Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03290118
Recruitment Status : Completed
First Posted : September 21, 2017
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Mary L'Abbe, University of Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Diet Modification Cardiovascular Diseases Nutrition Other: Nutrition Rating System - Traffic Light Other: Nutrition Rating System - Health Star Other: Nutrition Rating System - Warning Label Device: Smartphone application FoodFlip Device® Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2008 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Efficacy of Front-of-package Labelling Schemes: an Experimental Study
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : October 9, 2017
Actual Study Completion Date : October 9, 2017

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

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.

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: 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
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.

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.

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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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?

  2. 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?




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290118


Locations
Layout table for location information
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5S3E2
Sponsors and Collaborators
University of Toronto

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mary L'Abbe, Chair of the Department of Nutritional Sciences, University of Toronto
ClinicalTrials.gov Identifier: NCT03290118    
Other Study ID Numbers: 34393
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases