Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-01-25 @ 12:54 AM
Study NCT ID:
NCT03643250
Status:
TERMINATED
Last Update Posted:
2019-04-22
First Post:
2018-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Varying Portion Size and Palatability on Food Intake of Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'We observed reduced intake by the fifth week, so we are shortening the study and simplifying it by using a complete factorial design with four conditions.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Liking of food served at the meal', 'timeFrame': 'Study week 6', 'description': 'The Yummy-Yucky Cartoon Faces Scale (1=Yucky, 2=Just Okay, and 3=Yummy)'}, {'measure': 'Preference of plate and vegetables served at the meal', 'timeFrame': 'Study week 6', 'description': 'Preferred version of plate (1=non-divided plate, 2=divided plate), broccoli (1=standard appeal, 2=enhanced appeal), and corn (1=standard appeal, 2=enhanced appeal) of the two versions presented'}], 'primaryOutcomes': [{'measure': 'Difference between interventions in meal energy intake', 'timeFrame': 'Study weeks 1, 2, 3, 4, and 5', 'description': 'Energy consumed at the meal (kcal)'}], 'secondaryOutcomes': [{'measure': 'Difference between interventions in food intake', 'timeFrame': 'Study weeks 1, 2, 3, 4, and 5', 'description': 'Weight of food consumed at the meal (g)'}, {'measure': 'Difference between interventions in meal energy density', 'timeFrame': 'Study weeks 1, 2, 3, 4, and 5', 'description': 'Energy density of the food consumed at the meal (kcal/g)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Feeding Behavior']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the effect of varying both the portion size and the appeal (palatability and presentation) of foods served to preschool children at a meal on the outcomes of food and energy intake at the meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children who are enrolled in a scheduled classroom of the designated childcare centers\n\nExclusion Criteria:\n\n* Children who are allergic to any of the foods served\n* Children whose diets exclude any of the foods served\n* Children who will not be present at the childcare center for all of the scheduled study days'}, 'identificationModule': {'nctId': 'NCT03643250', 'briefTitle': 'Effects of Varying Portion Size and Palatability on Food Intake of Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Lunch Feeding Study for Preschool Children', 'orgStudyIdInfo': {'id': 'ChildFood401'}, 'secondaryIdInfos': [{'id': 'R01DK082580', 'link': 'https://reporter.nih.gov/quickSearch/R01DK082580', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smaller Portion Size and Standard Appeal (non-divided plate)', 'description': 'Food with Smaller Portion Size and Standard Appeal on a non-divided plate', 'interventionNames': ['Other: Smaller Portion Size and Standard Appeal (non-divided plate)']}, {'type': 'EXPERIMENTAL', 'label': 'Smaller Portion Size and Enhanced Appeal (divided plate)', 'description': 'Food with Smaller Portion Size and Enhanced Appeal on a divided plate', 'interventionNames': ['Other: Smaller Portion Size and Enhanced Appeal (divided plate)']}, {'type': 'EXPERIMENTAL', 'label': 'Larger Portion Size and Standard Appeal (non-divided plate)', 'description': 'Food with Larger Portion Size and Standard Appeal on a non-divided plate', 'interventionNames': ['Other: Larger Portion Size and Standard Appeal (non-divided plate)']}, {'type': 'EXPERIMENTAL', 'label': 'Larger Portion Size and Enhanced Appeal (divided plate)', 'description': 'Food with Larger Portion Size and Enhanced Appeal on a divided plate', 'interventionNames': ['Other: Larger Portion Size and Enhanced Appeal (divided plate)']}, {'type': 'EXPERIMENTAL', 'label': 'Smaller Portion Size and Standard Appeal (divided plate)', 'description': 'Food with Smaller Portion Size and Standard Appeal on a divided plate', 'interventionNames': ['Other: Smaller Portion Size and Standard Appeal (divided plate)']}], 'interventions': [{'name': 'Smaller Portion Size and Standard Appeal (non-divided plate)', 'type': 'OTHER', 'description': 'Food with Smaller Portion Size and Standard Appeal on a non-divided plate', 'armGroupLabels': ['Smaller Portion Size and Standard Appeal (non-divided plate)']}, {'name': 'Smaller Portion Size and Enhanced Appeal (divided plate)', 'type': 'OTHER', 'description': 'Food with Smaller Portion Size and Enhanced Appeal on a divided plate', 'armGroupLabels': ['Smaller Portion Size and Enhanced Appeal (divided plate)']}, {'name': 'Larger Portion Size and Standard Appeal (non-divided plate)', 'type': 'OTHER', 'description': 'Food with Larger Portion Size and Standard Appeal on a non-divided plate', 'armGroupLabels': ['Larger Portion Size and Standard Appeal (non-divided plate)']}, {'name': 'Larger Portion Size and Enhanced Appeal (divided plate)', 'type': 'OTHER', 'description': 'Food with Larger Portion Size and Enhanced Appeal on a divided plate', 'armGroupLabels': ['Larger Portion Size and Enhanced Appeal (divided plate)']}, {'name': 'Smaller Portion Size and Standard Appeal (divided plate)', 'type': 'OTHER', 'description': 'Food with Smaller Portion Size and Standard Appeal on a divided plate', 'armGroupLabels': ['Smaller Portion Size and Standard Appeal (divided plate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition and Director of the Laboratory for the Study Human Ingestive Behavior', 'investigatorFullName': 'Barbara J. Rolls', 'investigatorAffiliation': 'Penn State University'}}}}