Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT02111694
Status:
COMPLETED
Last Update Posted:
2015-10-30
First Post:
2014-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Bottle-Type on Infant Feeding Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001903', 'term': 'Bottle Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2014-04-07', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant intake within a feeding (mL)', 'timeFrame': '3-hour period', 'description': 'assessed by weighing the bottle before and after a feeding'}, {'measure': 'Maternal responsiveness to infant cues during a feeding', 'timeFrame': '3-hour period', 'description': 'assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale'}], 'secondaryOutcomes': [{'measure': 'Maternal perception/acceptance of the bottles during a feeding', 'timeFrame': '3-hour period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infant', 'intake', 'satiation', 'mother', 'feeding practices', 'bottle feeding', 'formula feeding', 'maternal responsiveness', 'infant cues'], 'conditions': ['Conventional Clear Bottle', 'Opaque Weighted Bottle']}, 'referencesModule': {'references': [{'pmid': '25445988', 'type': 'RESULT', 'citation': 'Ventura AK, Pollack Golen R. A pilot study comparing opaque, weighted bottles with conventional, clear bottles for infant feeding. Appetite. 2015 Feb;85:178-84. doi: 10.1016/j.appet.2014.11.028. Epub 2014 Nov 28.'}, {'pmid': '25953601', 'type': 'DERIVED', 'citation': 'Golen RB, Ventura AK. Mindless feeding: Is maternal distraction during bottle-feeding associated with overfeeding? Appetite. 2015 Aug;91:385-92. doi: 10.1016/j.appet.2015.04.078. Epub 2015 May 4.'}]}, 'descriptionModule': {'briefSummary': "The objective of the proposed research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. The investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. The investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers must be 18 years or older\n* Infants must be between 0- and 6-months of age\n* Infants must be prior to the introduction of solid foods\n\nExclusion Criteria:\n\n* Preterm birth\n* Medical conditions that interfere with feeding'}, 'identificationModule': {'nctId': 'NCT02111694', 'acronym': 'OBS', 'briefTitle': 'Influence of Bottle-Type on Infant Feeding Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Drexel University'}, 'officialTitle': 'Influence of Bottle-Type on Infant Feeding Behaviors', 'orgStudyIdInfo': {'id': 'OBS-1303001967'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clear versus Opaque Bottle', 'description': 'This is a within-subject study; all infants will be exposed to both conditions. Order of presentation will be counterbalanced across infants.', 'interventionNames': ['Behavioral: Bottle Type']}], 'interventions': [{'name': 'Bottle Type', 'type': 'BEHAVIORAL', 'description': 'Infants will be fed from a conventional, clear bottle during one feeding and from an opaque, weighted bottle from another feeding', 'armGroupLabels': ['Clear versus Opaque Bottle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Alison K Ventura, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drexel University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drexel University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}