NCT04308408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,105

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 10, 2020

Last Update Submit

March 13, 2020

Conditions

Keywords

food labelingnutritional qualitylabel understandingpurchasing behavior

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (11)

  • Mean protein content

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

  • Mean fiber content

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

  • Mean sodium content

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

  • Mean sugar content

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

  • Mean saturated fat content

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

  • +6 more secondary outcomes

Study Arms (3)

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.

Behavioral: Guideline Daily AmountsBehavioral: 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.

Behavioral: Multiple Traffic LightBehavioral: 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.

Behavioral: Warning LabelsBehavioral: Video

Interventions

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

Mexican Guideline Daily Allowance (GDA)

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

Ecuador's Multiple Traffic Light (MTL)
Warning LabelsBEHAVIORAL

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.

Chilean Warning Labels in Red
VideoBEHAVIORAL

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

Chilean Warning Labels in RedEcuador's Multiple Traffic Light (MTL)Mexican Guideline Daily Allowance (GDA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital de Alta Especialidad del Bajío

León, Guanajuato, Mexico

Location

Universidad Autónoma Metropolitana

Mexico City, Mexico City, Mexico

Location

Univesidad Autónoma de Morelos

Cuernavaca, Morelos, 62100, Mexico

Location

Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, Mexico

Location

Universidad de Monterrey

Monterrey, Nuevo León, Mexico

Location

Universidad Iberoamericana

Mexico City, Mexico

Location

Universidad Nacional Autónoma de México

Mexico City, Mexico

Location

Universidad Autónoma de San Luis Potosí

San Luis Potosí City, Mexico

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Alejandra Jauregui, ScD

    Instituto Nacional de Salud Pública

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of the Department of Physical Activity and Healthy Lifestyles

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 16, 2020

Study Start

May 1, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data will be made available upon request.

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations