- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06033911
Using FoodFlip© to Improve Food Choices Among Post-secondary Students
March 25, 2025 updated by: Mary L'Abbe, University of Toronto
A Randomized Controlled Trial Using FoodFlip©, a Mobile Phone App, to Promote Healthier Diets and Food Choices Among Post-Secondary Students
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
133
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
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 1A8
- Department of Nutritional Sciences, 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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- ≥18 years of age
- enrolled at UofT
- have regular access to either iPhone or Android
- purchases at least one meal a day on campus
- able to speak and read English
- not currently pregnant or in lactation
Exclusion Criteria:
- <18 years of age
- not enrolled at UofT
- does not have access to a smartphone
- does not purchase at least one meal a day on campus
- unable to speak and read English
- currently pregnant or in lactation
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No App
No intervention.
Participants will be given access to a web-based submission portal.
|
|
|
Placebo Comparator: FoodFlip© App with no nutrition symbol
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.
|
Intervention control: participants will have access to food information such as calories or the Nutrition Facts table through FoodFlip©
|
|
Active Comparator: FoodFlip© App with 'high-in' nutrition symbol
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: Participants will have access to food information through FoodFlip© with Canada's 'high-in' NS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Purchasing Behaviors
Time Frame: 2 weeks
|
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).
|
2 weeks
|
|
Nutritional Knowledge
Time Frame: 2 weeks
|
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.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mary R L'Abbe, PhD, University of Toronto
- Study Director: Hayun Jeong, HBSc, 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
- 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.
- 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.
- 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.
- 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/.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Statistics Canada Eating out - How often and why [Stats in brief: 11-627-M2019003], Statistics Canada: Ottawa, Ontario. 2019.
- Moubarac, J.C., Ultra-processed foods in Canada: consumption, impact on diet quality and policy implications. University of Montreal: Montreal. 2017.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Pan American Health Organization. Front-of-package labeling [Internet]. Available from: https://www.paho.org/en/topics/front-package-labeling
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)
January 29, 2024
Primary Completion (Actual)
April 22, 2024
Study Completion (Actual)
May 1, 2024
Study Registration Dates
First Submitted
September 5, 2023
First Submitted That Met QC Criteria
September 5, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 30, 2025
Last Update Submitted That Met QC Criteria
March 25, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 508519
- CIHR UD1-170157 (Other Grant/Funding Number: Canadian Institutes of Health Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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