CClinicalTrials.gg
CompletedNCT03290118Updated Oct 4, 2018

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

An interventional study of Nutrition Rating System - Traffic Light and Nutrition Rating System - Health Star in Diet Modification, Cardiovascular Diseases and Nutrition, sponsored by University of Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-04.

Sponsored by University of Toronto · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
2,008
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diet Modification
  • Cardiovascular Diseases
  • Nutrition
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,008 participants (actual)

Study arms

  • 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 · Device: Smartphone application FoodFlip Device®

  • 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

    Other: Nutrition Rating System - Health Star · Device: Smartphone application FoodFlip Device®

  • 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

    Other: Nutrition Rating System - Warning Label · Device: Smartphone application FoodFlip Device®

  • 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.

Interventions

  • OtherNutrition 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.

  • OtherNutrition 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.

  • OtherNutrition 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.

  • DeviceSmartphone 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.

05

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

Secondary outcomes

  1. 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?

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

  2. 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?

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

06

Study locations

1 site
  • University of Toronto
    Toronto, Ontario M5S3E2, Canada
07

References and documents

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 33019950 ↗
  • Ahmed 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 ↗
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Registry details

Key details

Study ID
NCT03290118
Lead sponsor
University of Toronto
Responsible party
Mary L'Abbe (Chair of the Department of Nutritional Sciences, University of Toronto) — Principal investigator
First posted
Sep 21, 2017
Start date
Sep 20, 2017
Primary completion
Oct 9, 2017
Completion
Oct 9, 2017
Last update
Oct 4, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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