xml: <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/NCT06033911</url>
    </required_header>
    <id_info>
      <org_study_id>508519</org_study_id>
      <secondary_id>CIHR UD1-170157</secondary_id>
      <nct_id>NCT06033911</nct_id>
    </id_info>
    <brief_title>Using FoodFlip© to Improve Food Choices Among Post-secondary Students</brief_title>
    <official_title>A Randomized Controlled Trial Using FoodFlip©, a Mobile Phone App, to Promote Healthier Diets and Food Choices Among Post-Secondary Students</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>
        Canada passed mandatory front-of-package labelling (FOPL) regulations where pre-packaged food&#xD;
        and beverage products that are high in sugar, saturated fat, and/or sodium are required to&#xD;
        display a 'high-in' front-of-pack nutrition symbol (NS). FOPL is an effective tool to inform&#xD;
        consumers about products that can harm health and help guide their purchasing decisions.&#xD;
        However, as the regulations are limited to the pre-packaged food supply and do not apply to&#xD;
        restaurants and other food services, little is known about the potential impact of the NS in&#xD;
        such settings. Therefore, the objective of the present study is to investigate the impact of&#xD;
        the Canadian FOPL (i.e. the 'high-in' NS) as delivered through a mobile health (mHealth) app&#xD;
        in a setting currently not subject to regulations. The study will take place on a&#xD;
        post-secondary campus (University of Toronto) hosting students, a population vulnerable to&#xD;
        poor dietary choices, nutritional knowledge, and associated weight gain. A 2-week long,&#xD;
        randomized controlled trial with a 3-parallel arm study design will be conducted to explore&#xD;
        the effect of the 'high-in' NS on students' purchasing behaviours and nutritional knowledge.&#xD;
        Eligible participants will be randomly allocated into one of 3 intervention groups: no App&#xD;
        control; App control with no NS; App with NS. Questionnaires will be used to assess&#xD;
        nutritional knowledge, and receipts will be used to analyze purchasing behaviour.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Poor diets increase the risk of non-communicable diseases (NCDs), one of the major causes of&#xD;
        disability and premature mortality in Canada. To help improve the diets of Canadians, Health&#xD;
        Canada recently promulgated front-of-pack labelling (FOPL) regulations, which mandate&#xD;
        pre-packaged foods and beverages meeting and/or exceeding the thresholds for nutrients of&#xD;
        public health concern (i.e., sugars, saturated fat, and/or sodium) to display a 'high-in'&#xD;
        front-of-pack nutrition symbol (NS). Moreover, previous studies have shown that FOPL can&#xD;
        improve purchasing behaviours of consumers by decreasing purchases of nutrients of public&#xD;
        health concern and/or foods carrying 'less healthy' FOPL and increase the nutritional&#xD;
        knowledge of consumers. However, the FOPL regulations do not address restaurant foods, which&#xD;
        are significant caloric contributors to the Canadian diet and are often high in nutrients of&#xD;
        public health concern. Further, FOPL regulations do not address foods sold in other&#xD;
        institutional settings, including schools, long-term care homes, and daycares. This policy&#xD;
        gap may adversely affect the young adult population - a group notably vulnerable to poor&#xD;
        diets and associated weight gain and poor nutritional knowledge. Emerging evidence suggests&#xD;
        that FOPL can be an effective tool to communicate nutrition information to promote healthier&#xD;
        food choices in food service settings; however, limited data exist on the effectiveness of&#xD;
        FOPL on menu items available on post-secondary campuses to influence students' food&#xD;
        purchasing behaviours on campus and to improve their nutritional knowledge. Furthermore,&#xD;
        nutrition mobile health (mHealth) apps have been shown to have the potential to support&#xD;
        behavioural change, improve nutrition knowledge, and develop skills to promote healthy eating&#xD;
        behaviours through quick information-sharing capacity, customizable tracking abilities, and&#xD;
        interactive components. The L'Abbe Lab has developed a mobile application, FoodFlip©, that&#xD;
        provides nutrition information at the point of purchase to influence the decision-making&#xD;
        process with high usability and functionality in grocery shopping settings. However, the&#xD;
        application of FoodFlip© on purchasing behaviours in post-secondary campus settings is&#xD;
        unknown. Therefore, the primary objective of the study is to investigate the effect of the&#xD;
        Canadian FOPL (i.e., the 'high-in' nutrition symbol) on purchasing behaviours and nutritional&#xD;
        knowledge of post-secondary students on campus, using the FoodFlip© App.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>
      <intervention_model_description>2-week long, single-blinded randomized controlled trial with a 3-parallel arm.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants will be allocated into one of 3 groups: (i) no App control; (ii) App without 'high-in' nutrition symbol; (iii) App with Canada's 'high-in' nutrition symbol</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Purchasing Behaviors</measure>
      <time_frame>2 weeks</time_frame>
      <description>Purchasing behaviours will be assessed using receipts and/or records provided by participants over the 2-week study period. Nutritional quality of purchased menu items will be determined using a nutrient profiling model based on the thresholds for Canada's FOPL regulations. Menu items will be assigned a &quot;Menu item score&quot; on a scale of 0 (minimum) to 3 (maximum), with 0 indicating no 'high-in' nutrients and 3 being 'high-in' all 3 nutrients-of-concern. Scores of each menu item purchased will be summed and divided by the total number of purchases to derive the final score for each participant; higher scores mean lower nutritional quality (i.e. worse outcome) and lower scores mean higher nutritional quality (i.e. better outcome). The final scores will then be compared between intervention groups, and change in nutritional quality will be compared within intervention groups at 2 time points: early intervention (end of Week 1) and late intervention (end of study period).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Nutritional Knowledge</measure>
      <time_frame>2 weeks</time_frame>
      <description>Nutritional knowledge will be assessed using an online questionnaire developed and validated by the L'Abbe Lab. Questionnaire will be completed by participants at 1) baseline and 2) end-of-study. This short (10-15 min) survey of 30 short questions will include questions assessing health literacy and nutritional knowledge that have been adapted from validated questionnaires. Correct answers will be coded as &quot;1&quot; while incorrect answers will be coded as &quot;0&quot;, with a maximum of 30 points. Higher scores indicate higher nutritional knowledge (i.e. better outcome), and lower scores indicate lower nutritional knowledge (i.e. worse outcome). Between intervention groups differences in nutritional knowledge will be assessed using ANOVA, while changes in nutritional knowledge from baseline to end-of-study will be compared within intervention groups using Mann-Whitney U-tests.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Healthy Diet</condition>
    <arm_group>
      <arm_group_label>No App</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention. Participants will be given access to a web-based submission portal.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FoodFlip© App with no nutrition symbol</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Intervention control: participants will have access to food information in the shape of a Nutrition Facts table through FoodFlip©. Participants will have access to a submission portal linked to their study ID through the app.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FoodFlip© App with 'high-in' nutrition symbol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intervention: Participants will have access to food information through FoodFlip© with Health Canada's 'high-in' nutrition symbol. ©. Participants will have access to a submission portal linked to their study ID through the app.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>FoodFlip© App with no nutrition symbol</intervention_name>
      <description>Intervention control: participants will have access to food information such as calories or the Nutrition Facts table through FoodFlip©</description>
      <arm_group_label>FoodFlip© App with no nutrition symbol</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>FoodFlip© App with 'high-in' nutrition symbol</intervention_name>
      <description>Intervention: Participants will have access to food information through FoodFlip© with Canada's 'high-in' NS</description>
      <arm_group_label>FoodFlip© App with 'high-in' nutrition symbol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18 years of age&#xD;
  &#xD;
            -  enrolled at UofT&#xD;
  &#xD;
            -  have regular access to either iPhone or Android&#xD;
  &#xD;
            -  purchases at least one meal a day on campus&#xD;
  &#xD;
            -  able to speak and read English&#xD;
  &#xD;
            -  not currently pregnant or in lactation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 and &gt;30 years of age&#xD;
  &#xD;
            -  not enrolled at UofT&#xD;
  &#xD;
            -  does not have access to a smartphone&#xD;
  &#xD;
            -  does not purchase at least one meal a day on campus&#xD;
  &#xD;
            -  unable to speak and read English&#xD;
  &#xD;
            -  currently pregnant or in lactation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mary R L'Abbe, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Toronto</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hayun Jeong, HBSc</last_name>
      <role>Study Director</role>
      <affiliation>University of Toronto</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mary R L'Abbe, PhD</last_name>
      <phone>4166051902</phone>
      <email>mary.labbe@utoronto.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Nutritional Sciences, University of Toronto</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5S 1A8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Department of Nutritional Sciences</last_name>
        <phone>4169782422</phone>
        <email>dns.admin@utoronto.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>World Health Organization, Chronic diseases and their common risk factors. 2005 [cited 2021 Sept 1]; Available from: https://www.who.int/chp/ chronic_disease_report/media/Factsheet1.pdf.</citation>
    </reference>
    <reference>
      <citation>World Health Organization, Noncommunicable diseases country profiles 2018. 2018 [cited 2021 Sept 1]; Available from: https://www.who.int/nmh/ publications/ncd-profiles-2018/en/.</citation>
    </reference>
    <reference>
      <citation>Health Canada. Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) [Internet]. Canada Gazette, Part II. 2022. Available from: https://canadagazette.gc.ca/rp-pr/p2/2022/2022-07-20/html/sor-dors168-eng.htmlHealth.</citation>
    </reference>
    <reference>
      <citation>Vergeer L, Vanderlee L, Ahmed M, Franco-Arellano B, Mulligan C, Dickinson K, L'Abbe MR. A comparison of the nutritional quality of products offered by the top packaged food and beverage companies in Canada. BMC Public Health. 2020 May 11;20(1):650. doi: 10.1186/s12889-020-08828-w.</citation>
      <PMID>32393206</PMID>
    </reference>
    <reference>
      <citation>Ang FJL, Agrawal S, Finkelstein EA. Pilot randomized controlled trial testing the influence of front-of-pack sugar warning labels on food demand. BMC Public Health. 2019 Feb 7;19(1):164. doi: 10.1186/s12889-019-6496-8.</citation>
      <PMID>30732609</PMID>
    </reference>
    <reference>
      <citation>Neal B, Crino M, Dunford E, Gao A, Greenland R, Li N, Ngai J, Ni Mhurchu C, Pettigrew S, Sacks G, Webster J, Wu JH. Effects of Different Types of Front-of-Pack Labelling Information on the Healthiness of Food Purchases-A Randomised Controlled Trial. Nutrients. 2017 Nov 24;9(12):1284. doi: 10.3390/nu9121284.</citation>
      <PMID>29186803</PMID>
    </reference>
    <reference>
      <citation>Taillie LS, Reyes M, Colchero MA, Popkin B, Corvalan C. An evaluation of Chile's Law of Food Labeling and Advertising on sugar-sweetened beverage purchases from 2015 to 2017: A before-and-after study. PLoS Med. 2020 Feb 11;17(2):e1003015. doi: 10.1371/journal.pmed.1003015. eCollection 2020 Feb.</citation>
      <PMID>32045424</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33019950</PMID>
    </reference>
    <reference>
      <citation>Statistics Canada Eating out - How often and why [Stats in brief: 11-627-M2019003], Statistics Canada: Ottawa, Ontario. 2019.</citation>
    </reference>
    <reference>
      <citation>Moubarac, J.C., Ultra-processed foods in Canada: consumption, impact on diet quality and policy implications. University of Montreal: Montreal. 2017.</citation>
    </reference>
    <reference>
      <citation>Yang Y, Weippert M, Ahmed M, L'Abbe MR. Cross-Sectional Nutritional Information and Quality of Canadian Chain Restaurant Menu Items in 2020. Am J Prev Med. 2023 Jan;64(1):42-50. doi: 10.1016/j.amepre.2022.07.015. Epub 2022 Sep 22.</citation>
      <PMID>36155709</PMID>
    </reference>
    <reference>
      <citation>Murphy SA, Weippert MV, Dickinson KM, Scourboutakos MJ, L'Abbe MR. Cross-Sectional Analysis of Calories and Nutrients of Concern in Canadian Chain Restaurant Menu Items in 2016. Am J Prev Med. 2020 Oct;59(4):e149-e159. doi: 10.1016/j.amepre.2020.05.005. Epub 2020 Aug 20.</citation>
      <PMID>32828587</PMID>
    </reference>
    <reference>
      <citation>Vella-Zarb RA, Elgar FJ. The 'freshman 5': a meta-analysis of weight gain in the freshman year of college. J Am Coll Health. 2009 Sep-Oct;58(2):161-6. doi: 10.1080/07448480903221392.</citation>
      <PMID>19892653</PMID>
    </reference>
    <reference>
      <citation>Levitsky DA, Halbmaier CA, Mrdjenovic G. The freshman weight gain: a model for the study of the epidemic of obesity. Int J Obes Relat Metab Disord. 2004 Nov;28(11):1435-42. doi: 10.1038/sj.ijo.0802776.</citation>
      <PMID>15365585</PMID>
    </reference>
    <reference>
      <citation>Matthews JI, Doerr L, Dworatzek PDN. University Students Intend to Eat Better but Lack Coping Self-Efficacy and Knowledge of Dietary Recommendations. J Nutr Educ Behav. 2016 Jan;48(1):12-19.e1. doi: 10.1016/j.jneb.2015.08.005. Epub 2015 Sep 28.</citation>
      <PMID>26424531</PMID>
    </reference>
    <reference>
      <citation>Block JP, Roberto CA. Potential benefits of calorie labeling in restaurants. JAMA. 2014 Sep 3;312(9):887-8. doi: 10.1001/jama.2014.9239. No abstract available.</citation>
      <PMID>25077460</PMID>
    </reference>
    <reference>
      <citation>West JH, Belvedere LM, Andreasen R, Frandsen C, Hall PC, Crookston BT. Controlling Your &quot;App&quot;etite: How Diet and Nutrition-Related Mobile Apps Lead to Behavior Change. JMIR Mhealth Uhealth. 2017 Jul 10;5(7):e95. doi: 10.2196/mhealth.7410.</citation>
      <PMID>28694241</PMID>
    </reference>
    <reference>
      <citation>McCarroll R, Eyles H, Ni Mhurchu C. Effectiveness of mobile health (mHealth) interventions for promoting healthy eating in adults: A systematic review. Prev Med. 2017 Dec;105:156-168. doi: 10.1016/j.ypmed.2017.08.022. Epub 2017 Sep 4.</citation>
      <PMID>28882743</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32050996</PMID>
    </reference>
    <reference>
      <citation>Pan American Health Organization. Front-of-package labeling [Internet]. Available from: https://www.paho.org/en/topics/front-package-labeling</citation>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>Professor Emeritus, CM, PhD</investigator_title>
    </responsible_party>
    <keyword>front-of-package labeling</keyword>
    <keyword>post-secondary foods</keyword>
    <keyword>university foods</keyword>
    <keyword>universities</keyword>
    <keyword>mobile applications</keyword>
    <keyword>mobile health</keyword>
    <keyword>smartphone</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm Metastasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033911
  org study id: 508519
  secondary id: CIHR UD1-170157
  nct id: NCT06033911
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Canada passed mandatory front-of-package labelling (FOPL) regulations where pre-packaged food
        and beverage products that are high in sugar, saturated fat, and/or sodium are required to
        display a 'high-in' front-of-pack nutrition symbol (NS). FOPL is an effective tool to inform
        consumers about products that can harm health and help guide their purchasing decisions.
        However, as the regulations are limited to the pre-packaged food supply and do not apply to
        restaurants and other food services, little is known about the potential impact of the NS in
        such settings. Therefore, the objective of the present study is to investigate the impact of
        the Canadian FOPL (i.e. the 'high-in' NS) as delivered through a mobile health (mHealth) app
        in a setting currently not subject to regulations. The study will take place on a
        post-secondary campus (University of Toronto) hosting students, a population vulnerable to
        poor dietary choices, nutritional knowledge, and associated weight gain. A 2-week long,
        randomized controlled trial with a 3-parallel arm study design will be conducted to explore
        the effect of the 'high-in' NS on students' purchasing behaviours and nutritional knowledge.
        Eligible participants will be randomly allocated into one of 3 intervention groups: no App
        control; App control with no NS; App with NS. Questionnaires will be used to assess
        nutritional knowledge, and receipts will be used to analyze purchasing behaviour.
  Poor diets increase the risk of non-communicable diseases (NCDs), one of the major causes of
        disability and premature mortality in Canada. To help improve the diets of Canadians, Health
        Canada recently promulgated front-of-pack labelling (FOPL) regulations, which mandate
        pre-packaged foods and beverages meeting and/or exceeding the thresholds for nutrients of
        public health concern (i.e., sugars, saturated fat, and/or sodium) to display a 'high-in'
        front-of-pack nutrition symbol (NS). Moreover, previous studies have shown that FOPL can
        improve purchasing behaviours of consumers by decreasing purchases of nutrients of public
        health concern and/or foods carrying 'less healthy' FOPL and increase the nutritional
        knowledge of consumers. However, the FOPL regulations do not address restaurant foods, which
        are significant caloric contributors to the Canadian diet and are often high in nutrients of
        public health concern. Further, FOPL regulations do not address foods sold in other
        institutional settings, including schools, long-term care homes, and daycares. This policy
        gap may adversely affect the young adult population - a group notably vulnerable to poor
        diets and associated weight gain and poor nutritional knowledge. Emerging evidence suggests
        that FOPL can be an effective tool to communicate nutrition information to promote healthier
        food choices in food service settings; however, limited data exist on the effectiveness of
        FOPL on menu items available on post-secondary campuses to influence students' food
        purchasing behaviours on campus and to improve their nutritional knowledge. Furthermore,
        nutrition mobile health (mHealth) apps have been shown to have the potential to support
        behavioural change, improve nutrition knowledge, and develop skills to promote healthy eating
        behaviours through quick information-sharing capacity, customizable tracking abilities, and
        interactive components. The L'Abbe Lab has developed a mobile application, FoodFlip©, that
        provides nutrition information at the point of purchase to influence the decision-making
        process with high usability and functionality in grocery shopping settings. However, the
        application of FoodFlip© on purchasing behaviours in post-secondary campus settings is
        unknown. Therefore, the primary objective of the study is to investigate the effect of the
        Canadian FOPL (i.e., the 'high-in' nutrition symbol) on purchasing behaviours and nutritional
        knowledge of post-secondary students on campus, using the FoodFlip© App.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 2-week long, single-blinded randomized controlled trial with a 3-parallel arm.
  primary purpose: Other
  masking: Single (Participant)
  masking description: Participants will be allocated into one of 3 groups: (i) no App control; (ii) App without 'high-in' nutrition symbol; (iii) App with Canada's 'high-in' nutrition symbol
  measure: Purchasing Behaviors
  time frame: 2 weeks
  description: Purchasing behaviours will be assessed using receipts and/or records provided by participants over the 2-week study period. Nutritional quality of purchased menu items will be determined using a nutrient profiling model based on the thresholds for Canada's FOPL regulations. Menu items will be assigned a "Menu item score" on a scale of 0 (minimum) to 3 (maximum), with 0 indicating no 'high-in' nutrients and 3 being 'high-in' all 3 nutrients-of-concern. Scores of each menu item purchased will be summed and divided by the total number of purchases to derive the final score for each participant; higher scores mean lower nutritional quality (i.e. worse outcome) and lower scores mean higher nutritional quality (i.e. better outcome). The final scores will then be compared between intervention groups, and change in nutritional quality will be compared within intervention groups at 2 time points: early intervention (end of Week 1) and late intervention (end of study period).
  measure: Nutritional Knowledge
  time frame: 2 weeks
  description: Nutritional knowledge will be assessed using an online questionnaire developed and validated by the L'Abbe Lab. Questionnaire will be completed by participants at 1) baseline and 2) end-of-study. This short (10-15 min) survey of 30 short questions will include questions assessing health literacy and nutritional knowledge that have been adapted from validated questionnaires. Correct answers will be coded as "1" while incorrect answers will be coded as "0", with a maximum of 30 points. Higher scores indicate higher nutritional knowledge (i.e. better outcome), and lower scores indicate lower nutritional knowledge (i.e. worse outcome). Between intervention groups differences in nutritional knowledge will be assessed using ANOVA, while changes in nutritional knowledge from baseline to end-of-study will be compared within intervention groups using Mann-Whitney U-tests.
  arm group label: No App
  arm group type: No Intervention
  description: No intervention. Participants will be given access to a web-based submission portal.
  arm group label: FoodFlip© App with no nutrition symbol
  arm group type: Placebo Comparator
  description: Intervention control: participants will have access to food information in the shape of a Nutrition Facts table through FoodFlip©. Participants will have access to a submission portal linked to their study ID through the app.
  arm group label: FoodFlip© App with 'high-in' nutrition symbol
  arm group type: Active Comparator
  description: Intervention: Participants will have access to food information through FoodFlip© with Health Canada's 'high-in' nutrition symbol. ©. Participants will have access to a submission portal linked to their study ID through the app.
  intervention type: Device
  intervention name: FoodFlip© App with no nutrition symbol
  description: Intervention control: participants will have access to food information such as calories or the Nutrition Facts table through FoodFlip©
  arm group label: FoodFlip© App with no nutrition symbol
  intervention type: Device
  intervention name: FoodFlip© App with 'high-in' nutrition symbol
  description: Intervention: Participants will have access to food information through FoodFlip© with Canada's 'high-in' NS
  arm group label: FoodFlip© App with 'high-in' nutrition symbol
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mary R L'Abbe, PhD
  role: Principal Investigator
  affiliation: University of Toronto
  last name: Hayun Jeong, HBSc
  role: Study Director
  affiliation: University of Toronto
  last name: Mary R L'Abbe, PhD
  phone: 4166051902
  email: mary.labbe@utoronto.ca
  facility: 
  contact: 
  country: Canada
  citation: World Health Organization, Chronic diseases and their common risk factors. 2005 [cited 2021 Sept 1]; Available from: https://www.who.int/chp/ chronic_disease_report/media/Factsheet1.pdf.
  citation: World Health Organization, Noncommunicable diseases country profiles 2018. 2018 [cited 2021 Sept 1]; Available from: https://www.who.int/nmh/ publications/ncd-profiles-2018/en/.
  citation: Health Canada. Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) [Internet]. Canada Gazette, Part II. 2022. Available from: https://canadagazette.gc.ca/rp-pr/p2/2022/2022-07-20/html/sor-dors168-eng.htmlHealth.
  citation: Vergeer L, Vanderlee L, Ahmed M, Franco-Arellano B, Mulligan C, Dickinson K, L'Abbe MR. A comparison of the nutritional quality of products offered by the top packaged food and beverage companies in Canada. BMC Public Health. 2020 May 11;20(1):650. doi: 10.1186/s12889-020-08828-w.
  PMID: 32393206
  citation: Ang FJL, Agrawal S, Finkelstein EA. Pilot randomized controlled trial testing the influence of front-of-pack sugar warning labels on food demand. BMC Public Health. 2019 Feb 7;19(1):164. doi: 10.1186/s12889-019-6496-8.
  PMID: 30732609
  citation: Neal B, Crino M, Dunford E, Gao A, Greenland R, Li N, Ngai J, Ni Mhurchu C, Pettigrew S, Sacks G, Webster J, Wu JH. Effects of Different Types of Front-of-Pack Labelling Information on the Healthiness of Food Purchases-A Randomised Controlled Trial. Nutrients. 2017 Nov 24;9(12):1284. doi: 10.3390/nu9121284.
  PMID: 29186803
  citation: Taillie LS, Reyes M, Colchero MA, Popkin B, Corvalan C. An evaluation of Chile's Law of Food Labeling and Advertising on sugar-sweetened beverage purchases from 2015 to 2017: A before-and-after study. PLoS Med. 2020 Feb 11;17(2):e1003015. doi: 10.1371/journal.pmed.1003015. eCollection 2020 Feb.
  PMID: 32045424
  citation: 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.
  PMID: 33019950
  citation: Statistics Canada Eating out - How often and why [Stats in brief: 11-627-M2019003], Statistics Canada: Ottawa, Ontario. 2019.
  citation: Moubarac, J.C., Ultra-processed foods in Canada: consumption, impact on diet quality and policy implications. University of Montreal: Montreal. 2017.
  citation: Yang Y, Weippert M, Ahmed M, L'Abbe MR. Cross-Sectional Nutritional Information and Quality of Canadian Chain Restaurant Menu Items in 2020. Am J Prev Med. 2023 Jan;64(1):42-50. doi: 10.1016/j.amepre.2022.07.015. Epub 2022 Sep 22.
  PMID: 36155709
  citation: Murphy SA, Weippert MV, Dickinson KM, Scourboutakos MJ, L'Abbe MR. Cross-Sectional Analysis of Calories and Nutrients of Concern in Canadian Chain Restaurant Menu Items in 2016. Am J Prev Med. 2020 Oct;59(4):e149-e159. doi: 10.1016/j.amepre.2020.05.005. Epub 2020 Aug 20.
  PMID: 32828587
  citation: Vella-Zarb RA, Elgar FJ. The 'freshman 5': a meta-analysis of weight gain in the freshman year of college. J Am Coll Health. 2009 Sep-Oct;58(2):161-6. doi: 10.1080/07448480903221392.
  PMID: 19892653
  citation: Levitsky DA, Halbmaier CA, Mrdjenovic G. The freshman weight gain: a model for the study of the epidemic of obesity. Int J Obes Relat Metab Disord. 2004 Nov;28(11):1435-42. doi: 10.1038/sj.ijo.0802776.
  PMID: 15365585
  citation: Matthews JI, Doerr L, Dworatzek PDN. University Students Intend to Eat Better but Lack Coping Self-Efficacy and Knowledge of Dietary Recommendations. J Nutr Educ Behav. 2016 Jan;48(1):12-19.e1. doi: 10.1016/j.jneb.2015.08.005. Epub 2015 Sep 28.
  PMID: 26424531
  citation: Block JP, Roberto CA. Potential benefits of calorie labeling in restaurants. JAMA. 2014 Sep 3;312(9):887-8. doi: 10.1001/jama.2014.9239. No abstract available.
  PMID: 25077460
  citation: West JH, Belvedere LM, Andreasen R, Frandsen C, Hall PC, Crookston BT. Controlling Your "App"etite: How Diet and Nutrition-Related Mobile Apps Lead to Behavior Change. JMIR Mhealth Uhealth. 2017 Jul 10;5(7):e95. doi: 10.2196/mhealth.7410.
  PMID: 28694241
  citation: McCarroll R, Eyles H, Ni Mhurchu C. Effectiveness of mobile health (mHealth) interventions for promoting healthy eating in adults: A systematic review. Prev Med. 2017 Dec;105:156-168. doi: 10.1016/j.ypmed.2017.08.022. Epub 2017 Sep 4.
  PMID: 28882743
  citation: 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.
  PMID: 32050996
  citation: Pan American Health Organization. Front-of-package labeling [Internet]. Available from: https://www.paho.org/en/topics/front-package-labeling
  responsible party type: Principal Investigator
  investigator affiliation: University of Toronto
  investigator full name: Mary L'Abbe
  investigator title: Professor Emeritus, CM, PhD
  mesh term: Neoplasm Metastasis
  sharing ipd: No