Protocol summary

Summary
This study was performed in 2011 to consider effectiveness of an educational intervention based on social cognitive theory on increasing consumption of fruit and vegetable among grade 4 students of Isfahan. In present study, 138 students were randomly divided to intervention and control group. Data of two groups were collected before and three months after educational intervention. A self-administered questionnaire based on constructs of social cognitive theory (including behavioral capability, outcome expectations, self-efficacy in difficult situations, self-efficacy in selecting fruit and vegetable, access to fruit and vegetable, social support, observational learning and preferences) and food record questionnaire were used for data gathering. Validity and reliability stages were accomplished for the tools. Theory-based nutrition education was performed for intervention group in 4 educational sessions (60 minutes per each session) during 4-week period for students and 2 educational sessions (50 minutes per each session) for parents and teachers. All students participated in this study voluntarily and with informed consent. Also, their families' consent was obtained.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108077251N1
Registration date: 2011-12-09, 1390/09/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-12-09, 1390/09/18
Registrant information
Name
Arash Najimi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1420 8372
Email address
a_najimi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Isfahan, Iran
Expected recruitment start date
2010-09-26, 1389/07/04
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of educational intervention based on social cognitive theory to promote fruit and vegetable consumption among elementary school students
Public title
Increasing consumption of fruit and vegetable in students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Satisfaction of students and their parents to participate in the study; third-grade students. Exclusion criteria: students who did not participate in one educational session; not following a special diet because of a disease.
Age
From 9 years old to 11 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 138
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
Isfahan University of Medical Sciences
Street address
School of health, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-02-20, 1388/12/01
Ethics committee reference number
288288

Health conditions studied

1

Description of health condition studied
Health
ICD-10 code
Z59.4
ICD-10 code description
Lack of adequate food

Primary outcomes

1

Description
Fruit consumption (Servings/day)
Timepoint
Before and 3 month after intervention
Method of measurement
Three days food record questionnaire

2

Description
Vegetable consumption (Servings/day)
Timepoint
Before and 3 month after intervention
Method of measurement
Three days food record questionnaire

Secondary outcomes

1

Description
Behavioral capability
Timepoint
Before and 3 month after intervention
Method of measurement
Questionnaire

2

Description
Outcome expectations
Timepoint
Before and 3 month after intervention
Method of measurement
Questionnaire

3

Description
Observational learning
Timepoint
Before and 3 month after intervention
Method of measurement
Questionnaire

4

Description
Self-efficacy
Timepoint
Before and 3 month after intervention Questionnaire
Method of measurement
Questionnaire

5

Description
Environmental factors
Timepoint
Before and 3 month after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention Group: Nutrition education based on social cognitive theory was implemented in 4 educational sessions (60 minutes per each session) during 4-week period for students, and 2 educational sessions (50 minutes per each session) for parents and teachers.
Category
Lifestyle

2

Description
Control Group: no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Third region in Isfahan
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Sharifirad
Street address
School of health, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Arash Najimi
Position
Msc of health education
Other areas of specialty/work
Street address
Department of Health promotion and Health education, School of Health, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8194953464
Phone
+98 31 1420 8372
Fax
Email
a_najimi@hlth.mui.ac.ir , najimiarash@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Arash Najimi
Position
MSc of health education
Other areas of specialty/work
Street address
Department of Health promotion and Health education, School of Health, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8194953464
Phone
+98 31 1420 8372
Fax
Email
a_najimi@hlth.mui.ac.ir
Web page address

Person responsible for updating data

Contact

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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