Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-03 @ 1:38 AM
Study NCT ID:
NCT02804503
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2016-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Menu Labels on Calories Ordered in Hispanics
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 372}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-14', 'studyFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calories Ordered', 'timeFrame': '20-30 minutes', 'description': 'Calories content of the food items ordered from the assigned menu was calculated.'}], 'secondaryOutcomes': [{'measure': 'Macronutrients ordered', 'timeFrame': '20-30 minutes', 'description': 'Macronutrients content of the food items ordered from the assigned menu was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Food Selection']}, 'referencesModule': {'references': [{'pmid': '25790388', 'type': 'BACKGROUND', 'citation': 'Long MW, Tobias DK, Cradock AL, Batchelder H, Gortmaker SL. Systematic review and meta-analysis of the impact of restaurant menu calorie labeling. Am J Public Health. 2015 May;105(5):e11-24. doi: 10.2105/AJPH.2015.302570. Epub 2015 Mar 19.'}, {'pmid': '22152038', 'type': 'RESULT', 'citation': 'Swartz JJ, Braxton D, Viera AJ. Calorie menu labeling on quick-service restaurant menus: an updated systematic review of the literature. Int J Behav Nutr Phys Act. 2011 Dec 8;8:135. doi: 10.1186/1479-5868-8-135.'}, {'pmid': '25037558', 'type': 'RESULT', 'citation': 'Sinclair SE, Cooper M, Mansfield ED. The influence of menu labeling on calories selected or consumed: a systematic review and meta-analysis. J Acad Nutr Diet. 2014 Sep;114(9):1375-1388.e15. doi: 10.1016/j.jand.2014.05.014. Epub 2014 Jul 16.'}, {'pmid': '27402619', 'type': 'DERIVED', 'citation': 'Shah M, Bouza B, Adams-Huet B, Jaffery M, Esposito P, Dart L. Effect of calorie or exercise labels on menus on calories and macronutrients ordered and calories from specific foods in Hispanic participants: a randomized study. J Investig Med. 2016 Dec;64(8):1261-1268. doi: 10.1136/jim-2016-000227. Epub 2016 Jul 8.'}]}, 'descriptionModule': {'briefSummary': 'Most studies on menu labels have been conducted in mostly non-Hispanic white individuals, and how menu labels affect calories and macronutrients ordered in Hispanics is not clearly understood. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics.', 'detailedDescription': 'According to review studies, calorie labels on menus is not effective in reducing the number of calories ordered or consumed. Adding contextual information such as the energy needs per meal or interpretive information such as minutes of walking needed to burn the food calories or rank-ordering the food items from the lowest to the highest calorie content may be more effective in making food selections with fewer calories. Most studies on menu labels have, however, been conducted in mostly non-Hispanic white individuals, and how menu labels affect food choices in Hispanics in not well understood. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics by randomly assigning the participants to a menu with no labels (no labels), a menu with rank ordered calorie labels and a statement on the energy needs per meal (calorie labels), and a menu with rank ordered exercise labels (exercise labels). Calories and macronutrients ordered by the participants was assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hispanics ages 18 through 65 years.\n\nExclusion Criteria:\n\n* Not being able to read and write in either English or Spanish; pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT02804503', 'briefTitle': 'The Effect of Menu Labels on Calories Ordered in Hispanics', 'organization': {'class': 'OTHER', 'fullName': 'Texas Christian University'}, 'officialTitle': 'The Effect of Menu Labels on Food Choices in Hispanics', 'orgStudyIdInfo': {'id': 'CT2016MS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calorie Labels', 'description': 'A menu with rank ordered calorie labels and a statement on the energy needs per meal.', 'interventionNames': ['Behavioral: Calorie Labels']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise Labels', 'description': 'A menu with rank ordered exercise labels showing minutes of brisk walking necessary to burn the food calories.', 'interventionNames': ['Behavioral: Exercise Labels']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Labels', 'description': 'A menu with no labels', 'interventionNames': ['Behavioral: No Labels']}], 'interventions': [{'name': 'Calorie Labels', 'type': 'BEHAVIORAL', 'description': 'Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.', 'armGroupLabels': ['Calorie Labels']}, {'name': 'Exercise Labels', 'type': 'BEHAVIORAL', 'description': 'Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.', 'armGroupLabels': ['Exercise Labels']}, {'name': 'No Labels', 'type': 'BEHAVIORAL', 'description': 'Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.', 'armGroupLabels': ['No Labels']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76129', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Meena Shah', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Meena Shah, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tzu Chi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Christian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Meena Shah', 'investigatorAffiliation': 'Texas Christian University'}}}}