Effect of an Educational Intervention About Front of Package Labeling in Children and Caregivers.
NCT ID: NCT06102473
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
404 participants
INTERVENTIONAL
2024-04-01
2025-05-31
Brief Summary
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The main question it aims to answer is:
* What is the effect of a digital educational intervention on front-of-package warning labeling on food selection in children from primary schools in Mexico City, compared to a control group? Participants will be randomized into two groups.
* The control group, the dyads (caregiver-schoolchildren), will receive general nutritional education.
* The intervention group, will also receive guidance on reading labels and raise awareness about the impact of consuming processed or ultra-processed foods on health.
The intervention will be carried out through a web page with audiovisual material and all participants also will be asked to complete:
* Multiple-choice evaluation (5 questions) to ensure theoretical understanding of the topics
* Lunch register
* 24-hour dietary recall
* Survey of food habits and consumption
* Validated food preference questionnaire
* Anthropometric measurements (Weight, height, waist circumference, body mass index)
* Socioeconomic survey
* Participate in a simulated online selection and shopping of food and beverages.
To see if the digital educational intervention in the front of package warning labeling in children and caregivers will improve the selection and purchase of foods.
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Detailed Description
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After approval from the directors of the primary schools, meetings will be held with parents to invite them to participate, they will be explained the objectives, activities, and duration of the intervention. They will be invited to sign a consent and informed assent, clarifying that their participation is voluntary and they may not continue at any time they wish without affecting their activities at school.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention group
The dyads (children and caregivers), will receive general nutritional education and also receive guidance on the use of front-of-package warning labels and awareness about the impact of the consumption of processed and ultra-processed foods on health.
Nutritional education
With prior authorization from the principals of the elementary schools, meetings will be held with parents to invite them to participate, and the aim, activities, and duration of the intervention will be explained to them. They will be invited to sign a consent and informed assent, clarifying that their participation is voluntary and they may not continue at any time they wish without affecting their activities at school.
Control Group
The dyads (children and caregivers), will receive general nutritional education.
No interventions assigned to this group
Interventions
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Nutritional education
With prior authorization from the principals of the elementary schools, meetings will be held with parents to invite them to participate, and the aim, activities, and duration of the intervention will be explained to them. They will be invited to sign a consent and informed assent, clarifying that their participation is voluntary and they may not continue at any time they wish without affecting their activities at school.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Third, 4th, and 5th grade students, both sexes, enrolled in the selected primary schools.
* Children with normal weight, overweight, and obesity.
* Children who sign the written informed consent.
Caregivers:
* Primary caregivers of any sex for children in 3rd, 4th, and 5th grade
* Caregivers with normal weight, overweight and obesity
* Parents who sign the written informed consent
Exclusion Criteria
* No Internet Access
* No computer or mobile devices
* Who are participating in a weight reduction program, with or without pharmacological treatment
8 Years
12 Years
ALL
Yes
Sponsors
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Diana Avila Montiel
OTHER
Responsible Party
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Diana Avila Montiel
Researcher in Medical Science
Principal Investigators
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Miguel Klünder-Klünder, PhD
Role: STUDY_DIRECTOR
Hospital Infantil de Mexico Federico Gomez
Central Contacts
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References
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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.
Machin L, Arrua A, Gimenez A, Curutchet MR, Martinez J, Ares G. Can nutritional information modify purchase of ultra-processed products? Results from a simulated online shopping experiment. Public Health Nutr. 2018 Jan;21(1):49-57. doi: 10.1017/S1368980017001185. Epub 2017 Jul 18.
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.
Vilaro MJ, Barnett TE, Mathews A, Pomeranz J, Curbow B. Income differences in social control of eating behaviors and food choice priorities among southern rural women in the US: A qualitative study. Appetite. 2016 Dec 1;107:604-612. doi: 10.1016/j.appet.2016.09.003. Epub 2016 Sep 7.
Arrua A, Curutchet MR, Rey N, Barreto P, Golovchenko N, Sellanes A, Velazco G, Winokur M, Gimenez A, Ares G. Impact of front-of-pack nutrition information and label design on children's choice of two snack foods: Comparison of warnings and the traffic-light system. Appetite. 2017 Sep 1;116:139-146. doi: 10.1016/j.appet.2017.04.012. Epub 2017 Apr 18.
Tarabashkina L, Quester P, Crouch R. Exploring the moderating effect of children's nutritional knowledge on the relationship between product evaluations and food choice. Soc Sci Med. 2016 Jan;149:145-52. doi: 10.1016/j.socscimed.2015.11.046. Epub 2015 Dec 8.
Palfreyman Z, Haycraft E, Meyer C. Parental modelling of eating behaviours: observational validation of the Parental Modelling of Eating Behaviours scale (PARM). Appetite. 2015 Mar;86:31-7. doi: 10.1016/j.appet.2014.08.008. Epub 2014 Aug 8.
Vilchis-Gil J, Galvan-Portillo M, Klunder-Klunder M, Cruz M, Flores-Huerta S. Food habits, physical activities and sedentary lifestyles of eutrophic and obese school children: a case-control study. BMC Public Health. 2015 Feb 11;15:124. doi: 10.1186/s12889-015-1491-1.
Rodriguez-Ramirez S, Mundo-Rosas V, Garcia-Guerra A, Shamah-Levy T. Dietary patterns are associated with overweight and obesity in Mexican school-age children. Arch Latinoam Nutr. 2011 Sep;61(3):270-8.
Hawkes C, Smith TG, Jewell J, Wardle J, Hammond RA, Friel S, Thow AM, Kain J. Smart food policies for obesity prevention. Lancet. 2015 Jun 13;385(9985):2410-21. doi: 10.1016/S0140-6736(14)61745-1. Epub 2015 Feb 19.
Monasta L, Batty GD, Macaluso A, Ronfani L, Lutje V, Bavcar A, van Lenthe FJ, Brug J, Cattaneo A. Interventions for the prevention of overweight and obesity in preschool children: a systematic review of randomized controlled trials. Obes Rev. 2011 May;12(5):e107-18. doi: 10.1111/j.1467-789X.2010.00774.x.
Walley AJ, Asher JE, Froguel P. The genetic contribution to non-syndromic human obesity. Nat Rev Genet. 2009 Jul;10(7):431-42. doi: 10.1038/nrg2594.
Avila-Montiel D, Vilchis-Gil J, Miranda-Lora AL, Velazquez-Lopez L, Klunder-Klunder M. The Effects of an Educational Intervention About Front-of-Package Labeling on Food and Beverage Selection Among Children and Their Caregivers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 1;13:e54783. doi: 10.2196/54783.
Related Links
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National Health Survey
Front of package labeling of food and beverages
Other Identifiers
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HIM/2022/054
Identifier Type: -
Identifier Source: org_study_id
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