and medical advice, not elsewhere classified
ICD-10 code
Z71.9
ICD-10 code description
Counselling, unspecified

Primary outcomes

1

Description
physical activity
Timepoint
Before intervention, 8 weeks after intervention
Method of measurement
IPAQ questionare

2

Description
nurition
Timepoint
Before intervention, 8 weeks after intervention
Method of measurement
FFQ questionare

3

Description
hygien mensturation
Timepoint
Before intervention, 8 weeks after intervention
Method of measurement
hygien mensturation questionare

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, counseling is done on a training-based basis. Educational content will include proper nutrition, appropriate physical activity, and compliance with menstrual health. Consultation takes place for up to 45 minutes in the relevant counseling room for three consecutive sessions. The number of participants in each session will be 10-8 people, and the last 20 minutes will be devoted to answering questions and answers. The content of the first session of puberty and menstruation is the content of the second session on nutrition and the third session of physical activity. The number of sessions will increase as needed. 8 weeks after the end of the intervention, the nutrition and physical activity (short form) and menstrual health questionnaire will be provided to the students and will be completed by the students.
Category
Lifestyle

2

Description
The control group will not receive any intervention. If the results of the research are positive, after the completion of the research, the training content will be provided to the control group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Education Department of East Azarbaijan province
Full name of responsible person
Jafar Pashaie
Street address
South Army Street, Police Station Street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of research, Tabriz University of Medical Science
Full name of responsible person
Dr. Mohammadreza Rashidi
Street address
3rd floor, Central building number 2, Tabriz University of Medical Science , Golgasht St.
City
tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Tabriz University of Medical Science
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
Tabriz University of Medical Science
Full name of responsible person
Raana Aghanezhad Nozari
Position
MSc Student of counseling in Midwifery
Other areas of specialty/work
Street address
End of Dr. Shariati Avenue, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3477 2699
Fax
Email
raana_nozari@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Niloofar Sattarzadeh
Position
PhD in reproductive health
Other areas of specialty/work
Street address
End of Dr. Shariati Avenue, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3477 2699
Fax
Email
sattarzadehn@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Raana Aghanezhad Nozari
Position
MSc Student of counseling in Midwifery
Other areas of specialty/work
Street address
End of Dr. Shariati Avenue, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+41 34772699
Fax
Email
raana_nozari@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir

Sharing plan

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