Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-21 @ 1:35 PM
Study NCT ID:
NCT03072251
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2017-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Participation of Breast Milk Feeding Mothers in Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 570}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prevalence of breastfeeding in the survey population (exclusive, in combination with infant formula, in combination with other foods)', 'timeFrame': '1 day', 'description': 'Outcome measured by questionnaire'}, {'measure': 'Method of feeding (breast, expressed human milk in an infant feeding bottle, combination of feeding methods)', 'timeFrame': '1 day', 'description': 'Outcome measured by questionnaire'}], 'primaryOutcomes': [{'measure': 'Receptivity for measuring milk intake for 5-7 days using a smartphone app', 'timeFrame': '1 day', 'description': 'Outcome measured by questionnaire'}], 'secondaryOutcomes': [{'measure': 'Receptivity for expressing human breast milk to assess milk intake for 5-7 days', 'timeFrame': '1 day', 'description': 'Outcome measured by questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breastfeeding', 'Energy Intake', 'eHealth']}, 'descriptionModule': {'briefSummary': 'To assess concerns and barriers for measuring milk intake of breast fed infants using the remote food photography method and SmartIntake smartphone application. These data will 1) provide support for further development of the Infant RFPM and 2) provide important preliminary data in a National Institutes of Health grant application being developed and assess the prevalence of exclusive breastfeeding and complementary breastfeeding in the study population.', 'detailedDescription': 'Study participation will be the completion of an anonymous, online survey powered by HIPAA compliant REDCap database. The survey will be made available to potential participants through the internet. The survey will take approximately five minutes to complete. The expected duration of recruitment and completion of the study is six months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited from the community via print, electronic, and social media. Any individual may take the survey.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any individual may take the survey.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03072251', 'briefTitle': 'Participation of Breast Milk Feeding Mothers in Research', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Participation of Breast Milk Feeding Mothers in Research', 'orgStudyIdInfo': {'id': 'PBRC 2017-006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anyone', 'description': 'Any individual may complete this survey'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Leanne Redman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Leanne Redman', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}