Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05623618
Status:
UNKNOWN
Last Update Posted:
2022-11-21
First Post:
2022-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Understanding the Impact of Physical Activity Calorie Equivalent (PACE) Labelling in Secondary Schools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-18', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of daily purchases/units sold of the specified discretionary food(s) in secondary school canteens.', 'timeFrame': 'Baseline period (a minimum of 4 weeks), Intervention period (up to 6 weeks) and Washout period (up to 6 weeks, and if time allows)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eating Behaviour of Discretionary Foods']}, 'referencesModule': {'references': [{'pmid': '40011948', 'type': 'DERIVED', 'citation': 'Iris N, Munir F, Daley AJ. Physical activity calorie equivalent (PACE) food labelling on discretionary foods in secondary school canteens in England: an efficacy cluster randomised controlled trial. Int J Behav Nutr Phys Act. 2025 Feb 26;22(1):24. doi: 10.1186/s12966-025-01710-1.'}]}, 'descriptionModule': {'briefSummary': "The aim is to undertake a cluster randomised controlled trial to assess the effectiveness of PACE food labelling in reducing young people's purchasing of discretionary foods in secondary school canteens. Physical activity calorie equivalent (PACE) food labelling aims to show the number of minutes or miles/kilometres of physical activity equivalent to the calories contained in food/drinks.", 'detailedDescription': "Physical activity calorie equivalent (PACE) food labelling aims to show the number of minutes or miles/kilometres of physical activity equivalent to the calories contained in food/drinks. Evidence suggests that PACE food labelling may influence food/drink choice. Most research in this area however have tested PACE food labels with adults and/or have tested hypothetical food choice scenarios. Studies in real world contexts with young people are needed to see if PACE food labels could help them make healthier food choices.\n\nThe aim is to assess the effectiveness of PACE food labelling in reducing young people's purchasing of discretionary foods in secondary school canteens. A cluster randomised controlled trial with a nested qualitative study will be conducted. Secondary schools will be randomised to either display PACE labelling near discretionary foods or continue with their usual practice. The intervention period will be up to 6 weeks. Anonymised purchase data will be collected throughout the study period.\n\nQualitative interviews will be conducted with students in the intervention schools to explore their views of the PACE labels such as perceived influence of the PACE labelling on their food selection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Secondary schools:\n\nInclusion Criteria:\n\n* Secondary schools that admit young people aged between 10 to 19 years.\n* Sell at least one type of cake and/or at least one type of sweet biscuit for at least 2 days per week up to a 6 week period (or equivalent), and have sold the same cake(s)/biscuit(s) before the study (for a minimum of 4 weeks).\n* Able to provide to the researcher with anonymised purchase data for study periods. Data to include number of units sold and dates sold of the chosen food item(s).\n* A PACE label could feasibly be placed near to the study elected food item(s) in a school canteen used by students.\n* Not participating in any other school trials or initiatives.\n\nExclusion Criteria:\n\n* Secondary schools not meeting the inclusion criteria.\n* Secondary schools that admit young people below the age of 10 years or above the age of 19 years.'}, 'identificationModule': {'nctId': 'NCT05623618', 'briefTitle': 'Understanding the Impact of Physical Activity Calorie Equivalent (PACE) Labelling in Secondary Schools', 'organization': {'class': 'OTHER', 'fullName': 'Loughborough University'}, 'officialTitle': 'A Cluster Randomised Controlled Trial Testing Physical Activity Calorie Equivalent (PACE) Labelling on Discretionary Foods in Secondary Schools', 'orgStudyIdInfo': {'id': '7011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (PACE labelling)', 'description': 'PACE labelling implemented near at least one discretionary food item in secondary school canteens for up to 6 weeks.', 'interventionNames': ['Behavioral: PACE labelling']}, {'type': 'NO_INTERVENTION', 'label': 'Control (usual practice)', 'description': 'PACE labelling not implemented. Secondary schools continue with their usual practice.'}], 'interventions': [{'name': 'PACE labelling', 'type': 'BEHAVIORAL', 'description': 'PACE labelling implemented near at least one discretionary food item in secondary school canteens for up to 6 weeks.', 'armGroupLabels': ['Intervention (PACE labelling)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Loughborough', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Natalia Iris', 'role': 'CONTACT', 'email': 'n.iris@lboro.ac.uk'}], 'facility': 'Loughborough University', 'geoPoint': {'lat': 52.76667, 'lon': -1.2}}], 'centralContacts': [{'name': 'Natalia Iris', 'role': 'CONTACT', 'email': 'n.iris@lboro.ac.uk', 'phone': '+44 (0)1509 226372'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loughborough University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Natalia Iris', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Amanda Daley', 'investigatorAffiliation': 'Loughborough University'}}}}