Protocol summary

Summary
The purpose of this study was to improve fruit and vegetable consumption in children. This study is an experimental intervention study. Participants are selected from the fourth, fifth and sixth grade students. The main inclusion criteria are: being school student in fourth, fifth and sixth grade; students and parents consent to participate in the study and Exclusion criteria are: consumption more than 5 units of the fruit and vegetables per day or lack of consent. Sample size for this study was 63 students for per group. Consider that a possibility loss of 20%, 76 samples chose for each group. After selecting the intervention and control groups, the data is collected in two stages: the first stage of data collection is before intervention and the second stage was two months after the intervention. Data gathered using a general questionnaire, a 24-hour recall questionnaire, a food frequency questionnaire and questionnaire designed based on the theory of planned behavior. Intervention includes a 1-hour educational session for parents, teachers and administrators and 4 educational sessions of 45 minutes for the students. The interested outcome of the study was the consumption rate of the fruit and vegetable before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307157352N8
Registration date: 2013-09-15, 1392/06/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-09-15, 1392/06/24
Registrant information
Name
Mohammad Hossein Taghdisi
Name of organization / entity
Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 7674
Email address
m-taghdisi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
center for community based participatory research, Tehran university of medical science
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intervention based on the theory of planned behavior (TPB) on fruit and vegetable consumption rate in elementary school male students in Chaldoran 2012-2013
Public title
Impact of education on fruit and vegetable consumption in children
Purpose
Prevention
Inclusion/Exclusion criteria
The main criteria of inclusion in the study are: School in fourth grade, fifth and sixth grade; students and parents consent to participate in the study . Exclusion criteria are: consumption more than 5 unite of fruit and vegetables a day; Lack of consent from study
Age
From 10 years old to 12 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 152
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
Tehran University of Medical Sciences
Street address
Sixth Floor، Central University، St. Ghods، Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2013-08-04, 1392/05/13
Ethics committee reference number
896 /130/د/92

Health conditions studied

1

Description of health condition studied
Fruit and vegetable consumption
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fruit and vegetable consumption
Timepoint
Before and two months after the intervention
Method of measurement
Fruit and vegetable food frequency questionnaire and24-hour recall2-Cognitive- attitudinal Questionnaire

Secondary outcomes

1

Description
Behavioral intention, attitude, subjective norms, and perceived behavioral control
Timepoint
Before and two months after the intervention.
Method of measurement
Cognitive assessment questionnaire

Intervention groups

1

Description
Education was used as intervention in this study. Intervention included a 1-hour educational session for parents, teachers and administrators and 4 educational sessions of 45 minutes for the students. Stage of the intervention: 1- The first phase of the intervention was training parents about the importance and role of fruit and vegetable consumption in physical health. Also to support parents and to encourage students to eat fruits and vegetables. At the end, parents received an educational pamphlet about the importance of eating fruits and vegetables. 2- The second stage of intervention was to train teachers and school administrators. 3- The third stage of intervention was to teach students using the information obtained from questionnaires. To this end, the most important predictors of behavior (eating enough daily fruits and vegetables) were identified and were used to design a training program.
Category
Other

2

Description
The control group: We did not intervene in control group; however, control subjects received educational pamphlets at the end of the study.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Education
Full name of responsible person
Doctor Mohammad Hussein Taghdisi
Street address
The education of Chaldoran، Moallem Square، Chaldoran، West Azerbaijan
City
Chladoran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
center for community based participatory research, Tehran university of medical sciences
Full name of responsible person
Esmat Karimi
Street address
Tehran، Ghods street،Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
center for community based participatory research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Doctor Mohamed hussein Taghdisi
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Health Education and Promotion، Faculty of Health، Tehran University of Medical Sciencesٰ، Ghods Street، Tehran
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
taghdisi-mh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Doctor Mohammad hussein Taghdisi
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Health Education and Promotion، Faculty of Health، Tehran University of Medical Sciencesٰ، Ghods Street، Tehran
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
taghdisi-mh@gmail.com
Web page address
.

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Towhid Babazadeh
Position
Master of Health Education
Other areas of specialty/work
Street address
Department of Health Education and Promotion، Faculty of Health، Tehran University of Medical Sciencesٰ، Ghods Street، Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
towhid.babazadeh@live.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
Loading...