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Food LabelingNCT04308408

Front of Pack Nutritional Labeling of Processed Foods Among Mexican Consumers

A study testing Guideline Daily Amounts, Multiple Traffic Light and Warning Labels in people with Food Labeling, run by Instituto Nacional de Salud Publica, Mexico at 8 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Food Labeling
What is being tested?
Guideline Daily Amounts, Multiple Traffic Light and Warning Labels
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,105 participants
Where
8 sitesMexico
Study dates
1 May 2018to 30 Jun 2018
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Working in the food and beverage industry
  • Having any of their direct family members working in the food and beverage industry

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Mexico8 sites
  • Univesidad Autónoma de Morelos

    Cuernavaca, Morelos, 62100

  • Hospital de Alta Especialidad del Bajío

    León, Guanajuato

  • Universidad Autónoma Metropolitana

    Mexico City, Mexico City

  • Universidad Iberoamericana

    Mexico City

  • Universidad Nacional Autónoma de México

    Mexico City

  • Universidad Autónoma de Nuevo León

    Monterrey, Nuevo León

  • Universidad de Monterrey

    Monterrey, Nuevo León

  • Universidad Autónoma de San Luis Potosí

    San Luis Potosí City

Other trials in Mexico

About this study

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.

Read the detailed description

Nutrition labels may modify purchasing behavior. Different labels may influence consumer purchasing behaviors in different ways.

In general, for nutrition labels to have any effect on purchasing decisions, consumers must first be exposed to them and perceive the displayed information on the labels. Then, the effect will be mediated by consumer understanding. Based on this understanding, consumers may use the label to make inferences about the nutritional quality or healthiness of the product, which, together with other information (e.g. trust or liking of the label or taste of the product) may affect the evaluation of the product and eventually the purchase decision of the product.

GDA provide numeric information on the content of key nutrients in the food product without interpreting the information.

MTL and WL are nutrient-specific labels providing an interpretation of the nutritional content of specific nutrients in the product. The MTL uses traffic light colors to indicate the high (red) or low (green) content of key nutrients, whereas the WL are only included in a product when the content of each key ingredient is above specific criteria.

Trained undergraduate student research assistants from eight universities across the country recruited the study participants. Research assistants were trained on how to approach and recruit participants and obtain informed consent. They were instructed to recruit 20 or more participants each. Recruitment took place in public spaces previously selected by convenience by the research team, based on their use by low- and middle-income groups in Mexico (i.e., public schools, public squares, public health centers, as well as supermarket chains and shopping centers located in low-income neighborhoods). Potential participants were approached by research assistants, who explained study objectives and invited them to be part of the study. Then, individuals were screened for eligibility using a 3-item screener. To access this screener, research assistants used a tablet or laptop with internet-access, to access a unique web address where our web-based tool was hosted. Research assistants were automatically informed by the web-based tool about the eligibility of the participant. Informed consent was obtained from all eligible participants using an automated computer-based form. Then, the tablet or laptop was handed to participants, who completed a self-administered online demographic and health survey, and then accessed the online shopping site to simulate a shopping situation. Participants completed the shopping task on the same day at the public place where they were recruited.

After allocation, participants viewed a video explaining how to correctly interpret the assigned label. Each participant was asked to shop freely, to better mimic real-world grocery shopping conditions. Research assistants instructed participants as follows: "take into account the assigned label and choose your preferred products". Participants were assigned an initial budget to do their shopping, although they did not pay actual money for their groceries. This budget corresponded to their weekly expenditure in groceries reported in the demographic survey, from 500-5000 Mexican pesos ($28-280 USD), in multiples of 500. No specific instructions were given related to the number or total cost of food products purchased.

FOP nutrition labels were affixed on the food items of the virtual supermarket. The store displayed the name, price and the front of the pack image of 60 food products from 5 food groups (ready-made foods, dairy products, non-dairy beverages, salty snacks, and breakfast cereals). Products were shown on traditional shopping shelves. Participants could zoom in to look more closely at the products and their prices, and could click on the product to access a new pop-up window. This new window displayed product information (i.e., name and brand), a larger image of the front of the product packaging, and an area where they could select the amount or number of products they wanted to put in their shopping cart. The pop-up window was the only way in which participants could select the food products to "purchase". Participants could also zoom in further on this pop-up to look more closely at the package and the nutritional label.

After completing their shopping, participants revised their shopping cart and "purchased" their products. A brief feedback on the nutritional quality of the products in their shopping cart was provided as a retribution for their time.

Conditions
Food Labeling
Being tested
Guideline Daily Amounts, Multiple Traffic Light, Warning Labels, Video
Keywords
food labeling, nutritional quality, label understanding, purchasing behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guideline Daily AmountsBehavioural

    All food items displayed the corresponding GDA label in the lower left corner of the front of the package.

  • Multiple Traffic LightBehavioural

    All food items displayed the corresponding MTL label in the lower left corner of the front of the package.

  • Warning LabelsBehavioural

    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.

  • VideoBehavioural

    Participants viewed a short (less than 1 min) video explaining how to interpret the label.

Study groups in NCT04308408
Study groupRoleWhat they receive
Mexican Guideline Daily Allowance (GDA)Active comparatorGuideline 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.
Receives: Behavioral: Guideline Daily Amounts; Behavioral: Video
Ecuador's Multiple Traffic Light (MTL)ExperimentalMultiple 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.
Receives: Behavioral: Multiple Traffic Light; Behavioral: Video
Chilean Warning Labels in RedExperimentalWarning 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.
Receives: Behavioral: Warning Labels; Behavioral: Video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean nutritional quality of the shopping cart

    The Nutrient Profiling Scoring Criterion model was used as the main measure to evaluate the nutritional quality of the shopping cart.

    Measured: On the date of randomization

  2. Mean nutritional quality of the shopping cart (negative nutrients)

    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.

    Measured: On the date of randomization

Secondary outcomes (11)
  1. Mean protein content

    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

    Measured: On the date of randomization, after completion of the online shopping simulation

  2. Mean fiber content

    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

    Measured: On the date of randomization, after completion of the online shopping simulation

  3. Mean sodium content

    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

    Measured: On the date of randomization, after completion of the online shopping simulation

  4. Mean sugar content

    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

    Measured: On the date of randomization, after completion of the online shopping simulation

  5. Mean saturated fat content

    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.

    Measured: On the date of randomization, after completion of the online shopping simulation

  6. Mean energy content

    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

    Measured: On the date of randomization, after completion of the online shopping simulation

  7. Mean fat content

    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

    Measured: On the date of randomization, after completion of the online shopping simulation

  8. Time to first product selection (minutes)

    Calculated as the time required to "buy" a product after entering the online grocery store.

    Measured: On the date of randomization, during the online shopping simulation

  9. Time spent looking at a product before deciding to buy it (seconds)

    Estimated as the time between observing the food product on the pop-up window and clicking on the "add to shopping cart" button

    Measured: On the date of randomization, during the online shopping simulation

  10. Time spent looking at a product before deciding not to buy it (seconds)

    Estimated as the time between observing the food product on the pop-up window and going back to the shopping shelf

    Measured: On the date of randomization, during the online shopping simulation

  11. Total time spent shopping (minutes)

    Calculated as the time spent shopping, between entering and exiting the online grocery store.

    Measured: On the date of randomization, after completion of the online shopping simulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2020
  2. Study start1 May 2018
  3. Primary completion30 Jun 2018
  4. Study completion30 Jun 2018

Resources

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
Double blind
Who is masked
Care provider, Investigator
Enrolment
2,105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04308408
Sponsor's protocol ID
7-68S4-17
Status last verified
Mar 2020
First submitted
10 Mar 2020
Last updated
17 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data will be made available upon request.

Publications

  • Jauregui A, Vargas-Meza J, Nieto C, Contreras-Manzano A, Alejandro NZ, Tolentino-Mayo L, Hall MG, Barquera S. Impact of front-of-pack nutrition labels on consumer purchasing intentions: a randomized experiment in low- and middle-income Mexican adults. BMC Public Health. 2020 Apr 6;20(1):463. doi: 10.1186/s12889-020-08549-0.

    PubMed 32252716

Questions about this trial

What is this clinical trial studying?

A study testing Guideline Daily Amounts, Multiple Traffic Light and Warning Labels in people with Food Labeling, run by Instituto Nacional de Salud Publica, Mexico at 8 sites in Mexico.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean nutritional quality of the shopping cart (time frame: On the date of randomization). 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 NCT04308408, which also lists 1 linked publication.

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 17 Mar 2020.

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