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

Diana Avila Montiel

Status: Not yet enrolling

Conditions: Malnutrition, Child; Overweight and Obesity

Treatments: Other: Nutritional education

Study type: Interventional

Funder types: Other

Identifiers

NCT06102473

HIM/2022/054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 404 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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404 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Nutritional education

Control Group

No Intervention group

Description:

The dyads (children and caregivers), will receive general nutritional education.