Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-30 @ 4:32 PM
Study NCT ID:
NCT01252433
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2010-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children's Intake of Foods Reduced in Energy Density
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-15', 'studyFirstSubmitDate': '2010-12-02', 'studyFirstSubmitQcDate': '2010-12-02', 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Food intake', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Energy intake', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vegetable Intake']}, 'referencesModule': {'references': [{'pmid': '21775554', 'type': 'DERIVED', 'citation': "Spill MK, Birch LL, Roe LS, Rolls BJ. Hiding vegetables to reduce energy density: an effective strategy to increase children's vegetable intake and reduce energy intake. Am J Clin Nutr. 2011 Sep;94(3):735-41. doi: 10.3945/ajcn.111.015206. Epub 2011 Jul 20."}]}, 'descriptionModule': {'briefSummary': "The purpose of this research is to investigate children's responses to incorporating vegetables into selected entrees and snacks over several days. The hypothesis is that children will increase their vegetable intake by consuming foods that have been reduced in energy density through the addition of vegetables. Effects on energy intake will also be examined."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* enrolled in daycare centers at Penn State University\n\nExclusion Criteria:\n\n* food allergies or intolerances'}, 'identificationModule': {'nctId': 'NCT01252433', 'briefTitle': "Children's Intake of Foods Reduced in Energy Density", 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': "Children's Intake of Foods Reduced in Energy Density", 'orgStudyIdInfo': {'id': 'FoodED201'}, 'secondaryIdInfos': [{'id': 'R01DK082580', 'link': 'https://reporter.nih.gov/quickSearch/R01DK082580', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Entree energy density 100%', 'description': '100% energy density', 'interventionNames': ['Other: Energy density feeding study']}, {'type': 'EXPERIMENTAL', 'label': 'Entree energy density 85%', 'description': '85% energy density', 'interventionNames': ['Other: Energy density feeding study']}, {'type': 'EXPERIMENTAL', 'label': 'Entree energy density 75%', 'description': '75% energy density', 'interventionNames': ['Other: Energy density feeding study']}], 'interventions': [{'name': 'Energy density feeding study', 'type': 'OTHER', 'description': 'In a crossover study, children are served all foods 1 day a week for 3 weeks. Meal entrees will vary in energy density (100%, 85%, 75%).', 'armGroupLabels': ['Entree energy density 100%', 'Entree energy density 75%', 'Entree energy density 85%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Pennsylvania State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}]}, '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 of Human Ingestive Behavior', 'investigatorFullName': 'Barbara J. Rolls', 'investigatorAffiliation': 'Penn State University'}}}}