Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-11 @ 6:36 AM
Study NCT ID:
NCT03336151
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2017-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FOP Nutrition Label in Campus Cafeteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'After a control period with no specific front-of-pack labeling, the intervention consists in the apposition of a front-of-pack labeling (Nutri-Score) to individual foods in a campus cafeteria. All foods are individually labeled.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2017-11-03', 'studyFirstSubmitQcDate': '2017-11-07', 'lastUpdatePostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall nutritional quality of purchases', 'timeFrame': 'Every 15 days, up to 6 months', 'description': 'Overall nutritional quality of purchases evaluated using the Food Standard Agency nutrient profiling system'}], 'secondaryOutcomes': [{'measure': 'Energy content of purchases', 'timeFrame': 'Every 15 days, up to 6 months', 'description': 'Energy content of the purchases (kcal/100g)'}, {'measure': 'Saturated fat content of purchases', 'timeFrame': 'Every 15 days, up to 6 months', 'description': 'Saturated fat content of the purchases (g/100g)'}, {'measure': 'Sugar content of purchases', 'timeFrame': 'Every 15 days, up to 6 months', 'description': 'Sugar content of the purchases (g/100g)'}, {'measure': 'Sodium content of purchases', 'timeFrame': 'Every 15 days, up to 6 months', 'description': 'Sodium content of the purchases (g/100g)'}, {'measure': 'Fiber content of purchases', 'timeFrame': 'Every 15 days, up to 6 months', 'description': 'Fiber content of the purchases (g/100g)'}, {'measure': 'Protein content of purchases', 'timeFrame': 'Every 15 days, up to 6 months', 'description': 'Protein content of the purchases (g/100g)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Labelling']}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of the introduction of a front-of-pack nutrition label on foods and beverages sold in a campus cafeteria in France on the nutritional quality of purchases.', 'detailedDescription': 'The introduction of front-of-package nutrition labelling is thought to help consumers making healthier food choices at the point-of-purchase.\n\nRecently, the French government has selected the Nutri-Score as single front-of-pack nutrition label.\n\nEvaluations of the Nutri-Score suggest it is in helping consumers making healthier choices. However, its impact in vulnerable populations has not yet been tested. Students are thought to be a vulnerable population due to their limited resources and to their unhealthy food choices.\n\nThe objective of the present study is to investigate the impact of the introduction of the Nutri-Score in campus cafeterias on the nutritional quality of food purchases. The intervention is conducted during several months, with a control period without front-of-pack nutrition labelling at the beginning of the university year.\n\nData on purchases is collected regularly through receipts, and the nutritional quality of purchases is evaluated over time between the intervention situation and the control situation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects purchasing foods or beverages in the selected campus cafeteria\n\nExclusion Criteria:\n\n* None No individual data is collected. Only purchases data is collected (cash register sales data)'}, 'identificationModule': {'nctId': 'NCT03336151', 'briefTitle': 'FOP Nutrition Label in Campus Cafeteria', 'organization': {'class': 'OTHER', 'fullName': 'University of Paris 13'}, 'officialTitle': 'Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus Cafeteria', 'orgStudyIdInfo': {'id': 'CROUS_NICE2C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Front-of-pack labelling Nutri-Score', 'description': 'Introduction of the Nutri-Score front-of-pack nutrition label on every food and beverage in the campus cafeteria after a control period without food labelling.\n\nThe implementation of the label is accompanied by a communication campaign towards students in the form of posters and leaflets.', 'interventionNames': ['Behavioral: Front-of-pack labelling Nutri-Score']}], 'interventions': [{'name': 'Front-of-pack labelling Nutri-Score', 'type': 'BEHAVIORAL', 'description': 'Introduction of the Nutri-Score front-of-pack nutrition label on shelf display tags for every food and beverage sold in the cafeteria', 'armGroupLabels': ['Front-of-pack labelling Nutri-Score']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nice', 'country': 'France', 'facility': 'CROUS Nice - Toulon', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Paris 13', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department', 'investigatorFullName': 'Serge HERCBERG', 'investigatorAffiliation': 'University of Paris 13'}}}}