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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
Sponsor:
Information provided by (Responsible Party):
Alejandra Jáuregui de la Mota, Instituto Nacional de Salud Publica, Mexico

Brief Summary:
The effect of three front of pack (FOP) labeling schemes (Mexican Guideline Daily Amounts (GDA), Ecuador's Multiple Traffic Light (MTL) and Chilean Warning Labels (WL) in red) on purchasing intentions was evaluated using a randomized experiment of an online shopping simulation. The study employed an online grocery store developed for this purpose to simulate a shopping situation.

Condition or disease Intervention/treatment Phase
Food Labeling Behavioral: Guideline Daily Amounts Behavioral: Multiple Traffic Light Behavioral: Warning Labels Behavioral: Video Not Applicable

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Food Labeling

Arm Intervention/treatment
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.
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.
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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

  11. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Investigators
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Principal Investigator: Alejandra Jauregui, ScD Instituto Nacional de Salud Pública
  Study Documents (Full-Text)

Documents provided by Alejandra Jáuregui de la Mota, Instituto Nacional de Salud Publica, Mexico:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandra Jáuregui de la Mota, Instituto Nacional de Salud Publica, Mexico:
food labeling
nutritional quality
label understanding
purchasing behavior