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

October 25, 2023 updated by: Diana Avila Montiel

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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
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.
Other Names:
  • Educational
No Intervention: Control Group
The dyads (children and caregivers), will receive general nutritional education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week before starting the intervention, 3 months and 6 months
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
1 week before starting the intervention, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diana Avila Montiel

Investigators

  • Study Director: Miguel Klünder-Klünder, PhD, Hospital Infantil de Mexico Federico Gomez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIM/2022/054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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