Overweight and ObesityNCT06102473
Effect of an Educational Intervention About Front of Package Labeling in Children and Caregivers.
A study testing Nutritional education in people with Overweight and Obesity and Malnutrition, Child, run by Diana Avila Montiel.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Malnutrition, Child
- What is being tested?
- Nutritional education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
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:
Read more
- 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.
Read the 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.
- Conditions
- Overweight and Obesity, Malnutrition, Child
- Being tested
- Nutritional education
- Keywords
- front-of-package, warning labeling, food selection, children, caregivers, nutritional education
- Medical subject headings
- Overweight, Obesity, Child Nutrition Disorders, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional educationOther
Also called Educational
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nutritional education |
| Control Group | No intervention | The dyads (children and caregivers), will receive general nutritional education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 week before starting the intervention, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Apr 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diana Avila Montiel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diana Avila Montiel, Hospital Infantil de Mexico Federico Gomez
- Investigators
- Miguel Klünder-Klünder, PhD, Study director, Hospital Infantil de Mexico Federico Gomez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102473
- Sponsor's protocol ID
- HIM/2022/054
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
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.
PubMed 29186803Machin 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.
PubMed 28716163Vanderlee 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.
PubMed 33019950Vilaro 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.
PubMed 27612560Arrua 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.
PubMed 28428151Tarabashkina 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.
PubMed 26717561Palfreyman 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.
PubMed 25111293Vilchis-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.
PubMed 25885348Rodriguez-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.
PubMed 22696895Hawkes 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.
PubMed 25703109Monasta 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.
PubMed 20576004Walley 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.
PubMed 19506576Avila-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.
PubMed 38557591
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06102473
- Acronym / sponsor ID
- HIM/2022/054
- Conditions
- Overweight and Obesity, Malnutrition, Child
- Keywords
- front-of-package, warning labeling, food selection, children, caregivers, nutritional education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Diana Avila MontielUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Nutritional educationThe 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. |
| Control Group | No intervention | –The dyads (children and caregivers), will receive general nutritional education. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
- Primary caregivers of any sex for children in 3rd, 4th, and 5th grade
- Caregivers with normal weight, overweight and obesity
Key exclusion criteria (4 listed)
- No Internet Access
- No computer or mobile devices
- Who are participating in a weight reduction program, with or without pharmacological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional educationAlso: EducationalWith 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 | Intervention group |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Background: PubMed 29186803Neal 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.
- Background: PubMed 28716163Machin 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.
- Background: PubMed 33019950Vanderlee 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.
- Background: PubMed 27612560Vilaro 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.
- Background: PubMed 28428151Arrua 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.
- Background: PubMed 26717561Tarabashkina 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.
- Background: PubMed 25111293Palfreyman 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.
- Background: PubMed 25885348Vilchis-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.
- Background: PubMed 22696895Rodriguez-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.
- Background: PubMed 25703109Hawkes 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.
- Background: PubMed 20576004Monasta 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.
- Background: PubMed 19506576Walley 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.
- National Health SurveyLink provided by the sponsor.
- Front of package labeling of food and beveragesLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Klünder-Klünder, PhD study director
Hospital Infantil de Mexico Federico Gomez
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional education in people with Overweight and Obesity and Malnutrition, Child, run by Diana Avila Montiel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Avila-Montiel, MSc (+525552289917 ext. 4311, diana.avmo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food and drink selection (time frame: 1 week before starting the intervention, 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06102473, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.