The effect of physical activity labeling which indicates the amount of physical activity needed to burn energy of chosen food, and traffic light labeling on food choice
The purpose of this study is to compare the existing food labels (traffic light label) with a new label which will be designed by the researchers.
Design
This study will be conducted in qualitative and quantitative phases.
Step 1: Assessment of current status of labeling
In this section, the strengths and weaknesses of existing labels will be explained.
Step 2: designing a new label and testing interventions
Number: 500 Mother
Mothers randomly will enter into 5 groups. First group: without nutrition label, second group: traffic light label (without informing mothers) - Third group traffic light label (by informing mothers via brochures) - Group 4 physical activity labels (without informing mothers) - Group 5 physical activity labels (by Informing mothers via brochures). The brochures will be sent with an invitation.
Settings and conduct
Intervention in schools will take place. Mothers are not aware of the main purpose of the project, and the investigator is unaware of the division of mothers in each groups.
Participants/Inclusion and exclusion criteria
Include: Participants are mothers who can read and write. They also want to participate in the study. Exclude: Pregnant, lactating or diseases such as diabetes, allergies, etc. and diets.
Intervention groups
To assess the impact of new label, the school community will be used. They will be randomly selected from elementary schools from both sex groups.
Main outcome variables
Total calories of selected products in each groups are considered as the final result.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181002041201N1
Registration date:2018-10-25, 1397/08/03
Registration timing:registered_while_recruiting
Last update:2018-10-25, 1397/08/03
Update count:0
Registration date
2018-10-25, 1397/08/03
Registrant information
Name
Shirin Seyedhamzeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 4837
Email address
shirinseyedhamzeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-13, 1397/07/21
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of physical activity labeling which indicates the amount of physical activity needed to burn energy of chosen food, and traffic light labeling on food choice
Public title
The effect of physical activity labeling and traffic light labeling on food choice
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Participants are mothers who can read and write and want to participate in the study.
Exclusion criteria:
Those individuals who are pregnant, lactating, or have diseases such as diabetes, allergies, etc., and those with diets will be excluded.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
500
Randomization (investigator's opinion)
Randomized
Randomization description
To evaluate the effect of physical activity labeling, schools from Tehran will be assigned. Block randomization will be considered. Tehran will be divided into five regions: north, south, east, west and center. two schools from each region will be randomly selected. Preschool and elementary schools (girls or boys) will be included. Fifty mothers will be randomly enrolled from each school, Then selected mothers will be divided into five groups. A total of 500 mothers will be included.
Blinding (investigator's opinion)
Double blinded
Blinding description
Mothers will be not aware of the aim of the study, so their food choices will be not affected.
The divisions will be done by an expert and the researcher will not aware of it.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshavarz boulevard, Ghods St
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-01-08, 1396/10/18
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4160
Health conditions studied
1
Description of health condition studied
prevention of non-communicable diseases
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The total calories of selected products in each groups are considered as the final result.
Timepoint
Immediately after food choice
Method of measurement
observation and record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group number1: physical activity labeling: After designing physical activity label in the first step, it will be produced by a printing office and will be fixed on products (dairy products- beverages- cakes and biscuits). It will be asked from mothers to assume that they are a supermarket and choose from the products that are available. This label will compare with the traffic light label which is currently in use. Mothers will only encounter this label once. one hundred mothers will participate in this group.
Category
Prevention
2
Description
Intervention group number 2: physical activity labeling via brochure: Physical activity label with brochure: In this group, an educational brochure for choosing healthy food will be given to one hundred mothers, so the effect of education on choice is taken into account. The results of this group will be compared with the traffic light label group via brochure.
Category
Prevention
3
Description
Intervention group number 3: traffic light labeling: In this group, 100 mothers will be included and they will select once from the products with a traffic light labels.
Category
Prevention
4
Description
Intervention group number 4: traffic light labeling via brochure: An educational brochure with healthy food choice information will be provided for the 100 mothers in this group to determine its impact on food choice.
Category
Prevention
5
Description
Control group: without nutrition labeling: 100 mothers will enter to this group, and will make their choices among products that do not have any nutritional labels so we can determine the impact of nutritional labels.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Elementary schools from Tehran
Full name of responsible person
Ahmadreza Dorosti Motlagh
Street address
No 44, Naderi St, Hojjat doost Alley, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416643931
Phone
+98 21 8895 5975
Email
dorostim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shokoufeh Nikfar
Street address
Ghods St, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
Nikfar_sh@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shirin Seyedhamzeh
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 44, Hojjat-dost Alley, Naderi Street, Keshavarz Boulevard