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Clinical Trial Summary

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: - 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06102473
Study type Interventional
Source Hospital Infantil de Mexico Federico Gomez
Contact Diana Avila-Montiel, MSc
Phone +525552289917
Email diana.avmo@gmail.com
Status Not yet recruiting
Phase N/A
Start date April 1, 2024
Completion date May 2025

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