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Clinical Trials/NCT06102473
NCT06102473
Not Yet Recruiting
N/A

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.

Diana Avila Montiel0 sites404 target enrollmentApril 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
Diana Avila Montiel
Enrollment
404
Primary Endpoint
Energy and macronutrient intake
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
May 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Diana Avila Montiel
Responsible Party
Sponsor Investigator
Principal Investigator

Diana Avila Montiel

Researcher in Medical Science

Hospital Infantil de Mexico Federico Gomez

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Energy and macronutrient intake

Time Frame: 1 week before starting the intervention, 3 months and 6 months

Amount of Kcal consumed, saturated fat, trans fat, sodium, added sugar

Food and drink selection

Time Frame: 1 week before starting the intervention, 3 months and 6 months

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.

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