Protocol summary

Study aim
the effect of training base on planned behavioral theory on the intention to use iron supplements and vitamin D
Design
the study was performed based on the theory of planned behavior (TPB) on 175 female adolescents in two groups of control (n=92) and intervention (n=85) without randomization and blinding. Data collection was conducted through researcher-made questionnaire based on the TPB, with a confirmed validity and reliability. The data were analyzed in the SPSS statistical software (v. 20) using descriptive and inferential methods. The Significance level was set at 0.05 in all the tests.The study population was selected through cluster random sampling technique. At first, lists of all schools (rural and urban) with seventh-grade classes were arranged. Subsequently, two schools were chosen from the rural areas, and two schools were selected from the urban regions as the intervention group. Not Blinded, Not randomized.
Settings and conduct
This study was conducted on the seventh-grade female in Gonabad city (a city in the southeastern province of Khorasan Razavi, Iran).
Participants/Inclusion and exclusion criteria
The inclusion criteria : seventh-grade studentship, Gonabad residence, willingness to participate in the study. The exclusion criteria: Having absentee at training sessions,
Intervention groups
In this intervention study, a nutritional and supplementary education training course was conducted for 4 sessions of 2 hours for students in the experimental group for a maximum of one month. The strategy of providing educational content focused on constructs of attitude, subjective norm and perceived behavior control. In addition, education content was provided for teachers, administrators and at least one parent.
Main outcome variables
After intervention program mean scores of All the constructs except the attitude in the intervention group were significantly higher than the control group (p <0.001).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180722040559N1
Registration date: 2018-10-03, 1397/07/11
Registration timing: retrospective

Last update: 2018-10-03, 1397/07/11
Update count: 0
Registration date
2018-10-03, 1397/07/11
Registrant information
Name
Alireza Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3851 4548
Email address
jafaria962@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-25, 1396/08/03
Expected recruitment end date
2017-11-23, 1396/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effect of educational intervention program based on the theory of planned behavior associated with iron and vitamin D supplementation on components the model on Gonabad female high school students.
Public title
Behavioral intention to use of vitamin D and iron supplements by adolescents: an application of the theory of planned behavior
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
seventh-grade studentship Gonabad residence willingness to participate in the study
Exclusion criteria:
Having one or more session absentee at training sessions Students who participated in the pre-test but were not present in the post-test changing their schools
Age
From 12 years old to 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 175
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
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Imam Khomeini street
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Approval date
2016-06-30, 1395/04/10
Ethics committee reference number
SDH/2/012

Health conditions studied

1

Description of health condition studied
use of vitamin D and iron supplements
ICD-10 code
Z72.4
ICD-10 code description
Inappropriate diet and eating habits

Primary outcomes

1

Description
knowledge
Timepoint
One month after the meeting and after the test made by questionnaire, the two groups will be measured
Method of measurement
questionnaire

2

Description
Attitude
Timepoint
One month after the meeting and after the test made by questionnaire, the two groups will be measured
Method of measurement
questionnaire

3

Description
Subjective norm
Timepoint
One month after the meeting and after the test made by questionnaire, the two groups will be measured
Method of measurement
questionnaire

4

Description
Perceived behavioral control
Timepoint
One month after the meeting and after the test made by questionnaire, the two groups will be measured
Method of measurement
questionnaire

5

Description
Intention
Timepoint
One month after the meeting and after the test made by questionnaire, the two groups will be measured
Method of measurement
questionnaire

Secondary outcomes

1

Description
behavioral intention
Timepoint
Baseline (pre-intervention) and one month after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: In the intervention group, education based on the theory of planned behavior was performed with 4 sessions of 120 minutes
Category
Prevention

2

Description
Control group: No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Education Schools in Gonabad
Full name of responsible person
Alireza Jafari
Street address
Gonabad University of Medical Sciences, Imam Khomeini street
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Phone
+98 51 5722 3514
Fax
Email
jafaria962@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Street address
Gonabad University of Medical Sciences, Imam Khomeini street
City
Gonabad
Province
Razavi Khorasan
Postal code
96917-93718
Phone
+98 51 5722 3514
Fax
Email
jafaria962@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Gonabad University of Medical Sciences
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Mashhad, Daneshgah Avenue, School of Health
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 38049
Email
jafaria962@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Position
phD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Mashhad, Daneshgah Avenue, School of Health
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 38049
Email
jafaria962@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Alireza Jafari
Position
phD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Mashhad, Daneshgah Avenue, School of Health
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 38049
Email
jafaria962@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Potential data is sharable after distinguishing people
When the data will become available and for how long
Start the access period one month after the publication of result
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data is sent through an official request and by email
From where data/document is obtainable
Alireza Jafari: jafaria962@mums.ac.ir
What processes are involved for a request to access data/document
Data is sent through an official request and by email
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