Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-03-19 @ 9:02 AM
Study NCT ID:
NCT02755558
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Energy Density and Portion Size of Milk in 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2016-04-22', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between experimental conditions for milk, food, and total intake by weight', 'timeFrame': 'once a week for 4 weeks', 'description': 'Difference between experimental conditions in milk intake (weight in grams), food intake (weight in grams), total meal intake (weight in grams)'}, {'measure': 'Difference between experiential conditions for milk, food, and total intake by energy', 'timeFrame': 'once a week for 4 weeks', 'description': 'Difference between experimental conditions for milk intake (energy in kcal), food intake (energy in kcal), and total meal energy intake (energy in kcal)'}], 'secondaryOutcomes': [{'measure': 'Meal energy density', 'timeFrame': 'once a week for 4 weeks', 'description': 'Meal energy density (energy density in kcal/g)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Feeding Behaviors']}, 'descriptionModule': {'briefSummary': "In this study, the investigators varied both the energy density and portion size of milk served with a meal commonly consumed by preschool children. The milk used in this study is commercially available and reflects typical variations in energy density. The primary aim of the study is to investigate the independent and combined effects of milk energy density and portion size on preschool children's intake of the milk and the simultaneously served meal. The effect of milk energy density and portion size on children's total energy intake at the meal will also be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children must be enrolled in participating childcare centers\n\nExclusion Criteria:\n\n* Allergy or intolerance to any of the foods or beverages served'}, 'identificationModule': {'nctId': 'NCT02755558', 'briefTitle': 'Effects of Energy Density and Portion Size of Milk in Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Effects of Energy Density and Portion Size of Milk in Preschool Children', 'orgStudyIdInfo': {'id': 'ChildFood301'}, 'secondaryIdInfos': [{'id': 'R01DK082580', 'link': 'https://reporter.nih.gov/quickSearch/R01DK082580', 'type': 'NIH'}, {'id': '2011-67001-30117', 'type': 'OTHER_GRANT', 'domain': 'The Pennsylvania State University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low energy density, small portion', 'description': 'Low milk energy density and small portion size', 'interventionNames': ['Behavioral: Low energy density', 'Behavioral: Small portion']}, {'type': 'EXPERIMENTAL', 'label': 'Low energy density, large portion', 'description': 'Low milk energy density and large portion size', 'interventionNames': ['Behavioral: Low energy density', 'Behavioral: Large portion']}, {'type': 'EXPERIMENTAL', 'label': 'High energy density, small portion', 'description': 'High milk energy density and small portion size', 'interventionNames': ['Behavioral: High energy density', 'Behavioral: Small portion']}, {'type': 'EXPERIMENTAL', 'label': 'High energy density, large portion', 'description': 'High milk energy density and large portion size', 'interventionNames': ['Behavioral: High energy density', 'Behavioral: Large portion']}], 'interventions': [{'name': 'Low energy density', 'type': 'BEHAVIORAL', 'description': 'Low energy density milk served', 'armGroupLabels': ['Low energy density, large portion', 'Low energy density, small portion']}, {'name': 'High energy density', 'type': 'BEHAVIORAL', 'description': 'High energy density milk served', 'armGroupLabels': ['High energy density, large portion', 'High energy density, small portion']}, {'name': 'Small portion', 'type': 'BEHAVIORAL', 'description': 'Small portion of milk served', 'armGroupLabels': ['High energy density, small portion', 'Low energy density, small portion']}, {'name': 'Large portion', 'type': 'BEHAVIORAL', 'description': 'Large portion of milk served', 'armGroupLabels': ['High energy density, large portion', 'Low energy density, large portion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}], 'overallOfficials': [{'name': 'Barbara J Rolls', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Pennsylvania State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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 Nutritional Sciences', 'investigatorFullName': 'Barbara J. Rolls', 'investigatorAffiliation': 'Penn State University'}}}}