The Efficacy of Front-of-package Labelling Schemes: an Experimental Study

October 3, 2018 updated by: Mary L'Abbe, University of Toronto
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2008

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S3E2
        • University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Traffic Light

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
Other: Nutrition Rating System - Traffic Light
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.
Device: 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.
EXPERIMENTAL: Star System

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
Device: 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.
Other: Nutrition Rating System - Health Star
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.
EXPERIMENTAL: Warning Label

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
Device: 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.
Other: Nutrition Rating System - Warning Label
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.
NO_INTERVENTION: Control
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 day (assessed immediately after app task and while viewing products with labelling system applied
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
1 day (assessed immediately after app task and while viewing products with labelling system applied

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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?
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

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?
1 day (assessed immediately after app task and while viewing products with labelling system applied

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 34393

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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