The aim of this study is to determine the effect of nutrition education on reducing the consumption of unhealthy snacks among primary school students.
Design
The current research is a randomized clinical trial that will conducted by multi-stage random sampling method in primary school students in two test and control groups (120 samples) in schools.
Settings and conduct
The study population will include all students of the fourth, fifth and sixth grades of Elvand city. Two schools (n=60) will be assigned to the educational intervention group and two schools (n=60) will be assigned to the control group. Then, the educational intervention based on the structures of the stages of change is carried out during five sessions through face-to-face training, training through virtual space for the participants of the intervention group. Finally, the scores of the questions related to the meta-theoretical model before and after the training will be compared in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having physical and mental readiness, and ability to participate in the study, studying in government schools. Exclusion criteria: Students who have a special disease that prevents them from participating properly in the study.
Intervention groups
The educational intervention includes four sessions (one session per week) for 60-90 minutes by the researcher. Also a training session for parents as secondary target group. The educational methods will include lectures, slides, video and photo shows, group discussions, brainstorming, and question and answer. The control group received routine training by a nutritionist during the intervention.
Main outcome variables
Awareness, behavior change process, cognitive process and reduction of consumption of unhealthy snacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221211056776N1
Registration date:2023-06-13, 1402/03/23
Registration timing:retrospective
Last update:2023-06-13, 1402/03/23
Update count:0
Registration date
2023-06-13, 1402/03/23
Registrant information
Name
Bahareh Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3222 7951
Email address
rataarya@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-17, 1402/01/28
Expected recruitment end date
2023-04-27, 1402/02/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of theory-based educational intervention on consumption of healthy snacks in elementary students
Public title
The effect of nutritional education in the fourth, fifth and sixth grade of elementary school students to reduce the consumption of unhealthy snacks
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being students in the fourth, fifth and sixth grades of elementary school who live in the study area
Willingness and satisfaction of students and their parents to participate in the study
Being in the three stages of preparation for change, i.e. pre-thinking, thinking and preparation (according to the answers given to the algorithm of the stages of change)
Having a smart mobile phone by the student or parents to send educational messages or virtual training if needed
Exclusion criteria:
Unwillingness to continue participating in the study
Unavailability of the student when completing the post-test questionnaire (immigration during the research).
Suffering from physical and mental disorders and diseases that somehow prevent proper participation in the study. (Certified by a physician).
Age
From 9 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Cluster randomization method will be used. In this way, 2 schools will be assigned as intervention and two schools will be assigned as control.
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
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2023-03-18, 1401/12/27
Ethics committee reference number
IR.QUMS.REC.1401.370
Health conditions studied
1
Description of health condition studied
Consumption of healthy snacks in elementary students
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stages of behavior change
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
2
Description
The process of behavior change
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
3
Description
Cognitive process
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
4
Description
Knowledge
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
5
Description
Dramatic relief
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
6
Description
Timepoint
Method of measurement
7
Description
Social release
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
8
Description
Reciprocal conditioning
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
9
Description
Supportive relationships
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
10
Description
Balance in decision making
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
11
Description
Efficacy
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
12
Description
Consumption of healthy snacks
Timepoint
Consumption of healthy snacks
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Parents' education
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
2
Description
Parents'jop
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
3
Description
Age
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
4
Description
sex
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
5
Description
Student's weight
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
6
Description
Number of household dimensions
Timepoint
Before the intervention, one months after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Direct training with questions & answers in the intervention group for four weeks
Category
Behavior
2
Description
Control group: without action
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
School
Full name of responsible person
Dr. Hadi Morshedi
Street address
Department of Education, Malam Blvd, Alvand, Qazvin province, Iran
City
Alvand
Province
Qazvin
Postal code
3431878448
Phone
+98 28 3222 3334
Fax
Email
rataarya@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hadi Morshidi
Street address
Shahid Bahonar Boulevard, Qazvin, Iran, Qazvin University of Medical Scincese
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3335 9504
Email
rataarya@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
bahareh amini
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Shahid Bahonar Boulevard, Qazvin, Iran, Qazvin University of Medical Scincese
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3335 9504
Email
rataarya@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hadi Morshidi
Position
PhD in Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Qazvin University of Medical Scincese, Shahid Bahonar Boulevard, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3335 9504
Email
hmorshedi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hadi Morshidi
Position
PhD in Health Education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shahid Bahonar Boulevard, Qazvin, Iran, Qazvin University of Medical Scincese
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3335 9504
Email
hmorshedi@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available