Development of Online Store for Testing Regulatory Food and Nutrition Policies in Brazil

NCT ID: NCT05789238

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3026 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-24
• Study Completion Date: 2023-06-28

Brief Summary

The purpose of this randomized controlled trial is to assess the impact of different nutrient profiles for magnifying glass front-of-package labels (FOPLs) on consumer choices in an online grocery store. Participants will be adults residing in Brazil recruited through a survey research firm. Participants will be randomly assigned to one of three shopping environments in an online grocery store. Participants will complete a shopping task (selecting items from a pre-specified shopping list) in the online grocery store. After completing the shopping task, participants will be rerouted to a computer survey. The survey will include standard behavior and label perception questions, as well as demographic items.

Detailed Description

Among noncommunicable disease, cardiovascular-related diseases are the leading cause of death worldwide and contribute to almost one-third of deaths in Brazil. Cardiovascular disease has become the leading cause of death in Brazil since 1960 due in part to poor eating habits, obesity, and insufficient physical activity. Consumption of high levels of sodium, added sugar, and saturated fat is a major driver of the development of cardiovascular disease. In this context, nutrition policies and interventions, such as the use of warning labels, are an important tool for reducing risk of diet-related diseases. The Brazilian Ministry of Health has recently announced efforts to combat the country's growing burden of diet-related noncommunicable diseases, and Brazil's National Health Surveillance Agency (ANVISA) has approved a more transparent and accessible system for communicating nutrition information for foods and beverages. The proposal will require labeling with a magnifying glass symbol on the front of products' packages to inform consumers about excess nutrients (i.e., sodium, sugar, saturated fat). Similar interventions have been implemented across Latin America, including Chile, Peru, and Mexico. A recent study in Chile demonstrated a reduction in purchases of food and drink items displaying warning labels.

This study seeks to test the effectiveness of different nutrient profiles to determine which products should carry the new labels in Brazil (i.e., the Pan-American Health Organization's profile or Brazil's National Health Surveillance Agency's proposed profile). Additionally, it seeks to assess whether the inclusion of information about products' ultra-processed nature further impacts consumers' product perceptions. The study will provide critical information for the Brazilian Ministry of Health on the effectiveness of the new label proposal and on strategies to inform Brazilians of product healthfulness.

Participants will be initially redirected from Cint (an online panel company). Following online consent and completion of a screening survey, participants will be redirected to an experimental online grocery store (Saruê), given a shopping list, and asked to shop for the items on the list as if in a real store. Upon redirection from Cint, participants will be randomly assigned into three arms: 1) control (no FOPLs); 2) FOPLs applied to products based on Brazil's National Health Surveillance Agency (ANVISA)'s nutrient profile model; or 3) front-of-package labels applied to products based on the Pan-American Health Organization (PAHO)'s nutrient profile model. After participants select products and check out, they will answer a survey about their perceptions about the labels and products carrying them. These questions will include self-reported responses to the content (e.g., elaboration, beliefs). After data collection, data on participants' selected products in the online grocery store will be analyzed to determine which nutrient profile was the most effective in decreasing participants' consumption of key nutrients.

Setting: The trial will take place in Saruê, an experimental online grocery store created for researchers to examine how front-of-package labels influence consumer purchases in a controlled but realistic environment. The online store reflects real-world prices and is modeled after Pão de Açúcar, a Brazilian online grocery store .

Recruitment: Participants will be recruited through Cint, a survey research firm. The eligibility criteria are residing in Brazil, being 18 years or older, and being responsible for at least half of the grocery shopping for one's household. Participants are ineligible if they were involved in any pre-testing related to the survey. Experiments conducted using online convenience samples, such as those recruited by Cint, largely replicate findings from studies conducted via probability-based samples. Cint will screen for eligibility and recruit participants from their pool of 8 million participants in Brazil. Approximately 3,000 participants will be recruited. As compensation, participants will receive incentives or points that can be redeemed for gift cards or goods per Cint's protocols.

Informed Consent: Participants will sign an informed consent form that follows a structure that is customary in Brazil.

Randomization: After the participant has signed the consent form, they will be randomly assigned to one of the three study arms. Randomization order will be determined a priori. Participants will have an equal chance of being randomized to each trial arm.

Conditions

Dietary Habits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

No labels for products high in added sugar, saturated fat, or sodium

Group Type: NO_INTERVENTION

No interventions assigned to this group

ANVISA

Levels of added sugars, saturated fat, and sodium, if exceeded according to the Brazil Nutrient Profile Model, will require the magnifying glass FOPL below on the front of the package for either solid food or liquid food.

Group Type: EXPERIMENTAL

ANVISA

Intervention Type: BEHAVIORAL

Products carrying front-of-package labels based on Brazil's Health Regulatory Agency (ANVISA's) nutrient profile model

PAHO

PAHO Model is not based on thresholds (cut-off limits), but by percentage of regulated nutrient values in total calories amount and by NOVA categories. Therefore, the Brazil team has classified products from the dataset into NOVA categories and created calculations to apply the PAHO model to PdeA products.

Group Type: EXPERIMENTAL

PAHO

Intervention Type: BEHAVIORAL

Products carrying front-of-package labels based on the Pan-American Health Organization (PAHO's) nutrient profile model

Interventions

ANVISA

Products carrying front-of-package labels based on Brazil's Health Regulatory Agency (ANVISA's) nutrient profile model

Intervention Type: BEHAVIORAL

PAHO

Products carrying front-of-package labels based on the Pan-American Health Organization (PAHO's) nutrient profile model

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• Resides in Brazil
• Does at least half of the grocery shopping for their household

Exclusion Criteria

• Involved in any pre-testing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Clara Duran, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas

Locations

University of Campinas

Campinas, , Brazil

Countries

Brazil

References

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Reference Type: BACKGROUND

PMID: 26811272 (View on PubMed)

World Health Organization. Noncommunicable Diseases (NCD) Country Profiles: Brazil. Published 2018. Accessed July 28, 2021. https://www.who.int/nmh/countries/bra_en.pdf.

Reference Type: BACKGROUND

Wang YJ, Yeh TL, Shih MC, Tu YK, Chien KL. Dietary Sodium Intake and Risk of Cardiovascular Disease: A Systematic Review and Dose-Response Meta-Analysis. Nutrients. 2020 Sep 25;12(10):2934. doi: 10.3390/nu12102934.

Reference Type: BACKGROUND

PMID: 32992705 (View on PubMed)

Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu FB. Added sugar intake and cardiovascular diseases mortality among US adults. JAMA Intern Med. 2014 Apr;174(4):516-24. doi: 10.1001/jamainternmed.2013.13563.

Reference Type: BACKGROUND

PMID: 24493081 (View on PubMed)

Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.

Reference Type: BACKGROUND

PMID: 32428300 (View on PubMed)

Agência Nacional de Vigilância Sanitária. Apresentação rotulagem nutricional_19a. Published 2020. Accessed July 28, 2021. https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2020/aprovada-norma-sobre-rotulagem-nutricional/apresentacao-rotulagem-nutricional_19a.pdf/view

Reference Type: BACKGROUND

Cancer Council Australia. Nutrient warning labels. Obesity Evidence Hub website. Published September 9, 2020. Accessed July 28, 2021. https://www.obesityevidencehub.org.au/collections/prevention/nutrient-warning-labels.

Reference Type: BACKGROUND

Correa T, Fierro C, Reyes M, Dillman Carpentier FR, Taillie LS, Corvalan C. "Responses to the Chilean law of food labeling and advertising: exploring knowledge, perceptions and behaviors of mothers of young children". Int J Behav Nutr Phys Act. 2019 Feb 13;16(1):21. doi: 10.1186/s12966-019-0781-x.

Reference Type: BACKGROUND

PMID: 30760273 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

21-2129

Identifier Type: -

Identifier Source: org_study_id