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临床试验/NCT06102473
NCT06102473尚未招募不适用

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 个研究点目标入组 404 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
404
主要终点
Energy and macronutrient intake

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Energy and macronutrient intake

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Diana Avila Montiel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Diana Avila Montiel

Researcher in Medical Science

Hospital Infantil de Mexico Federico Gomez

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