Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-28 @ 2:12 PM
Study NCT ID:
NCT04340804
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2020-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of kcal and PACE Labelling on Self-served Portion Size
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005518', 'term': 'Food Preferences'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-07', 'size': 1526173, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-04-07T11:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total self-served energy (kcal)', 'timeFrame': '10 minutes (the time frame denotes time taken to perform the portion selection task and there is no follow up)', 'description': 'Energy content of the portion selected for each dish.'}], 'secondaryOutcomes': [{'measure': 'Kcal influence', 'timeFrame': '3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)', 'description': 'Whether kcal content influences the quantity of self-served food'}, {'measure': 'PACE influence', 'timeFrame': '3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)', 'description': 'Whether physical activity energy equivalent influences the quantity of self-served food.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['kcal labelling', 'PACE labelling', 'portion size', 'socio-economic position'], 'conditions': ['Diet, Healthy', 'Food Selection']}, 'referencesModule': {'availIpds': [{'url': 'https://osf.io/k369t/', 'type': 'Study Protocol'}, {'url': 'https://osf.io/k369t/', 'type': 'Statistical Analysis Plan'}, {'url': 'https://osf.io/k369t/', 'type': 'Informed Consent Form'}, {'url': 'https://osf.io/k369t/', 'type': 'Individual Participant Data Set', 'comment': 'When results will be published'}]}, 'descriptionModule': {'briefSummary': 'Participants will take part in an online survey. They will be asked to choose the amount of food they would like to eat based on pictures of 18 dishes sequentially displayed on the screen. They will be randomly allocated to four different groups: kcal labelling, PACE labelling (Physical Activity Calorie Equivalent: minutes to walk to burn off the calories), kcal and PACE labelling combined, no labelling, in a between subject design. The main outcome variable is the total "self-served" energy for each dish (in kcal).', 'detailedDescription': 'See attached protocol documents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* United Kingdom residents\n* Age ≥ 18\n* Fluent in English\n* Have access to a computer and Internet\n\nExclusion Criteria:\n\n* Have any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, diary or lactose free, food allergy)'}, 'identificationModule': {'nctId': 'NCT04340804', 'briefTitle': 'Effect of kcal and PACE Labelling on Self-served Portion Size', 'organization': {'class': 'OTHER', 'fullName': 'University of Liverpool'}, 'officialTitle': 'Socioeconomic Position and the Effect of kcal Labelling and PACE Labelling on Self-served Portion Size', 'orgStudyIdInfo': {'id': '803194 1B4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kcal labelling', 'description': 'Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time kcal counter synchronised with the food amount changes (i.e., increasing/decreasing).', 'interventionNames': ['Behavioral: Kcal labelling']}, {'type': 'EXPERIMENTAL', 'label': 'PACE labelling', 'description': 'Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes (i.e., increasing/decreasing) with 4 min being equivalent to 20 kcal.', 'interventionNames': ['Behavioral: PACE labelling']}, {'type': 'EXPERIMENTAL', 'label': 'Kcal and PACE labelling', 'description': 'Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time kcal and PACE counters synchronised to the food amount changes (i.e., increasing/decreasing).', 'interventionNames': ['Behavioral: Kcal labelling', 'Behavioral: PACE labelling']}, {'type': 'NO_INTERVENTION', 'label': 'No labelling', 'description': 'Participants allocated to this group will only see on the screen the amount of food increasing or decreasing based how many times they tap on the corresponding keys.'}], 'interventions': [{'name': 'Kcal labelling', 'type': 'BEHAVIORAL', 'description': 'Real-time kcal counter synchronised with the food amount changes', 'armGroupLabels': ['Kcal and PACE labelling', 'Kcal labelling']}, {'name': 'PACE labelling', 'type': 'BEHAVIORAL', 'description': 'Real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes', 'armGroupLabels': ['Kcal and PACE labelling', 'PACE labelling']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L69 7ZA', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'University of Liverpool', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}]}, 'ipdSharingStatementModule': {'url': 'https://osf.io/k369t/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'On publication, indefinitely', 'ipdSharing': 'YES', 'description': 'Shared on the Open Science Framework', 'accessCriteria': 'Open website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liverpool', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric Robinson', 'investigatorAffiliation': 'University of Liverpool'}}}}