Front of Pack Nutritional Labeling of Processed Foods Among Mexican Consumers
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ClinicalTrials.gov Identifier: NCT04308408 |
Recruitment Status :
Completed
First Posted : March 16, 2020
Last Update Posted : March 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Food Labeling | Behavioral: Guideline Daily Amounts Behavioral: Multiple Traffic Light Behavioral: Warning Labels Behavioral: Video | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2105 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Front of Pack Nutritional Labeling of Processed Foods Among Mexican Consumers |
Actual Study Start Date : | May 1, 2018 |
Actual Primary Completion Date : | June 30, 2018 |
Actual Study Completion Date : | June 30, 2018 |

Arm | Intervention/treatment |
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Active Comparator: Mexican Guideline Daily Allowance (GDA)
Guideline Daily Amounts (GDA) is a purely numerical and reductive labeling system, indicates the grams and percentages (according to the guideline-based daily intakes) per portion of kilocalories, saturated fats, other fats, sugars, and sodium, with no specific judgement, opinion or recommendation.
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Behavioral: Guideline Daily Amounts
All food items displayed the corresponding GDA label in the lower left corner of the front of the package. Behavioral: Video Participants viewed a short (less than 1 min) video explaining how to interpret the label. |
Experimental: Ecuador's Multiple Traffic Light (MTL)
Multiple traffic light labels, an interpretive nutrient-specific FOP label, use the typical traffic light colors (green, yellow/amber, red) and text descriptors to indicate the high, medium, or low content of total fat, sugar and salt.
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Behavioral: Multiple Traffic Light
All food items displayed the corresponding MTL label in the lower left corner of the front of the package. Behavioral: Video Participants viewed a short (less than 1 min) video explaining how to interpret the label. |
Experimental: Chilean Warning Labels in Red
Warning Labels (WL), another nutrient-specific interpretive FOP labelling scheme, include 'high in' symbols for products that exceed limits of energy, sodium, sugar and saturated fat.
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Behavioral: Warning Labels
Food products were labeled with "High in" labels In the lower left corner of the front of the package. In total, 37 of the 60 food products in the shopping site did not display a WL. Behavioral: Video Participants viewed a short (less than 1 min) video explaining how to interpret the label. |
- Mean nutritional quality of the shopping cart [ Time Frame: On the date of randomization ]The Nutrient Profiling Scoring Criterion model was used as the main measure to evaluate the nutritional quality of the shopping cart.
- Mean nutritional quality of the shopping cart (negative nutrients) [ Time Frame: On the date of randomization ]The Nutrient Profiling Scoring Criterion baseline score, considering only negative nutrients, was used to explore a nutritional quality measure consistent with the key nutrients evaluated.
- Mean protein content [ Time Frame: On the date of randomization, after completion of the online shopping simulation ]The mean protein content per 100g or 100 mL of the purchased items was calculated by dividing the total protein content in the shopping cart by the number of products purchased
- Mean fiber content [ Time Frame: On the date of randomization, after completion of the online shopping simulation ]The mean fiber content per 100g or 100 mL of the purchased items was calculated by dividing the total fiber content in the shopping cart by the number of products purchased
- Mean sodium content [ Time Frame: On the date of randomization, after completion of the online shopping simulation ]The mean sodium content per 100g or 100 mL of the purchased items was calculated by dividing the total sodium content in the shopping cart by the number of products purchased
- Mean sugar content [ Time Frame: On the date of randomization, after completion of the online shopping simulation ]The mean sugar content per 100g or 100 mL of the purchased items was calculated by dividing the total sugar content in the shopping cart by the number of products purchased
- Mean saturated fat content [ Time Frame: On the date of randomization, after completion of the online shopping simulation ]The mean saturated fat content per 100g or 100 mL of the purchased items was calculated by dividing the total saturated fat content in the shopping cart by the number of products purchased.
- Mean energy content [ Time Frame: On the date of randomization, after completion of the online shopping simulation ]The mean energy content per 100g or 100 mL of the purchased items was calculated by dividing the total energy content in the shopping cart by the number of products purchased
- Mean fat content [ Time Frame: On the date of randomization, after completion of the online shopping simulation ]The mean fat content per 100g or 100 mL of the purchased items was calculated by dividing the total fat content in the shopping cart by the number of products purchased
- Time to first product selection (minutes) [ Time Frame: On the date of randomization, during the online shopping simulation ]Calculated as the time required to "buy" a product after entering the online grocery store.
- Time spent looking at a product before deciding to buy it (seconds) [ Time Frame: On the date of randomization, during the online shopping simulation ]Estimated as the time between observing the food product on the pop-up window and clicking on the "add to shopping cart" button
- Time spent looking at a product before deciding not to buy it (seconds) [ Time Frame: On the date of randomization, during the online shopping simulation ]Estimated as the time between observing the food product on the pop-up window and going back to the shopping shelf
- Total time spent shopping (minutes) [ Time Frame: On the date of randomization, after completion of the online shopping simulation ]Calculated as the time spent shopping, between entering and exiting the online grocery store.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Consuming at least one of the five food groups included in the shopping site (salty snacks, beverages, dairy products, breakfast cereals and ready-made foods)
- Shopping for groceries at least twice per week
Exclusion Criteria:
- Working in the food and beverage industry
- Having any of their direct family members working in the food and beverage industry

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308408
Mexico | |
Universidad Autónoma Metropolitana | |
Ciudad de Mexico, Ciudad De México, Mexico | |
Hospital de Alta Especialidad del Bajío | |
León, Guanajuato, Mexico | |
Univesidad Autónoma de Morelos | |
Cuernavaca, Morelos, Mexico, 62100 | |
Universidad Autónoma de Nuevo León | |
Monterrey, Nuevo León, Mexico | |
Universidad de Monterrey | |
Monterrey, Nuevo León, Mexico | |
Universidad Iberoamericana | |
Mexico City, Mexico | |
Universidad Nacional Autónoma de México | |
Mexico City, Mexico | |
Universidad Autónoma de San Luis Potosí | |
San Luis Potosí, Mexico |
Principal Investigator: | Alejandra Jauregui, ScD | Instituto Nacional de Salud Pública |
Documents provided by Alejandra Jáuregui de la Mota, Instituto Nacional de Salud Publica, Mexico:
Responsible Party: | Alejandra Jáuregui de la Mota, Chair of the Department of Physical Activity and Healthy Lifestyles, Instituto Nacional de Salud Publica, Mexico |
ClinicalTrials.gov Identifier: | NCT04308408 |
Other Study ID Numbers: |
7-68S4-17 |
First Posted: | March 16, 2020 Key Record Dates |
Last Update Posted: | March 17, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual participant data will be made available upon request. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | 2 years after completion of recruitment |
Access Criteria: | Data access requests will be reviewed by the principal investigator. Requestors will be required to sign a Data Acess agreement. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
food labeling nutritional quality label understanding purchasing behavior |