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

Sponsor

Diana Avila Montiel (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06102473

Collaborator

(none)

404

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Malnutrition, Child	Other: Nutritional education	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

404 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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.

Anticipated Study Start Date :

Apr 1, 2024

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Food and drink selection [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.
Energy and macronutrient intake [1 week before starting the intervention, 3 months and 6 months]
Amount of Kcal consumed, saturated fat, trans fat, sodium, added sugar

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.