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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Mexican Guideline Daily Allowance (GDA) | Active comparator | 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. Receives: Behavioral: Guideline Daily Amounts; Behavioral: Video |
| Ecuador's Multiple Traffic Light (MTL) | Experimental | 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. Receives: Behavioral: Multiple Traffic Light; Behavioral: Video |
| Chilean Warning Labels in Red | Experimental | 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. Receives: Behavioral: Warning Labels; Behavioral: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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
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
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
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
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
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
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.
- First posted16 Mar 2020
- Study start1 May 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food LabelingStudies 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 2,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandra Jáuregui de la Mota, Instituto Nacional de Salud Publica, Mexico
- Investigators
- Alejandra Jauregui, ScD, Principal investigator, Instituto Nacional de Salud Pública
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Front of Pack Nutritional Labeling of Processed Foods Among Mexican Consumers
- ClinicalTrials.gov ID
- NCT04308408
- Acronym / sponsor ID
- 7-68S4-17
- Conditions
- Food Labeling
- Keywords
- food labeling, nutritional quality, label understanding, purchasing behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,105 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Mar 2020 (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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mexican Guideline Daily Allowance (GDA) | Active comparator | Behavioral: Guideline Daily Amounts, Behavioral: VideoGuideline 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. |
| Ecuador's Multiple Traffic Light (MTL) | Experimental | Behavioral: Multiple Traffic Light, Behavioral: VideoMultiple 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. |
| Chilean Warning Labels in Red | Experimental | Behavioral: Warning Labels, Behavioral: VideoWarning 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Working in the food and beverage industry
- Having any of their direct family members working in the food and beverage industry
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 |
|---|---|---|
| Guideline Daily AmountsAll food items displayed the corresponding GDA label in the lower left corner of the front of the package. | Behavioural | Mexican Guideline Daily Allowance (GDA) |
| Multiple Traffic LightAll food items displayed the corresponding MTL label in the lower left corner of the front of the package. | Behavioural | Ecuador's Multiple Traffic Light (MTL) |
| Warning LabelsFood 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. | Behavioural | Chilean Warning Labels in Red |
| VideoParticipants viewed a short (less than 1 min) video explaining how to interpret the label. | Behavioural | Chilean Warning Labels in Red, Ecuador's Multiple Traffic Light (MTL), Mexican Guideline Daily Allowance (GDA) |
Primary outcome
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.
11 secondary outcomes
Mean protein content
Time frame: On the date of randomization, after completion of the online shopping simulation
Mean fiber content
Time frame: On the date of randomization, after completion of the online shopping simulation
Mean sodium content
Time frame: On the date of randomization, after completion of the online shopping simulation
Mean sugar content
Time frame: On the date of randomization, after completion of the online shopping simulation
Mean saturated fat content
Time frame: On the date of randomization, after completion of the online shopping simulation
Mean energy content
Time frame: On the date of randomization, after completion of the online shopping simulation
Mean fat content
Time frame: On the date of randomization, after completion of the online shopping simulation
Time to first product selection (minutes)
Time frame: On the date of randomization, during the online shopping simulation
Time spent looking at a product before deciding to buy it (seconds)
Time frame: On the date of randomization, during the online shopping simulation
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
Total time spent shopping (minutes)
Time frame: On the date of randomization, after completion of the online shopping simulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 32252716Jauregui 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available upon request.
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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.
Alejandra Jauregui, ScD principal investigator
Instituto Nacional de Salud Pública
8 sites in 1 country: see every site and its status.
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.