Clinical trial NCT06102473: Effect of an Educational Intervention About Front of Package Labeling in Children and Caregivers.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Malnutrition, Child
Keywords: front-of-package
warning labeling
food selection
children
caregivers
nutritional education
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 404
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Food and drink selection
timeFrame: 1 week before starting the intervention, 3 months and 6 months
measure: Energy and macronutrient intake
timeFrame: 1 week before starting the intervention, 3 months and 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Infantil de Mexico Federico Gomez
name: Miguel Klünder-Klünder, PhD
role: STUDY_DIRECTOR
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