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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04308408
Other study ID # 7-68S4-17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date June 30, 2018

Study information

Verified date March 2020
Source Instituto Nacional de Salud Publica, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The study employed an online grocery store developed for this purpose to simulate a shopping situation.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2105
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Guideline Daily Amounts
All food items displayed the corresponding GDA label in the lower left corner of the front of the package.
Multiple Traffic Light
All food items displayed the corresponding MTL label in the lower left corner of the front of the package.
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.
Video
Participants viewed a short (less than 1 min) video explaining how to interpret the label.

Locations

Country Name City State
Mexico Universidad Autónoma Metropolitana Ciudad de Mexico Ciudad De México
Mexico Univesidad Autónoma de Morelos Cuernavaca Morelos
Mexico Hospital de Alta Especialidad del Bajío León Guanajuato
Mexico Universidad Iberoamericana Mexico City
Mexico Universidad Nacional Autónoma de México Mexico City
Mexico Universidad Autónoma de Nuevo León Monterrey Nuevo León
Mexico Universidad de Monterrey Monterrey Nuevo León
Mexico Universidad Autónoma de San Luis Potosí San Luis Potosí

Sponsors (1)

Lead Sponsor Collaborator
Instituto Nacional de Salud Publica, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. On the date of randomization
Primary 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. On the date of randomization
Secondary 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 On the date of randomization, after completion of the online shopping simulation
Secondary 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 On the date of randomization, after completion of the online shopping simulation
Secondary 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 On the date of randomization, after completion of the online shopping simulation
Secondary 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 On the date of randomization, after completion of the online shopping simulation
Secondary 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. On the date of randomization, after completion of the online shopping simulation
Secondary 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 On the date of randomization, after completion of the online shopping simulation
Secondary 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 On the date of randomization, after completion of the online shopping simulation
Secondary Time to first product selection (minutes) Calculated as the time required to "buy" a product after entering the online grocery store. On the date of randomization, during the online shopping simulation
Secondary 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 On the date of randomization, during the online shopping simulation
Secondary 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 On the date of randomization, during the online shopping simulation
Secondary Total time spent shopping (minutes) Calculated as the time spent shopping, between entering and exiting the online grocery store. On the date of randomization, after completion of the online shopping simulation
See also
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Completed NCT02385838 - Impact of Nutrition Labels on Consumer Purchasing Intentions N/A
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