Diet ModificationNCT03290118
The Efficacy of Front-of-package Labelling Schemes: an Experimental Study
A study testing Nutrition Rating System - Traffic Light, Nutrition Rating System - Health Star and Nutrition Rating System - Warning Label in people with Diet Modification and Cardiovascular Diseases, run by University of Toronto at 1 site in Canada.
Trial summary
This is an online study that aims to test the effectiveness of Interpretative Nutrition Rating Systems (INRS) such as the Health Star Rating System (HSR or Star System), traffic light system and warning labels (high sodium, saturated fat and sugar) proposed by Health Canada. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Modification, Cardiovascular Diseases, Nutrition
- What is being tested?
- Nutrition Rating System - Traffic Light, Nutrition Rating System - Health Star and Nutrition Rating System - Warning Label
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,008 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2017to 9 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- speak English as a primary language
- reside in Canada excluding the Northern Territories
- are 18 years or over
- provide informed consent
- do at least some of the household grocery shopping
- own a smartphone (version iPhone 3 or later or Android)
- are able to complete the survey on a minimum screen size of 9.7 inches.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This is an online study that aims to test the effectiveness of Interpretative Nutrition Rating Systems (INRS) such as the Health Star Rating System (HSR or Star System), traffic light system and warning labels (high sodium, saturated fat and sugar) proposed by Health Canada. The study will incorporate the use of a Smartphone application (app), FoodFlip®, to help educate consumers on each INRS prior to their exposure on food packages.
- Conditions
- Diet Modification, Cardiovascular Diseases, Nutrition
- Being tested
- Nutrition Rating System - Traffic Light, Nutrition Rating System - Health Star, Nutrition Rating System - Warning Label, Smartphone application FoodFlip Device®
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Rating System - Traffic LightOther
Behavioural: Nutrition Rating Systems (shown on the online survey and the mobile app) provide consumers with an interpretation of the healthfulness of a food or beverage, by indicating the levels (low=green, moderate=amber, high=red) of sodium, saturated fat and sugar in a product based on modified Food Standards Australia New Zealand (FSANZ) criteria.
Nutrition Rating System - Health StarOther
Behavioural: Nutrition Rating Systems (shown on the online survey and the mobile app) provide consumers with an interpretation of the healthfulness of a food or beverage product by indicating the number of stars awarded to a product, from 0.5 to 5 stars, based on modified Food Standards Australia New Zealand (FSANZ) nutrient profiling criteria.
Nutrition Rating System - Warning LabelOther
Behavioural: Nutrition Rating Systems (shown on the online survey and the mobile app) provide consumers with an interpretation of the healthfulness of a food or beverage product by indicating with a warning label products that are "high" in sodium, saturated fat and sugar, based on a percent daily value (%DV) greater than 15% for individual products and 30% for combination dishes.
Smartphone application FoodFlip Device®Device
This is embedded within each condition to inform and educate consumers about the labelling condition/intervention to which they are randomized. All participants are assigned to an app task to view 20 products and see the 'rating' these products would get according to their condition.
| Study group | Role | What they receive |
|---|---|---|
| Traffic Light | Experimental | Participants in this group will be provided with a survey that shows the food and beverage packages with traffic light front of pack labels only.
Intervention is the Nutrition Rating System - Traffic Light Receives: Other: Nutrition Rating System - Traffic Light; Device: Smartphone application FoodFlip Device® |
| Star System | Experimental | Participants in this group will be provided with a survey that shows the food and beverage packages with health star rating front of pack labels only.
Intervention is the Nutrition Rating System - Health Star Rating Receives: Other: Nutrition Rating System - Health Star; Device: Smartphone application FoodFlip Device® |
| Warning Label | Experimental | Participants in this group will be provided with a survey that shows the food and beverage packages with warning front of pack labels only.
Intervention is the Nutrition Rating System - Warning Labels Receives: Other: Nutrition Rating System - Warning Label; Device: Smartphone application FoodFlip Device® |
| Control | No intervention | Participants in this group will be provided with a survey that shows the food and beverage packages without any front of pack labels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension task - ability to identify healthy products (survey measure)
The participant's ability to identify the most healthy product in a group of 5 products in a task rating 5 products with varying levels of 'healthiness' according to modified FSANZ criteria. Question wording: Please rank these products in terms of healthiness where 1 is the"most healthy" and 5 is the "least healthy" cereal
Measured: 1 day (assessed immediately after app task and while viewing products with labelling system applied
Comprehension task - ability to identify unhealthy products (survey measure)
The participant's ability to identify the least healthy product in a group of products in a group of 5 products in a task rating 5 products with varying levels of 'healthiness' according to modified FSANZ criteria. Question wording: Please rank these products in terms of healthiness where 1 is the"most healthy" and 5 is the "least healthy" cereal
Measured: 1 day (assessed immediately after app task and while viewing products with labelling system applied
Secondary outcomes (2)
Comprehension task - ability to identify the overall 'healthiness' of a product (survey measure - Likert scale)
The participant's ability to accurately rate a product as more or less healthy according to the type and amount of nutritional information on the product, using a 7 point Likert scale. Question wording: How healthy is this (product) for you?
Measured: 1 day (assessed immediately after app task and while viewing products with labelling system applied
Hypothetical purchasing of products (survey measure - Likert scale)
The participant's perceived likelihood of purchasing a product according to the type and amount of nutritional information on the product, using a 7 point Likert scale.
Question wording: Assume this product has a cost similar to other (product category). If you were shopping for (product), how likely would you be to purchase this one?
Measured: 1 day (assessed immediately after app task and while viewing products with labelling system applied
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start20 Sep 2017
- Primary completion9 Oct 2017
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary L'Abbe, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290118
- Sponsor's protocol ID
- 34393
- Status last verified
- Oct 2018
- First submitted
- 8 Sep 2017
- Last updated
- 4 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vanderlee L, Franco-Arellano B, Ahmed M, Oh A, Lou W, L'Abbe MR. The efficacy of 'high in' warning labels, health star and traffic light front-of-package labelling: an online randomised control trial. Public Health Nutr. 2021 Jan;24(1):62-74. doi: 10.1017/S1368980020003213. Epub 2020 Oct 6.
PubMed 33019950Ahmed M, Oh A, Vanderlee L, Franco-Arellano B, Schermel A, Lou W, L'Abbe MR. A randomized controlled trial examining consumers' perceptions and opinions on using different versions of a FoodFlip(c) smartphone application for delivery of nutrition information. Int J Behav Nutr Phys Act. 2020 Feb 12;17(1):22. doi: 10.1186/s12966-020-0923-1.
PubMed 32050996
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Front-of-package Labelling Schemes: an Experimental Study
- ClinicalTrials.gov ID
- NCT03290118
- Acronym / sponsor ID
- 34393
- Conditions
- Diet Modification, Cardiovascular Diseases, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,008 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an online study that aims to test the effectiveness of Interpretative Nutrition Rating Systems (INRS) such as the Health Star Rating System (HSR or Star System), traffic light system and warning labels (high sodium, saturated fat and sugar) proposed by Health Canada. The study will incorporate the use of a Smartphone application (app), FoodFlip®, to help educate consumers on each INRS prior to their exposure on food packages.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traffic Light | Experimental | Other: Nutrition Rating System - Traffic Light, Device: Smartphone application FoodFlip Device®Participants in this group will be provided with a survey that shows the food and beverage packages with traffic light front of pack labels only. Intervention is the Nutrition Rating System - Traffic Light |
| Star System | Experimental | Other: Nutrition Rating System - Health Star, Device: Smartphone application FoodFlip Device®Participants in this group will be provided with a survey that shows the food and beverage packages with health star rating front of pack labels only. Intervention is the Nutrition Rating System - Health Star Rating |
| Warning Label | Experimental | Other: Nutrition Rating System - Warning Label, Device: Smartphone application FoodFlip Device®Participants in this group will be provided with a survey that shows the food and beverage packages with warning front of pack labels only. Intervention is the Nutrition Rating System - Warning Labels |
| Control | No intervention | –Participants in this group will be provided with a survey that shows the food and beverage packages without any front of pack labels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- speak English as a primary language
- reside in Canada excluding the Northern Territories
- are 18 years or over
- provide informed consent
- do at least some of the household grocery shopping
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition Rating System - Traffic LightBehavioural: Nutrition Rating Systems (shown on the online survey and the mobile app) provide consumers with an interpretation of the healthfulness of a food or beverage, by indicating the levels (low=green, moderate=amber, high=red) of sodium, saturated fat and sugar in a product based on modified Food Standards Australia New Zealand (FSANZ) criteria. | Other | Traffic Light |
| Nutrition Rating System - Health StarBehavioural: Nutrition Rating Systems (shown on the online survey and the mobile app) provide consumers with an interpretation of the healthfulness of a food or beverage product by indicating the number of stars awarded to a product, from 0.5 to 5 stars, based on modified Food Standards Australia New Zealand (FSANZ) nutrient profiling criteria. | Other | Star System |
| Nutrition Rating System - Warning LabelBehavioural: Nutrition Rating Systems (shown on the online survey and the mobile app) provide consumers with an interpretation of the healthfulness of a food or beverage product by indicating with a warning label products that are "high" in sodium, saturated fat and sugar, based on a percent daily value (%DV) greater than 15% for individual products and 30% for combination dishes. | Other | Warning Label |
| Smartphone application FoodFlip Device®This is embedded within each condition to inform and educate consumers about the labelling condition/intervention to which they are randomized. All participants are assigned to an app task to view 20 products and see the 'rating' these products would get according to their condition. | Device | Star System, Traffic Light, Warning Label |
Primary outcome
Comprehension task - ability to identify healthy products (survey measure)
Time frame: 1 day (assessed immediately after app task and while viewing products with labelling system applied
The participant's ability to identify the most healthy product in a group of 5 products in a task rating 5 products with varying levels of 'healthiness' according to modified FSANZ criteria. Question wording: Please rank these products in terms of healthiness where 1 is the"most healthy" and 5 is the "least healthy" cereal
Comprehension task - ability to identify unhealthy products (survey measure)
Time frame: 1 day (assessed immediately after app task and while viewing products with labelling system applied
The participant's ability to identify the least healthy product in a group of products in a group of 5 products in a task rating 5 products with varying levels of 'healthiness' according to modified FSANZ criteria. Question wording: Please rank these products in terms of healthiness where 1 is the"most healthy" and 5 is the "least healthy" cereal
2 secondary outcomes
Comprehension task - ability to identify the overall 'healthiness' of a product (survey measure - Likert scale)
Time frame: 1 day (assessed immediately after app task and while viewing products with labelling system applied
Hypothetical purchasing of products (survey measure - Likert scale)
Time frame: 1 day (assessed immediately after app task and while viewing products with labelling system applied
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Derived from this study: PubMed 33019950Vanderlee L, Franco-Arellano B, Ahmed M, Oh A, Lou W, L'Abbe MR. The efficacy of 'high in' warning labels, health star and traffic light front-of-package labelling: an online randomised control trial. Public Health Nutr. 2021 Jan;24(1):62-74. doi: 10.1017/S1368980020003213. Epub 2020 Oct 6.
- Derived from this study: PubMed 32050996Ahmed M, Oh A, Vanderlee L, Franco-Arellano B, Schermel A, Lou W, L'Abbe MR. A randomized controlled trial examining consumers' perceptions and opinions on using different versions of a FoodFlip(c) smartphone application for delivery of nutrition information. Int J Behav Nutr Phys Act. 2020 Feb 12;17(1):22. doi: 10.1186/s12966-020-0923-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Rating System - Traffic Light, Nutrition Rating System - Health Star and Nutrition Rating System - Warning Label in people with Diet Modification and Cardiovascular Diseases, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension task - ability to identify healthy products (survey measure) (time frame: 1 day (assessed immediately after app task and while viewing products with labelling system applied). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03290118, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.