Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT00127660
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2005-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Nutrition Labeling on Fast Food Choices
Sponsor:
Organization:
Raw JSON
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'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Menu: Calories=Yes, Value Pricing=no', 'description': 'Calories listed on menu, but value pricing was not in place.'}, {'id': 'OG001', 'title': 'Menu: Calories=Yes, Value Pricing = Yes', 'description': 'Calories listed on menu, value pricing in place.'}, {'id': 'OG002', 'title': 'Menu: Calories=no, Value Pricing = no', 'description': 'Calories not listed on menu, value pricing not in place'}, {'id': 'OG003', 'title': 'Menu: Calories=no, Value Pricing = Yes', 'description': 'CONTROL CONDITION: calories not listed on menu, value pricing in place.'}], 'classes': [{'categories': [{'measurements': [{'value': '842.3', 'spread': '425.3', 'groupId': 'OG000'}, {'value': '873.6', 'spread': '439.1', 'groupId': 'OG001'}, {'value': '881.7', 'spread': '353.6', 'groupId': 'OG002'}, {'value': '827.5', 'spread': '400.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After meal', 'description': 'energy content of meal ordered and consumed.', 'unitOfMeasure': 'kcal/meal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Menu: Calories=Yes, Value Pricing=no', 'description': 'Calories listed on menu, but value pricing was not in place.'}, {'id': 'FG001', 'title': 'Menu: Calories=Yes, Value Pricing = Yes', 'description': 'Calories listed on menu, value pricing in place.'}, {'id': 'FG002', 'title': 'Menu: Calories=no, Value Pricing = no', 'description': 'Calories not listed on menu, value pricing not in place'}, {'id': 'FG003', 'title': 'Menu: Calories=no, Value Pricing = Yes', 'description': 'CONTROL CONDITION: calories not listed on menu, value pricing in place.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '148'}, {'groupId': 'FG003', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '151'}, {'groupId': 'FG002', 'numSubjects': '143'}, {'groupId': 'FG003', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '594', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Menu: Calories=Yes, Value Pricing=no', 'description': 'Calories listed on menu, but value pricing was not in place.'}, {'id': 'BG001', 'title': 'Menu: Calories=Yes, Value Pricing = Yes', 'description': 'Calories listed on menu, value pricing in place.'}, {'id': 'BG002', 'title': 'Menu: Calories=no, Value Pricing = no', 'description': 'Calories not listed on menu, value pricing not in place'}, {'id': 'BG003', 'title': 'Menu: Calories=no, Value Pricing = Yes', 'description': 'CONTROL CONDITION: calories not listed on menu, value pricing in place.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '147', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}, {'value': '363', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '353', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '241', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}, {'value': '594', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 605}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-30', 'studyFirstSubmitDate': '2005-08-04', 'resultsFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2005-08-05', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-25', 'studyFirstPostDateStruct': {'date': '2005-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Calories of Meal Ordered', 'timeFrame': 'single study visit'}, {'measure': 'Energy Intake', 'timeFrame': 'After meal', 'description': 'energy content of meal ordered and consumed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Behavior'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '19061510', 'type': 'RESULT', 'citation': 'Harnack LJ, French SA, Oakes JM, Story MT, Jeffery RW, Rydell SA. Effects of calorie labeling and value size pricing on fast food meal choices: results from an experimental trial. Int J Behav Nutr Phys Act. 2008 Dec 5;5:63. doi: 10.1186/1479-5868-5-63.'}, {'pmid': '19928485', 'type': 'RESULT', 'citation': 'Fitch RC, Harnack LJ, Neumark-Sztainer DR, Story MT, French SA, Oakes JM, Rydell SA. Providing calorie information on fast-food restaurant menu boards: consumer views. Am J Health Promot. 2009 Nov-Dec;24(2):129-32. doi: 10.4278/ajhp.08031426.'}, {'pmid': '19027410', 'type': 'RESULT', 'citation': 'Rydell SA, Harnack LJ, Oakes JM, Story M, Jeffery RW, French SA. Why eat at fast-food restaurants: reported reasons among frequent consumers. J Am Diet Assoc. 2008 Dec;108(12):2066-70. doi: 10.1016/j.jada.2008.09.008.'}]}, 'descriptionModule': {'briefSummary': 'A study examining menu choices made at fast food restaurants.', 'detailedDescription': 'To examine the effect of point-of-purchase calorie information and value size pricing on fast food meal choices a randomized 2 × 2 factorial experiment was conducted in which participants ordered a fast food meal from one of four menus that varied with respect to whether calorie information was provided and whether value size pricing was used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 16 years old or older\n* Must regularly eat at fast food restaurants\n\nExclusion Criteria:\n\n* Non-english speakers'}, 'identificationModule': {'nctId': 'NCT00127660', 'briefTitle': 'Effect of Nutrition Labeling on Fast Food Choices', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Effect of Nutrition Labeling on Fast Food Choices', 'orgStudyIdInfo': {'id': 'DK67599 (completed)'}, 'secondaryIdInfos': [{'id': 'R01DK067599', 'link': 'https://reporter.nih.gov/quickSearch/R01DK067599', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menu: calories=yes, value pricing=no', 'description': 'There were calories listed on the menu, but no value pricing was in place.', 'interventionNames': ['Behavioral: Menu: calories=yes, value pricing=no']}, {'type': 'EXPERIMENTAL', 'label': 'Menu: calories=yes, value pricing = yes', 'description': 'There were calories listed on the menu, AND value pricing was in place.', 'interventionNames': ['Behavioral: Menu: calories=yes, value pricing = yes']}, {'type': 'EXPERIMENTAL', 'label': 'Menu: calories=no, value pricing = no', 'description': 'Calories were not listed on the menu, and value pricing was not in place.', 'interventionNames': ['Behavioral: Menu: calories=no, value pricing = no']}, {'type': 'NO_INTERVENTION', 'label': 'Menu: calories=no, value pricing = yes', 'description': 'CONTROL CONDITION: calories were not listed on the menu, and value pricing WAS in place.'}], 'interventions': [{'name': 'Menu: calories=yes, value pricing=no', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Menu: calories=yes, value pricing=no']}, {'name': 'Menu: calories=yes, value pricing = yes', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Menu: calories=yes, value pricing = yes']}, {'name': 'Menu: calories=no, value pricing = no', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Menu: calories=no, value pricing = no']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Division of Epidemiology & Community Health, University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Lisa J Harnack, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}