Effect of an Educational Intervention About Front of Package Labeling in Children and Caregivers.

Study Overview
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Brief Summary
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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: 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.

Detailed Description
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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.

Official Title
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Effect of a Digital Educational Intervention About the Front of Package Labeling of Industrialized Foods and Beverages on the Selection and Purchase of Products in Mexican Caregivers and Schoolchildren.

Conditions
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Overweight and Obesity, Malnutrition, Child

Intervention / Treatment
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* Other: Nutritional education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children: 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: Caregivers and children: No Internet Access No computer or mobile devices Who are participating in a weight reduction program, with or without pharmacological treatment

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: Nutritional education<br>* 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.<br>* Other names: Educational;|
| No Intervention: Control Group<br>The dyads (children and caregivers), will receive general nutritional education. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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front-of-package, warning labeling, food selection, children, caregivers, nutritional education