Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 6:55 PM
Study NCT ID:
NCT05842460
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2023-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing "Ultraprocessed" Front-of-package Label Among Brazilian Consumers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078622', 'term': 'Nutrients'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-11', 'size': 32319, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-19T19:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1007}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-08', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Purchase intentions', 'timeFrame': 'Online survey within 20 minutes following completion of a ~10 minute shopping task.', 'description': 'How likely the participant would be to buy products will be measured by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher likelihood of buying products.'}], 'secondaryOutcomes': [{'measure': 'Product healthfulness perceptions', 'timeFrame': 'Online survey within 20 minutes following completion of a ~10 minute shopping task.', 'description': 'How healthy products seem to the participant will be measured by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher perceived product healthfulness.'}, {'measure': 'Product processing status perceptions', 'timeFrame': 'Online survey within 20 minutes following completion of a ~10 minute shopping task.', 'description': 'Whether the participant believes products are ultraprocessed will be measured by survey. Responses options are "no," "yes," and "I\'m not sure."'}, {'measure': 'Message effectiveness perceptions', 'timeFrame': 'Online survey within 20 minutes following completion of a ~10 minute shopping task.', 'description': 'Perceived message effectiveness of the study labels will be measured by survey through a three-item scale. Items inquire about how much the labels discourage the participant from wanting to consume the products, how much the labels make the participant concerned about the health effects of consuming the products, and how much the labels make consuming the products seem unpleasant. Response options are on a 1 to 5 scale, with higher scores representing a higher perceived message effectiveness of the study labels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dietary Exposure']}, 'referencesModule': {'references': [{'pmid': '34933866', 'type': 'BACKGROUND', 'citation': "Cotter T, Kotov A, Wang S, Murukutla N. 'Warning: ultra-processed' - A call for warnings on foods that aren't really foods. BMJ Glob Health. 2021 Dec;6(12):e007240. doi: 10.1136/bmjgh-2021-007240. No abstract available."}, {'pmid': '34444941', 'type': 'BACKGROUND', 'citation': 'Romero Ferreiro C, Lora Pablos D, Gomez de la Camara A. Two Dimensions of Nutritional Value: Nutri-Score and NOVA. Nutrients. 2021 Aug 13;13(8):2783. doi: 10.3390/nu13082783.'}, {'pmid': '39385224', 'type': 'DERIVED', 'citation': 'D\'Angelo Campos A, Ng SW, Duran AC, Khandpur N, Taillie LS, Christon FO, Hall MG. "Warning: ultra-processed": an online experiment examining the impact of ultra-processed warning labels on consumers\' product perceptions and behavioral intentions. Int J Behav Nutr Phys Act. 2024 Oct 9;21(1):115. doi: 10.1186/s12966-024-01664-w.'}], 'seeAlsoLinks': [{'url': 'https://www.medrxiv.org/content/10.1101/2022.11.18.22282494v1', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this experiment is to test the effects an "ultraprocessed" warning label on foods and beverages among Brazilian consumers. The main questions it aims to answer are:\n\n* Do "ultraprocessed" warnings affect Brazilian consumers\' intention to purchase products?\n* Do "ultraprocessed" warnings affect Brazilian consumers\' product perceptions?\n\nParticipants will see images of four products carrying either nutrient warning labels (which are currently mandatory in Brazil) or nutrient warning labels alongside an experimental warning label informing that the product is ultraprocessed. Participants will then answer survey questions about each product. Researchers will compare responses between both arms to determine if the "ultraprocessed" warning significantly changes the effect of nutrient warnings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* 18 years or older,\n* residing in Brazil,\n* responsible for at least 50% of the household's grocery purchases.\n\nExclusion criteria:\n\n* involvement in any pre-testing."}, 'identificationModule': {'nctId': 'NCT05842460', 'briefTitle': 'Testing "Ultraprocessed" Front-of-package Label Among Brazilian Consumers', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Testing the Impact of an "Ultraprocessed" Front-of-package Warning Label Among Brazilian Consumers', 'orgStudyIdInfo': {'id': '23-0151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrient warnings', 'description': "Individuals in this trial arm will see images of products carrying nutrient warnings that are currently included in Brazil's front-of-package labeling scheme.", 'interventionNames': ['Behavioral: Nutrient warning labels']}, {'type': 'EXPERIMENTAL', 'label': 'Nutrient and ultraprocessed warnings', 'description': "Individuals in this trial arm will see images of products carrying nutrient warnings that are currently included in Brazil's front-of-package labeling scheme and an experimental warning stating that the product is ultraprocessed.", 'interventionNames': ['Behavioral: Nutrient and ultraprocessed warning labels']}], 'interventions': [{'name': 'Nutrient warning labels', 'type': 'BEHAVIORAL', 'description': 'Inclusion of nutrient warning labels, which are currently mandatory in Brazil, to images of food products.', 'armGroupLabels': ['Nutrient warnings']}, {'name': 'Nutrient and ultraprocessed warning labels', 'type': 'BEHAVIORAL', 'description': 'Inclusion of nutrient warning labels, which are currently mandatory in Brazil, and an experimental ultraprocessed warning label to images of food products.', 'armGroupLabels': ['Nutrient and ultraprocessed warnings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27516', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Lindsey Taillie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'Upon publication of the study.', 'ipdSharing': 'YES', 'description': 'A deidentified dataset and analytic code will be uploaded to a public repository upon publication of the study.', 'accessCriteria': 'No access criteria. The dataset and analytic code will be made publicly available at Open Science Framework.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Bloomberg Family Foundation, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}