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The goal of this clinical trial is to evaluate the effect of a digital educational intervention of front-of-package warning labeling on the selection and purchase of food in elementary school children and their caregivers.
The main question it aims to answer is:
The intervention will be carried out through a web page with audiovisual material and all participants also will be asked to complete:
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.
Third, fourth, and fifth-grade elementary school students and their caregivers from 4 primary schools, two public and two private, in Mexico City, will participate. The schools will be chosen by simple random sampling. Schools will be randomized into two groups: intervention and control.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control Group | No Intervention | The dyads (children and caregivers), will receive general nutritional education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional education | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Food and drink selection | Percentage of products purchased by each participant in the virtual store, whose content indicates "high in calories", sugar, fat, and sodium" and also average content of these nutrients in 100 g of the products. | 1 week before starting the intervention, 3 months and 6 months |
| Energy and macronutrient intake | Amount of Kcal consumed, saturated fat, trans fat, sodium, added sugar | 1 week before starting the intervention, 3 months and 6 months |
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Inclusion Criteria:
Children:
Caregivers:
Exclusion Criteria:
Caregivers and children:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Avila-Montiel, MSc | Contact | +525552289917 | 4311 | diana.avmo@gmail.com |
| Jenny Vilchis-Gil, PhD | Contact | +525552289917 | 4510 | jvilchisgil@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Klünder-Klünder, PhD | Hospital Infantil de Mexico Federico Gomez | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29186803 | Background | 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. | |
| 28716163 | Background |
| Label | URL |
|---|---|
| National Health Survey | View source |
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There is not a plan to make IPD available
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015362 | Child Nutrition Disorders |
| D005518 | Food Preferences |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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. |
| 33019950 | Background | 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. |
| 27612560 | Background | 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. |
| 28428151 | Background | 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. |
| 26717561 | Background | 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. |
| 25111293 | Background | 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. |
| 25885348 | Background | 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. |
| 22696895 | Background | 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. |
| 25703109 | Background | 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. |
| 20576004 | Background | 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. |
| 19506576 | Background | 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. |
| 38557591 | Derived | 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. |
| Front of package labeling of food and beverages | View source |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |