Protocol summary

Summary
Goal: To determine the effects of an educational intervention on theoretical constructs of the social cognitive model and breakfast consumption behavior in girl students of Kavar city. Study design: educational field trial with control group Study. Population: all the Kavar high school students in grades of 7 and 8. Inclusion criteria: signing an informed consent form of participation by students and their parents, behavioral defect in breakfast consumption; and being in a physical health status. Exclusion criteria: failure to attend training sessions and withdrawal of the study. Sample size: the results of a primary pilot study in the target population revealed that more than 90% of students had impaired behavior on eating breakfast. So using a census method, the total of 406 students will be studied in the format of control (one school) or intervention (two schools) groups. Intervention: The training group includes students who never have breakfast or use less than two food groups (bread and cereals or milk and dairy products) for breakfast or breakfast meal provides less than 20% of their daily required energy. They will be instructed based on six fundamental constructs of social learning theory of Bandura (self-efficacy, social support, self-regulation, outcome expectancy and observational learning) in two months. The efficacy of the intervention will be assessed by comparing calorie intake and main constructs of the social learning theory.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061028378N1
Registration date: 2017-10-17, 1396/07/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
Kambiz Karimzadeh Shirazi
Name of organization / entity
Social determinants of health research center, school of health, Yasuj University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 74133220881
Email address
shirazi.kambiz@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2017-11-09, 1396/08/18
Expected recruitment end date
2018-01-09, 1396/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of an educational intervention based on the social cognitive theory on breakfast consumption behavior among female students in grades 7 and 8 attending middle schools
Public title
Improving the consumption of breakfast in students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: signing an informed consent form of participation by students and their parents, behavioural defect in breakfast consumption; and being in a physical health status. Exclusion criteria: failure to attend training sessions and withdrawal of the study.
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: 406
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
Yasuj University of Medical Sciences
Street address
Staff building, school of health, Dastjerdi avenue, Ostandari Square
City
Yasuj
Postal code
Approval date
2016-02-06, 1394/11/17
Ethics committee reference number
IR.YUMS.Rec.1394.145

Health conditions studied

1

Description of health condition studied
Behavioral defect in breakfast consumption
ICD-10 code
F98
ICD-10 code description
Other behavioural and emotional disorders with onset usually occurring in childhood and adolescence

Primary outcomes

1

Description
Calorie intake from breakfast
Timepoint
One week before and two weeks after the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Self-efficacy
Timepoint
One week before and two weeks after the intervention
Method of measurement
Questionnaire

2

Description
Social support
Timepoint
One week before and two weeks after the intervention
Method of measurement
Questionnaire

3

Description
Self-regulation
Timepoint
Before and 2 weeks after the intervention
Method of measurement
Questionnaire

4

Description
Outcome expectancy
Timepoint
Before and 2 weeks after the intervention
Method of measurement
Questionnaire

5

Description
Observational learning
Timepoint
Before and 2 weeks after the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: nutritional education for Proper consumption of the four food groups in breakfast, based on social cognitive theory constructs among students
Category
Behavior

2

Description
Control group: routine instructions for nutrition in schools
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Farhangian (Effat), Zeynab Kobra and Khadijeh Kobra middle schools
Full name of responsible person
Street address
City
Kavar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Hosein Mari Oriyad
Street address
Main building of Yasuj University of Medical Sciences, Shahid Motahari street
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj 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
Social determinants of health research center, school of health, Yasuj University of Medical Science
Full name of responsible person
Kambiz Karimzadeh Shirazi
Position
Academic member, PhD
Other areas of specialty/work
Street address
Staff building, school of health, Dastjerdi avenue, Ostandari Square
City
Yasuj
Postal code
Phone
+98 74133220881
Fax
Email
shirazi.kambiz@yums.ac.ir؛ karimzadehshirazi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Sciences, School of Health - Social Determinants of Health Research Cent
Full name of responsible person
Kambiz Karimzadeh Shirazi
Position
Academic member, PhD
Other areas of specialty/work
Street address
Staff building, school of health, Dastjerdi avenue, Ostandari square
City
Yasuj
Postal code
7591875114
Phone
+98 74133220881
Fax
Email
shirazi.kambiz@yums.ac.ir; karimzadehshirazi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Sciences, school of health
Full name of responsible person
Kambiz Karimzadeh Shirazi
Position
Faculty member, PhD
Other areas of specialty/work
Street address
Staff building, school of health, Dastjerdi avenue, Ostandari square, postal code 7591875114
City
Yasuj
Postal code
7591875114
Phone
+98 74133220881
Fax
+98 917 314 0423
Email
shirazi.kambiz@yums.ac.ir; karimzadehshirazi@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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