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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2008

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

September 20, 2017

Primary Completion (ACTUAL)

October 9, 2017

Study Completion (ACTUAL)

October 9, 2017

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 18, 2017

First Posted (ACTUAL)

September 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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