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

NCT05789238 | Completed

• 1 other identifier: 21-2129
• Study Type: interventional
• Target: 3,026
• Locations: 1 country
• Sites: 1

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.

Conditions

Dietary Habits

Keywords

front-of-package labels; ANVISA; PAHO

Outcome Measures

Primary Outcomes (3)

• Total sugar purchased

  Total grams of sugar of products in a participant's shopping basket. This will be calculated by adding together the total sugar from each product in the participant's shopping basket. Sugar for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.

  At completion of ~20 minute shopping task

• Total saturated fat purchased

  Total grams of saturated fat of products in a participant's shopping basket. This will be calculated by adding together the total saturated fat from each product in the participant's shopping basket. Saturated fat for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.

  At completion of ~20 minute shopping task

• Total sodium purchased

  Total milligrams of sodium of products in a participant's shopping basket. This will be calculated by adding together the total sodium from each product in the participant's shopping basket. Sodium for each product will come from the product's nutrition facts panel. All products in the store are real life products that have designated nutrition facts panels.

  At completion of ~20 minute shopping task

Secondary Outcomes (6)

• Percentage of ultra-processed products purchased

  At completion of ~20 minute shopping task

• Perceived healthfulness of unhealthy products

  ~10 minute post-test computer survey following the ~20 minute shopping task

• Perceived product appeal of unhealthy products

  ~10 minute post-test computer survey following the ~20 minute shopping task

• Health concerns of unhealthy products

  ~10 minute post-test computer survey following the ~20 minute shopping task

• Correct identification of high sugar/saturated fat/sodium content of unhealthy products

  ~10 minute post-test computer survey following the ~20 minute shopping task

Study Arms (3)

Control

NO INTERVENTION

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

ANVISA

EXPERIMENTAL

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.

Behavioral: ANVISA

PAHO

EXPERIMENTAL

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.

Behavioral: PAHO

Interventions

ANVISA BEHAVIORAL

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

ANVISA

PAHO BEHAVIORAL

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

PAHO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Involved in any pre-testing

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Campinas, Brazil: collaborator

Study Sites (1)

University of Campinas

Campinas, Brazil

Location

Related Publications (8)

• Ribeiro AL, Duncan BB, Brant LC, Lotufo PA, Mill JG, Barreto SM. Cardiovascular Health in Brazil: Trends and Perspectives. Circulation. 2016 Jan 26;133(4):422-33. doi: 10.1161/CIRCULATIONAHA.114.008727.

  PMID: 26811272 BACKGROUND

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

  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.

  PMID: 32992705 BACKGROUND

• 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.

  PMID: 24493081 BACKGROUND

• 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.

  PMID: 32428300 BACKGROUND

• 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

  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.

  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.

  PMID: 30760273 BACKGROUND

MeSH Terms

Conditions

Feeding Behavior

Interventions

Pan American Health Organization

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

World Health Organization; United Nations; International Agencies; Organizations; Health Care Economics and Organizations

Study Officials

• Ana Clara Duran, PhD

  University of Campinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: May 24, 2023
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)