Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-01 @ 5:40 PM
Study NCT ID:
NCT03283033
Status:
TERMINATED
Last Update Posted:
2023-11-24
First Post:
2017-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
School Lunch Salad Bars and Fruit and Vegetable Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005518', 'term': 'Food Preferences'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D040541', 'term': 'Marketing'}], 'ancestors': [{'id': 'D003132', 'term': 'Commerce'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7491}}, 'statusModule': {'whyStopped': 'COVID-19 closed schools in March 2020. Data collection for all elementary schools was completed pre-pandemic. For middle and high schools, the marketing phase was halted. Results will solely reflect the salad bar intervention.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in grams of fruit and vegetables consumed', 'timeFrame': 'Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)', 'description': 'The amount (grams) of fresh and canned fruits and vegetables consumed at lunch'}], 'secondaryOutcomes': [{'measure': 'Change in grams of fruit and vegetables selected', 'timeFrame': 'Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)', 'description': 'The amount (grams) of fresh and canned fruits and vegetables selected at lunch'}, {'measure': 'Change in percent of fruit and vegetables wasted', 'timeFrame': 'Baseline (prior to randomization allocation of installation of salad bars), Time 2 (6 weeks after randomization), and Time 3 (10 weeks after randomization)', 'description': 'The percent of fresh and canned fruits and vegetables wasted at lunch'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'Plate Waste', 'Fruit and vegetable intake', 'School lunch', 'social marketing'], 'conditions': ['Children, Only', 'Behavior, Eating', 'School', 'Obesity', 'Food Selection', 'Food Habits', 'Diet Modification', 'Adolescent Behavior']}, 'referencesModule': {'references': [{'pmid': '30572161', 'type': 'BACKGROUND', 'citation': "Adams MA, Ohri-Vachaspati P, Richards TJ, Todd M, Bruening M. Design and rationale for evaluating salad bars and students' fruit and vegetable consumption: A cluster randomized factorial trial with objective assessments. Contemp Clin Trials. 2019 Feb;77:37-45. doi: 10.1016/j.cct.2018.12.007. Epub 2018 Dec 18."}, {'pmid': '29214812', 'type': 'RESULT', 'citation': 'Bruening M, Adams MA, Ohri-Vachaspati P, Hurley J. Prevalence and Implementation Practices of School Salad Bars Across Grade Levels. Am J Health Promot. 2018 Jul;32(6):1375-1382. doi: 10.1177/0890117116689159. Epub 2017 Feb 19.'}, {'pmid': '40420203', 'type': 'DERIVED', 'citation': "Adams MA, Todd M, McEntee ML, Yu TY, Ohri-Vachaspati P, Richards TJ, Bruening M. A cluster randomized factorial trial of school-lunch salad bars and marketing on elementary students' objectively measured fruit and vegetable consumption. Int J Behav Nutr Phys Act. 2025 May 26;22(1):58. doi: 10.1186/s12966-025-01758-z."}]}, 'descriptionModule': {'briefSummary': "The investigators propose an efficacy study (i.e., do salad bars work under controlled conditions in naturalistic settings) to test whether introducing salad bars in elementary, middle, and high schools that have never had salad bars affects students' FV consumption and waste during lunch. A cluster randomized controlled trial will test new salad bars against controls for 6 wks, with/without an additional 4-wk marketing phase ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students enrolled in any grade between grades one and twelve\n* Student ID number matches that on a list of randomly selected student ID numbers from the population of student enrolled in school\n* Students who elect to receive a hot entree at lunch\n* Students who assent to participate\n\nExclusion Criteria:\n\n* Students in detention\n* Students in special education\n* Students in Kindergarten\n* Students not in school for any reason (e.g. illness, vacation)'}, 'identificationModule': {'nctId': 'NCT03283033', 'briefTitle': 'School Lunch Salad Bars and Fruit and Vegetable Consumption', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': "Salad Bars and Students' Fruit and Vegetable Consumption: A Group-randomized Trial With Objective Assessments", 'orgStudyIdInfo': {'id': 'R01HL139120', 'link': 'https://reporter.nih.gov/quickSearch/R01HL139120', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental 3', 'description': 'Introduction of a new salad bar and marketing conditions during second semester of school year', 'interventionNames': ['Behavioral: New salad bar', 'Behavioral: Marketing']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 2', 'description': 'Introduction of marketing conditions during second semester of school year', 'interventionNames': ['Behavioral: Marketing']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 1', 'description': 'Introduction of a new salad bar during second semester of school year', 'interventionNames': ['Behavioral: New salad bar']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No introduction of a new salad bar and no introduction of marketing conditions'}], 'interventions': [{'name': 'New salad bar', 'type': 'BEHAVIORAL', 'description': 'New salad bar placed in school', 'armGroupLabels': ['Experimental 1', 'Experimental 3']}, {'name': 'Marketing', 'type': 'BEHAVIORAL', 'description': 'Marketing conditions (printed material, displays, verbal announcements, prompts and taste tests)', 'armGroupLabels': ['Experimental 2', 'Experimental 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona State University', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Marc Adams, PhD, MPH', 'investigatorAffiliation': 'Arizona State University'}}}}