Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 11:34 AM
Study NCT ID:
NCT03901833
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2019-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LIFT: Telemedicine Breastfeeding Support
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experience', 'timeFrame': 'One month post-enrollment', 'description': 'Mean score on a modified, 16-item Interactive Telehealth Satisfaction Scale \\>48 (corresponding to better than neutral on a 5 point Likert scale, 16 questions).'}], 'secondaryOutcomes': [{'measure': 'Time to cessation', 'timeFrame': 'Monthly up to 12 months', 'description': 'Time to breastfeeding cessation (assessed via monthly surveys as no to infant receiving any breast milk in last 24 hours)'}, {'measure': 'Exclusive breastfeeding cessation', 'timeFrame': 'Monthly up to 12 months', 'description': 'Time to exclusive breastfeeding cessation (assessed via monthly surveys, defined by initiation of formula, water, juice, other liquids, or solid foods)'}, {'measure': 'Breastfeeding at 3 months', 'timeFrame': '3 months', 'description': "Proportion of infants breastfeeding at 3 months (assessed via 24 hour recall from infant's mother)"}, {'measure': 'Exclusive breastfeeding', 'timeFrame': '3 months', 'description': "Proportion of infants breastfeeding without supplementation with other food or liquids at 3 months (assessed via 24 hour recall from infant's mother)"}, {'measure': 'Individual satisfaction questions', 'timeFrame': '1 month post enrollment', 'description': 'Mean satisfaction on each Interactive Telehealth Satisfaction Scale question'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breastfeeding']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://studypages.com/s/the-lift-study-telemedicine-breastfeeding-support-612908/', 'label': 'Learn more or sign up for the study here!'}]}, 'descriptionModule': {'briefSummary': 'The central hypothesis guiding this project is that tailored breastfeeding support, that leverages easily accessible telemedicine technologies, can improve breastfeeding outcomes among late preterm dyads. The long-term goals of this project are to improve maternal and child health and reduce health disparities by designing and implementing evidence-based interventions to improve breastfeeding outcomes for this challenging patient population. This study seeks to identify lactation support practices that improve breastfeeding duration and to test the effect of telemedicine breastfeeding support on breastfeeding duration, among the nearly one in ten mothers who deliver late preterm (34-37 6/7 weeks), as this subpopulation of mothers faces the highest rates of premature breastfeeding cessation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* maternal age 18-49 years\n* late preterm delivery (34-37 6/7 weeks)\n* enrollment up to 1 week postpartum\n* breastfeeding initiated\n* access to a smartphone, tablet, or laptop computer in their home\n\nExclusion Criteria:\n\n* incarceration\n* inability to communicate in English\n* infant with medical condition compromising breastfeeding (e.g. cleft lip and/or palate).'}, 'identificationModule': {'nctId': 'NCT03901833', 'briefTitle': 'LIFT: Telemedicine Breastfeeding Support', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Telemedicine Breastfeeding Support Following Late Preterm Delivery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1382496'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemedicine Support', 'description': 'Weekly telemedicine breastfeeding support visits for four weeks, delivered via telemedicine', 'interventionNames': ['Behavioral: Telemedicine Support']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Standard of care', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'Telemedicine Support', 'type': 'BEHAVIORAL', 'description': 'Telemedicine intervention', 'armGroupLabels': ['Telemedicine Support']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Standard of Care', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California-Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Laura Kair, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}