Determination the effect of the educational program on healthy and safe nutrition behaviors of girl's students using health action model
Design
The sample size is determined after a pilot study on a small sample of the target group and the sampling is done by multi-stage random cluster and districts, schools and classes are selected randomly Simple with random numbers table.
Settings and conduct
Research is conducted in girls' government schools. After completing the consent form, a pre-test is performed in two groups of intervention and control with a questionnaire. Then the intervention is presented only in the intervention group. Two months after the end of the intervention, post-test is done in both groups.
Participants/Inclusion and exclusion criteria
The desire of eighth- grade girl's students of Governmental schools of Shiraz city to participate in the study
Intervention groups
In order to promote the nutritional behaviors of students in the intervention group, an educational program based on content designed using interactive methods in educational sessions is implemented. In addition, the pamphlet includes the key points related to the final conclusion of the topics discussed in each training session is provided and will be given to the students. After the end of the study, the educational content is placed available in the control group.
Main outcome variables
The main outcomes of this study contains to determine the predictive variables of healthy and safe nutrition behavior in girls students and to determine and compare the mean scores of health action model of constructs such as belief systems, motivational, normative, Self (personality), behavioral intention, facilitating or enabling factors and health action behavior in the context of healthy and safe nutrition behavior of girls students in both intervention and control groups before and after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041100N1
Registration date:2018-10-24, 1397/08/02
Registration timing:registered_while_recruiting
Last update:2018-10-24, 1397/08/02
Update count:0
Registration date
2018-10-24, 1397/08/02
Registrant information
Name
Leila Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 7799
Email address
lmoradi20072007@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and Evaluation of the Promotion Healthy and Safe Nutrition Behaviors Program in High School Female Students Using Health Action Model
Public title
Promoting Nutritional Behaviors in Students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Eighth grade girl's students
They are studying in governmental high schools in Shiraz.
Students tend to participate in the study.
Exclusion criteria:
Unwillingness to cooperate
Not attending in the training sessions more than 2 sessions
Not attending in the post-test
Exit from the study due to a transfer of students from the school, leave the school or immigration from Shiraz.
Age
From 14 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Multi-stage random cluster sampling is performed. In the first stage, from four districts of educational, two districts are selected randomly Simple. In the next stage, randomly simple, two Governmental girls' high schools are selected from each district. A school is considered as an intervention group and another school is considered as the control group and is selected from two districts of four schools. In the final stage, two classes of the 8th grade from each school are selected randomly Simple. A total of 4 classes of the 8th grade are placed in the intervention group and 4th classes of the 8th grade are placed in the control group. A random numbers table is used to select randomly Simple.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee in Biomedical Research
Street address
School of Public Health, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
035- 38209119
Approval date
2018-09-24, 1397/07/02
Ethics committee reference number
IR.SSU.SPH.REC.1397.071
Health conditions studied
1
Description of health condition studied
Design and Evaluation of Promoting Healthy and Safe Nutrition Behaviors Program in High School Girls Students Using Health Action Model
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determine and compare the mean score of healthy and safe nutrition behavior of girl's students in two groups of intervention and control before and after intervention
Timepoint
At the beginning of the study (before the intervention) and 2 months after the end of the intervention.
Method of measurement
Researcher-made Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention is an educational type that is implemented in intervention group students to promote healthy and safe nutrition behaviors. An educational program based on educational content designed using interactive methods in educational sessions will be implemented. In addition, the pamphlet contains key points related to the final conclusion of the topics discussed in each training session is provided and will be given to the students.
Category
Lifestyle
2
Description
Control group: High school girl students in Shiraz schools who do not receive any interventions.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Governmental High Girls Schools of Shiraz City
Full name of responsible person
Leila Moradi
Street address
No. 16, Alley 5, Qasr- Dasht Avenue, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
0098717133873757
Phone
+98 71 3233 7799
Email
lmoradi20072007@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masoud Mirzaei
Street address
Yazd - Bahonar Square, First of Shahid Sadoughi South Avenue. Central University Building, Third Floor, Department of Research and Technology
City
Yazd
Province
Yazd
Postal code
035-31462136
Phone
+98 35 3726 3733
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Leila Moradi
Position
Ph.D. student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No. 16, Alley 5, Qasr- Dasht Avenue, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
0098717133873757
Phone
+98 71 3233 7799
Email
lmoradi20072007@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Morowatisharifabad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
School of Public Health, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
035-38209119
Phone
+98 353820910014
Email
morowatisharif@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Leila Moradi
Position
Ph.D. student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No. 16, Alley 5, Qasr- Dasht Avenue, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
0098717133873757
Phone
+98 71 3233 7799
Email
lmoradi20072007@yahoo.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some of the data and documentation listed in above can be shared.
When the data will become available and for how long
Start the access to documentation, 3 months after the publication of the article
To whom data/document is available
Researchers that working in academic and scientific institutions
Under which criteria data/document could be used
The provision of documentation and data files is with condition that there is no interference in the data and documentation of the study without the consent of the researcher.
From where data/document is obtainable
Dr. Mohammad Ali Morowatisharifabad, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran, Email:morowatisharif@yahoo.com
Leila Moradi, School of Health, Shiraz University of Medical Sciences, Iran, Email: lmoradi20072007@yahoo.com
What processes are involved for a request to access data/document
Send the email to the persons listed above and to review request the applicant and to provide information within a maximum of one month.