Healthy Diet Clinical Trial
Official title:
A Randomized Controlled Trial Using FoodFlip©, a Mobile Phone App, to Promote Healthier Diets and Food Choices Among Post-Secondary Students
Verified date | May 2024 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Department of Nutritional Sciences, University of Toronto | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto |
Canada,
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 all — Click here to view all references
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Not yet recruiting |
NCT05218980 -
Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health
|
N/A | |
Not yet recruiting |
NCT04119791 -
A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice
|
N/A | |
Recruiting |
NCT05660837 -
Online Social Support Program for Physical and Mental Health of Filipino Migrant Domestic Workers in Hong Kong
|
N/A | |
Completed |
NCT05098223 -
Price Promotions on Purchases of Snacks
|
N/A | |
Active, not recruiting |
NCT05400187 -
Body Composition Assessment and Smart-phone Based Counselling on Healthy Eating and Weight Management
|
N/A | |
Completed |
NCT03941392 -
Nutritional Study in Spanish Pediatric Population
|
||
Completed |
NCT03378843 -
Spermidine Intake and All-cause Mortality
|
N/A | |
Completed |
NCT04596254 -
Detection of Gut Metabolites in Mother's Milk Following Juice Intake
|
N/A | |
Completed |
NCT04078646 -
Influence of Proteins on the Bioavailability of Carotenoids
|
N/A | |
Completed |
NCT05351853 -
Metabolic Effects of Plant-based Diet
|
N/A | |
Completed |
NCT04275843 -
The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults
|
N/A | |
Completed |
NCT05619276 -
Acute Intervention to Assess the Impact of Practical Strategies for Healthy Eating
|
N/A | |
Recruiting |
NCT05290064 -
Effect of Ultra-processed Versus Unprocessed Diets on Energy Metabolism
|
N/A | |
Completed |
NCT06119165 -
Impact of Environmental Nudges on Dietary Quality
|
N/A | |
Completed |
NCT03967912 -
MOVE UP Lifestyle Intervention for Caregivers
|
N/A | |
Recruiting |
NCT05657730 -
Study the Effect of Water Kefir Consumption on the Gut Microbiome in Healthy Adults
|
N/A | |
Completed |
NCT05213273 -
Nutritional Study on the Beneficial Effects of Canned Fish Consumption on Healthy Adult Population
|
N/A | |
Active, not recruiting |
NCT04329962 -
Metabolism and Absorption of Anthocyanins From Extract and Whole Blueberry Powder Confections in Healthy Adults
|
N/A | |
Recruiting |
NCT04299685 -
Family Factors of Eating Habits Among Adolescents
|