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

NCT06102473 | Unknown DMC

• 1 other identifier: HIM/2022/054
• Study Type: interventional
• Target: 404
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity; Malnutrition, Child

Keywords

front-of-package; warning labeling; food selection; children; caregivers; nutritional education

Outcome Measures

Primary Outcomes (2)

• Food and drink selection

  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

  Amount of Kcal consumed, saturated fat, trans fat, sodium, added sugar

  1 week before starting the intervention, 3 months and 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Nutritional education OTHER

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.

Also known as: Educational

Intervention group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Diana Avila Montiel: lead

Related Publications (13)

• Neal B, Crino M, Dunford E, Gao A, Greenland R, Li N, Ngai J, Ni Mhurchu C, Pettigrew S, Sacks G, Webster J, Wu JH. Effects of Different Types of Front-of-Pack Labelling Information on the Healthiness of Food Purchases-A Randomised Controlled Trial. Nutrients. 2017 Nov 24;9(12):1284. doi: 10.3390/nu9121284.

  PMID: 29186803 BACKGROUND

• Machin L, Arrua A, Gimenez A, Curutchet MR, Martinez J, Ares G. Can nutritional information modify purchase of ultra-processed products? Results from a simulated online shopping experiment. Public Health Nutr. 2018 Jan;21(1):49-57. doi: 10.1017/S1368980017001185. Epub 2017 Jul 18.

  PMID: 28716163 BACKGROUND

• Vanderlee L, Franco-Arellano B, Ahmed M, Oh A, Lou W, L'Abbe MR. The efficacy of 'high in' warning labels, health star and traffic light front-of-package labelling: an online randomised control trial. Public Health Nutr. 2021 Jan;24(1):62-74. doi: 10.1017/S1368980020003213. Epub 2020 Oct 6.

  PMID: 33019950 BACKGROUND

• Vilaro MJ, Barnett TE, Mathews A, Pomeranz J, Curbow B. Income differences in social control of eating behaviors and food choice priorities among southern rural women in the US: A qualitative study. Appetite. 2016 Dec 1;107:604-612. doi: 10.1016/j.appet.2016.09.003. Epub 2016 Sep 7.

  PMID: 27612560 BACKGROUND

• Arrua A, Curutchet MR, Rey N, Barreto P, Golovchenko N, Sellanes A, Velazco G, Winokur M, Gimenez A, Ares G. Impact of front-of-pack nutrition information and label design on children's choice of two snack foods: Comparison of warnings and the traffic-light system. Appetite. 2017 Sep 1;116:139-146. doi: 10.1016/j.appet.2017.04.012. Epub 2017 Apr 18.

  PMID: 28428151 BACKGROUND

• Tarabashkina L, Quester P, Crouch R. Exploring the moderating effect of children's nutritional knowledge on the relationship between product evaluations and food choice. Soc Sci Med. 2016 Jan;149:145-52. doi: 10.1016/j.socscimed.2015.11.046. Epub 2015 Dec 8.

  PMID: 26717561 BACKGROUND

• Palfreyman Z, Haycraft E, Meyer C. Parental modelling of eating behaviours: observational validation of the Parental Modelling of Eating Behaviours scale (PARM). Appetite. 2015 Mar;86:31-7. doi: 10.1016/j.appet.2014.08.008. Epub 2014 Aug 8.

  PMID: 25111293 BACKGROUND

• Vilchis-Gil J, Galvan-Portillo M, Klunder-Klunder M, Cruz M, Flores-Huerta S. Food habits, physical activities and sedentary lifestyles of eutrophic and obese school children: a case-control study. BMC Public Health. 2015 Feb 11;15:124. doi: 10.1186/s12889-015-1491-1.

  PMID: 25885348 BACKGROUND

• Rodriguez-Ramirez S, Mundo-Rosas V, Garcia-Guerra A, Shamah-Levy T. Dietary patterns are associated with overweight and obesity in Mexican school-age children. Arch Latinoam Nutr. 2011 Sep;61(3):270-8.

  PMID: 22696895 BACKGROUND

• Hawkes C, Smith TG, Jewell J, Wardle J, Hammond RA, Friel S, Thow AM, Kain J. Smart food policies for obesity prevention. Lancet. 2015 Jun 13;385(9985):2410-21. doi: 10.1016/S0140-6736(14)61745-1. Epub 2015 Feb 19.

  PMID: 25703109 BACKGROUND

• Monasta L, Batty GD, Macaluso A, Ronfani L, Lutje V, Bavcar A, van Lenthe FJ, Brug J, Cattaneo A. Interventions for the prevention of overweight and obesity in preschool children: a systematic review of randomized controlled trials. Obes Rev. 2011 May;12(5):e107-18. doi: 10.1111/j.1467-789X.2010.00774.x.

  PMID: 20576004 BACKGROUND

• Walley AJ, Asher JE, Froguel P. The genetic contribution to non-syndromic human obesity. Nat Rev Genet. 2009 Jul;10(7):431-42. doi: 10.1038/nrg2594.

  PMID: 19506576 BACKGROUND

• Avila-Montiel D, Vilchis-Gil J, Miranda-Lora AL, Velazquez-Lopez L, Klunder-Klunder M. The Effects of an Educational Intervention About Front-of-Package Labeling on Food and Beverage Selection Among Children and Their Caregivers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 1;13:e54783. doi: 10.2196/54783.

  PMID: 38557591 DERIVED

Related Links

• National Health Survey
• Front of package labeling of food and beverages

MeSH Terms

Conditions

Overweight; Obesity; Child Nutrition Disorders; Food Preferences

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Miguel Klünder-Klünder, PhD

  Hospital Infantil de Mexico Federico Gomez

  STUDY DIRECTOR

Central Study Contacts

Diana Avila-Montiel, MSc

CONTACT

+525552289917; diana.avmo@gmail.com

Jenny Vilchis-Gil, PhD

CONTACT

+525552289917; jvilchisgil@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher in Medical Science

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share