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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06033911
Other study ID # 508519
Secondary ID CIHR UD1-170157
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 29, 2024
Est. completion date May 2024

Study information

Verified date May 2024
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 133
Est. completion date May 2024
Est. primary completion date April 22, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
FoodFlip© App with no nutrition symbol
Intervention control: participants will have access to food information such as calories or the Nutrition Facts table through FoodFlip©
FoodFlip© App with 'high-in' nutrition symbol
Intervention: Participants will have access to food information through FoodFlip© with Canada's 'high-in' NS

Locations

Country Name City State
Canada Department of Nutritional Sciences, University of Toronto Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (20)

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. — View 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. — View 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. — View 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.

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. — View 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. — View 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. — View Citation

Moubarac, J.C., Ultra-processed foods in Canada: consumption, impact on diet quality and policy implications. University of Montreal: Montreal. 2017.

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. — View 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. — View Citation

Pan American Health Organization. Front-of-package labeling [Internet]. Available from: https://www.paho.org/en/topics/front-package-labeling

Statistics Canada Eating out - How often and why [Stats in brief: 11-627-M2019003], Statistics Canada: Ottawa, Ontario. 2019.

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. — View 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. — View 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. — View 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. — View 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. — View 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.

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/.

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. — View Citation

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Purchasing Behaviors 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
Primary Nutritional Knowledge 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
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