Protocol summary

Study aim
1- Determining the effect of nutrition education based on the principles of Iranian health care on the nutritional performance of students 2- Determining the Effect of Nutrition Education Based on the Principles of Health Protection of Iranian Medicine on Anthropometric Indices of Students 3 - Determine the level of knowledge, attitude and nutritional behavior of students before and after intervention
Design
A field trial to examine the effect of the educational package of the principles of nutrition in Iranian medicine using the Pender Health Promotion Model that will be implemented on target group students. In this study, boy students in Mashhad Middle schools who are eligible to enter the study will be selected by multi-stage method (cluster-random sampling).
Settings and conduct
This study will be conducted in the midle schools of Mashhad and in coordination with the Education Department of Mashhad. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mashhad schools healthy students with overweight or obesity who are studying at the seventh to ninth grade.
Intervention groups
Intervention group: In this group, the necessary training based on the educational package of the principles of nutrition in Iranian Traditional medicine based on the Pender Health Promotion Model will be provided to the students of the intervention group. Control group: In this group, anthropometric indices are measured at the beginning of the intervention, one month and three months after the intervention without any educational intervention.
Main outcome variables
Anthropometric indices including height, weight, BMI, waist circumference, and anthropometric measurements with bioimpedance device

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171005036570N1
Registration date: 2018-10-12, 1397/07/20
Registration timing: retrospective

Last update: 2018-10-12, 1397/07/20
Update count: 0
Registration date
2018-10-12, 1397/07/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8931
Email address
abdollahzadehh1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-10-02, 1397/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of nutritional education 'based on the principles of health protection of Iranian traditional medicine' on the nutritional performance and anthropometric indices of students
Public title
The effect of Iranian medicine education on nutritional behavior of students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male students Seventh to Ninth grade From Mashhad's schools Overweight or obesity without Underlying disease
Exclusion criteria:
Lack of overweight or obesity Underlying disease Parental dissatisfaction
Age
From 12 years old to 15 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Multi-stage (cluster-random sampling)
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Organization of Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9188965395
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.MUMS.REC.1397.092

Health conditions studied

1

Description of health condition studied
Overweight and Obesity in students
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
z score of BMI to weight ratio
Timepoint
The first turn is before the study and the second time after the end of the study and the third time is three months after the end of the educational intervention.
Method of measurement
Hour meter, balance

2

Description
Body fat
Timepoint
The first turn is before the study and the second time after the end of the study and the third time is three months after the end of the educational intervention.
Method of measurement
Bio-impedance device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, the necessary training based on the educational package of the principles of nutrition in Iranian Traditional medicine based on the Pender Health Promotion Model will be provided to the students of the intervention group. Anthropometric indices are measured at the beginning of the intervention, one month and three months after the intervention.
Category
Prevention

2

Description
Control group: In this group, anthropometric indices are measured at the beginning of the intervention, one month and three months after the intervention without any educational intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Alavi school
Full name of responsible person
Seyed Mohammad Reza Alavi Bijestani
Street address
No. 136,Between Sadeghi 12 and 14, Shahid Sadeghi Blvd.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9881438993
Phone
+98 51 3760 0390
Email
alavi.seyedmahmood@gmail.com

2

Recruitment center
Name of recruitment center
Be'sat school
Full name of responsible person
Madadian
Street address
Sattari 13 - Shahid Sattari Crossing -Moallem Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9881213333
Phone
+98 51 3866 2094
Email
besat@gmail.com
Web page address
http://besat-r.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Central building of Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3841 2081
Email
tafaghodi@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Hassan Abdollahzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian and Complementary Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Fax
+98 51 3882 9279
Email
abdollahzadehh1@mums.ac.ir
Web page address
http://tim.mums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Hassan Abdollahzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian and Complementary Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
abdollahzadehh1@mums.ac.ir
Web page address
http://tim.mums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Hassan Abdollahzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Iranian and Complementary Medicine, University of Pardis, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Fax
+98 51 3882 9279
Email
abdollahzadehh1@mums.ac.ir
Web page address
http://tim.mums.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
Yes - There is 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
Title and more details about the data/document
The results of a clinical study report will be published as an article in ISI journals.
When the data will become available and for how long
After publishing articles in medical journals
To whom data/document is available
Only as articles published in medical journals
Under which criteria data/document could be used
In order to use in researches and citation in papers
From where data/document is obtainable
abdollahzadehh1@mums.ac.ir
What processes are involved for a request to access data/document
Send an email to the researcher
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