Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT05767658
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2023-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Support Via Online Social Networks to Promote Safe Infant Care Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D066088', 'term': 'Infant Death'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007774', 'term': 'Lactation'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D049590', 'term': 'Postpartum Period'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2023-03-02', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant sleep position in the previous two weeks', 'timeFrame': 'Between 2 and 6 months', 'description': "An investigator-developed maternal survey will be used to assess infant's usual sleep position during the previous two weeks with categorical responses of back, stomach, side, and other."}, {'measure': 'Infant sleep location in the previous two weeks', 'timeFrame': 'Between 2 and 6 months', 'description': "An investigator-developed maternal survey will be used to assess the infant's usual sleep location during the previous two weeks with categorical responses of room sharing without bed sharing, room sharing with bed sharing, no room sharing and no bed sharing."}, {'measure': 'Soft bedding use in the previous two weeks', 'timeFrame': 'Between 2 and 6 months', 'description': 'An investigator-developed maternal survey will be used to assess soft bedding placed in and around the infant (while sleeping) during the previous two weeks with categorical responses of Yes or No.'}, {'measure': 'Pacifier use in the previous two weeks', 'timeFrame': 'Between 2 and 6 months', 'description': "An investigator-developed maternal survey will be used to assess the infant's pacifier use during the previous two weeks with categorical responses of Yes or No."}, {'measure': 'Breastmilk feeding in the previous two weeks', 'timeFrame': 'Between 2 and 6 months', 'description': 'An investigator-developed maternal survey will be used to assess whether the infant was breast fed during the previous two weeks with categorical responses of exclusively breast fed, partially breast fed, or not breast fed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safe Sleep', 'Breastfeeding', 'Social Media'], 'conditions': ['Breastfeeding', 'Infant Death', 'Sudden Infant Death Syndrome Without Mention of Autopsy']}, 'descriptionModule': {'briefSummary': 'This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF); and reduce Black/White disparities in these practices through the use of private Facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant WIC clients and new parents.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently enrolled in WIC, or it not, then have either Medicaid or no health insurance\n* Must be English speaking\n* Must be pregnant and less than 30 weeks gestation\n* Must live in the United States\n* Must have regular access to Facebook and short message service (SMS) texting (mobile phone)\n\nExclusion Criteria:\n\n* Not planning to live in same home as infant after birth.\n* Prenatal diagnosis expected to impact on infant care practices in a manner not compatible with study goals, including contraindications to feeding any breastmilk or supine infant sleep positioning.\n* Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process.\n* Meets the definition of a minor according to applicable state law.\n* Participants who consent to participation in the study, must complete the Agile Onboarding process before they reach 30+0 weeks gestation.\n* Currently or previously received a TodaysBaby educational program (randomized to a TodaysBaby program through either the SMARTER, or SUPERSONIC study), either in their current or a previous pregnancy.'}, 'identificationModule': {'nctId': 'NCT05767658', 'acronym': 'SUPERSONIC', 'briefTitle': 'Support Via Online Social Networks to Promote Safe Infant Care Practices', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality', 'orgStudyIdInfo': {'id': 'H-43455'}, 'secondaryIdInfos': [{'id': '5R01MD007702-07', 'link': 'https://reporter.nih.gov/quickSearch/5R01MD007702-07', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safe Sleep', 'description': 'Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and b) an online community and social network of other pregnant WIC clients and new parents', 'interventionNames': ['Behavioral: Safe Sleep']}, {'type': 'EXPERIMENTAL', 'label': 'Breastfeeding', 'description': 'Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for breastfeeding and b) an online community and social network of other pregnant WIC clients and new parents', 'interventionNames': ['Behavioral: Breastfeeding']}, {'type': 'EXPERIMENTAL', 'label': 'Safe Sleep and Breastfeeding', 'description': 'Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and breastfeeding, and b) an online community and social network of other pregnant WIC clients and new parents', 'interventionNames': ['Behavioral: Safe Sleep', 'Behavioral: Breastfeeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early Brain Development and Parent -Child Relationships', 'description': 'Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for early brain development and parent-child interactions (control intervention) and b) an online community and social network of other pregnant WIC clients and new parents.', 'interventionNames': ['Behavioral: Early Brain Development and Parent-Child Relationships']}], 'interventions': [{'name': 'Safe Sleep', 'type': 'BEHAVIORAL', 'description': 'Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and b) an online community and social network of other pregnant WIC clients and new parents.', 'armGroupLabels': ['Safe Sleep', 'Safe Sleep and Breastfeeding']}, {'name': 'Breastfeeding', 'type': 'BEHAVIORAL', 'description': 'Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for breastfeeding and b) an online community and social network of other pregnant WIC clients and new parents.', 'armGroupLabels': ['Breastfeeding', 'Safe Sleep and Breastfeeding']}, {'name': 'Early Brain Development and Parent-Child Relationships', 'type': 'BEHAVIORAL', 'description': 'Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for early brain development and parent-child interactions (control intervention) and b) an online community and social network of other pregnant WIC clients and new parents.', 'armGroupLabels': ['Early Brain Development and Parent -Child Relationships']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine Boguszewski, MA', 'role': 'CONTACT', 'email': 'kbogusze@bu.edu', 'phone': '617-206-6269'}], 'facility': 'Boston University Medical Campus', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Katherine Boguszewski, MA', 'role': 'CONTACT', 'email': 'Keb5un@uvahealth.org', 'phone': '434-243-9663'}], 'overallOfficials': [{'name': 'Rachel Y Moon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston University', 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'Boston Medical Center', 'class': 'OTHER'}, {'name': 'University of Kentucky', 'class': 'OTHER'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Pediatrics', 'investigatorFullName': 'Rachel Moon, MD', 'investigatorAffiliation': 'University of Virginia'}}}}