<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03290118</url>
  </required_header>
  <id_info>
    <org_study_id>34393</org_study_id>
    <nct_id>NCT03290118</nct_id>
  </id_info>
  <brief_title>The Efficacy of Front-of-package Labelling Schemes: an Experimental Study</brief_title>
  <official_title>The Efficacy of Front-of-package Labelling Schemes: an Experimental Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an online study that aims to test the effectiveness of Interpretative Nutrition&#xD;
      Rating Systems (INRS) such as the Health Star Rating System (HSR or Star System), traffic&#xD;
      light system and warning labels (high sodium, saturated fat and sugar) proposed by Health&#xD;
      Canada. The study will incorporate the use of a Smartphone application (app), FoodFlip®, to&#xD;
      help educate consumers on each INRS prior to their exposure on food packages.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">October 9, 2017</completion_date>
  <primary_completion_date type="Actual">October 9, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comprehension task - ability to identify healthy products (survey measure)</measure>
    <time_frame>1 day (assessed immediately after app task and while viewing products with labelling system applied</time_frame>
    <description>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&quot;most healthy&quot; and 5 is the &quot;least healthy&quot; cereal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comprehension task - ability to identify unhealthy products (survey measure)</measure>
    <time_frame>1 day (assessed immediately after app task and while viewing products with labelling system applied</time_frame>
    <description>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&quot;most healthy&quot; and 5 is the &quot;least healthy&quot; cereal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comprehension task - ability to identify the overall 'healthiness' of a product (survey measure - Likert scale)</measure>
    <time_frame>1 day (assessed immediately after app task and while viewing products with labelling system applied</time_frame>
    <description>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?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypothetical purchasing of products (survey measure - Likert scale)</measure>
    <time_frame>1 day (assessed immediately after app task and while viewing products with labelling system applied</time_frame>
    <description>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.&#xD;
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?</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">2008</enrollment>
  <condition>Diet Modification</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Nutrition</condition>
  <arm_group>
    <arm_group_label>Traffic Light</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
Intervention is the Nutrition Rating System - Traffic Light</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Star System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
Intervention is the Nutrition Rating System - Health Star Rating</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warning Label</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will be provided with a survey that shows the food and beverage packages with warning front of pack labels only.&#xD;
Intervention is the Nutrition Rating System - Warning Labels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will be provided with a survey that shows the food and beverage packages without any front of pack labels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition Rating System - Traffic Light</intervention_name>
    <description>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.</description>
    <arm_group_label>Traffic Light</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition Rating System - Health Star</intervention_name>
    <description>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.</description>
    <arm_group_label>Star System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition Rating System - Warning Label</intervention_name>
    <description>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 &quot;high&quot; in sodium, saturated fat and sugar, based on a percent daily value (%DV) greater than 15% for individual products and 30% for combination dishes.</description>
    <arm_group_label>Warning Label</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Smartphone application FoodFlip Device®</intervention_name>
    <description>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.</description>
    <arm_group_label>Star System</arm_group_label>
    <arm_group_label>Traffic Light</arm_group_label>
    <arm_group_label>Warning Label</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  speak English as a primary language&#xD;
&#xD;
          -  reside in Canada excluding the Northern Territories&#xD;
&#xD;
          -  are 18 years or over&#xD;
&#xD;
          -  provide informed consent&#xD;
&#xD;
          -  do at least some of the household grocery shopping&#xD;
&#xD;
          -  own a smartphone (version iPhone 3 or later or Android)&#xD;
&#xD;
          -  are able to complete the survey on a minimum screen size of 9.7 inches.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S3E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>October 3, 2018</last_update_submitted>
  <last_update_submitted_qc>October 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Mary L'Abbe</investigator_full_name>
    <investigator_title>Chair of the Department of Nutritional Sciences</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03290118
org study id: 34393
nct id: NCT03290118
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
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
description: 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
measure: 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
description: 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
measure: 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
description: 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?
measure: 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
description: 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?
arm group label: Traffic Light
arm group type: Experimental
description: 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
arm group label: Star System
arm group type: Experimental
description: 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
arm group label: Warning Label
arm group type: Experimental
description: 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
arm group label: Control
arm group type: No Intervention
description: Participants in this group will be provided with a survey that shows the food and beverage packages without any front of pack labels.
intervention type: Other
intervention name: Nutrition Rating System - Traffic Light
description: 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.
arm group label: Traffic Light
intervention type: Other
intervention name: Nutrition Rating System - Health Star
description: 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.
arm group label: Star System
intervention type: Other
intervention name: Nutrition Rating System - Warning Label
description: 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.
arm group label: Warning Label
intervention type: Device
intervention name: Smartphone application FoodFlip Device®
description: 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.
arm group label: Star System
arm group label: Traffic Light
arm group label: Warning Label
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Mary L'Abbe
investigator title: Chair of the Department of Nutritional Sciences
mesh term: Cardiovascular Diseases