Objective: To investigate the effect of educational interventions based on social cognitive theory on dietary behaviors in adolescent girls.
Study design: This study will be a single blind randomized controlled trial
Population: Eligible participants in this study will be all student girls in grade 6 and 7 in two public elementary schools, their parents and teachers.
Inclusion criteria will adolescents living in Isfahan city and don’t have allergy, chronic diseases or disabilities that interfere with interventions.
Exclusion criteria: Students or teachers that plan to leave the school during the study and students, parents or teachers who do not participate in one educational session will subsequently exclude from study.
Sample size:The study aimed to recruit 230 participants. Therefore, 115 students will be required in each of the two groups.
Interventions:educational interventions including adolescents, parents and teachers nutrition education. parents and teachers involvement in education and social support.
Time of intervention: Academic year(2016-2017)
Outcomes: behavioral mediators and nutrition behaviors including breakfast consumption,snack and fastfood consumption and fruit and vegetable consumption in adolescent girls.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607052857N2
Registration date:2016-07-27, 1395/05/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-27, 1395/05/06
Registrant information
Name
Ashraf Kazemi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2939
Email address
kazemi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of school-based educational interventions on nutrition behaviors of adolescents girls based on social cognitive theory
Public title
The effect of health education on adolescent nutrition behavior
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Eligible participants in this study will be all student girls in grade 6 and 7 in Isfahan public elementary schools, and living in Isfahan or suburb area of Isfahan, Youth should be mentally healthy and don’t have allergy, chronic diseases or disabilities that interfere with interventions. Teenage mother or in the absence of the mother, who is in charged with the task of keeping youth, participates in sessions. Exclusion criteria: Students or teachers that plan to leave the school during the study and students, parents or teachers who do not participate in one educational session or will subsequently exclude from study.
Age
From 12 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
230
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical sciences
Street address
Isfahan-Hezar jarib
City
Isfahan
Postal code
Approval date
2015-06-21, 1394/03/31
Ethics committee reference number
Ir.mui.rec.1394.3.335
Health conditions studied
1
Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
knowledge
Timepoint
before intervention,3 and 6 month after intervention
Method of measurement
questionnaire
2
Description
self-efficacy
Timepoint
before intervention,3 and 6 month after intervention
Method of measurement
questionnaire
3
Description
intention
Timepoint
before intervention,3 and 6 month after intervention
Method of measurement
questionnaire
4
Description
social support
Timepoint
before intervention,3 and 6 month after intervention
Method of measurement
questionnaire
5
Description
self-regulation
Timepoint
before intervention,3 and 6 month after intervention
Method of measurement
questionnaire
6
Description
outcome expectations and expectancies
Timepoint
before intervention,3 and 6 month after intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
breakfast consumption
Timepoint
before intervention,3 and 6 month after intervention
Method of measurement
questionnaire
2
Description
snacking
Timepoint
before intervention,3 and 6 month after intervention
Method of measurement
questionnaire
3
Description
fruit and vegetable consumption
Timepoint
before intervention,3 and 6 month after intervention
Method of measurement
questionnaire
4
Description
fastfood consumption
Timepoint
before intervention,3 and 6 month after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
adolescents, parents and teahers will recieve educational program. Adolescents education class contains 8 sessions of 60 minutes each over eight weeks period. adolescents will recieve participatory homeworks too. Sessions are planned to develop healthy nutrition behaviors including: Small group presentations, Facilitated discussion, Trigger films, Develope discussion, Provide successful examples of adolescents and Guided goal setting activities.Parents and teachers education package will be delivered through two workshops for parents and teachers separately through Lectures and pamphlets and SMS to improve social support for adolecents which is considered in social cognitive theory.
Category
Behavior
2
Description
The control group will continue to receive standard government routine health education by health teachers. Routine health education offers education to students during monthly class contacts and don’t have nutritional education sessions for parents and teachers.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
public elementary schools for girls
Full name of responsible person
Morvarid Ghasab Shirazi
Street address
Nursing and Midwifery school.Isfahan university of medical sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan university of medical sciences
Full name of responsible person
Dr Mohamad Hashemi
Street address
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
Vice Chancellor for research of 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
MORVARID gHASAB Shirazi
Position
PhD Candidate Student Reproductive Health
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 7533
Fax
Email
morvashirazi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Morvarid Ghasab Shirazi
Position
PhD Candidate Student Reproductive Health
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 7533
Fax
Email
morvashirazi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Morvarid Ghasab Shirazi
Position
PhD Candidate Student Reproductive Health
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)