Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT00222118
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kansas University Teen Mothers Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-08', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2012-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome is breastfeeding initiation at hospital discharge.', 'timeFrame': 'hospital discharge'}], 'secondaryOutcomes': [{'measure': 'Breastfeeding duration (in days) at 6 months postpartum', 'timeFrame': '6 months postpartum'}, {'measure': 'Knowledge, attitudes, subjective norms, perceived behavioral control, and intentions regarding infant feeding prenatally', 'timeFrame': 'at enrollment, 36 weeks of gestation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnant Adolescents']}, 'descriptionModule': {'briefSummary': 'Breastfeeding initiation and duration in adolescent mothers.', 'detailedDescription': "Randomized clinical trial to test the effects of a comprehensive prenatal, in-hospital, and postpartum education and support intervention on breastfeeding initiation and duration among teenage mothers. Experimental, attention control, and usual care groups are used to test the hypotheses. Drawing on the Theory of Planned Behavior and begun during the second trimester of pregnancy, the experimental condition uses a lactation consultant-peer counselor team to influence pregnant adolescents' beliefs and intentions about breastfeeding their newborns. The attention control (placebo) condition mimics the experimental condition, using an advanced practice nurse and peer counselor intervention team, and focuses on healthy pregnancy behaviors and labor/birth preparation. Teens in the two intervention groups attend two prenatal classes specific to their focus between the fourth and ninth month of pregnancy and receive telephone calls from a peer counselor. Teens in a usual care group receive no interventions beyond their standard prenatal care and education. After giving birth and still in the hospital, teens in the intervention groups receive a peer counselor phone call and visit. Breastfeeding teens in the experimental group also receive a breastfeeding counselor visit. After hospital discharge, breastfeeding teens from both intervention groups continue to receive peer counselor telephone support and, in the experimental condition, breastfeeding counselor phone calls for four weeks. Breastfeeding teens from all three groups complete short telephone interviews until six months after birth or until they stop breastfeeding."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 15-18 years\n2. Adolescents intending to keep their newborns\n3. 14 to 27 weeks of gestation\n4. Ability to speak and read English\n5. Possession or access to a telephone for study contact\n\nExclusion Criteria:\n\n1. Multiple gestation pregnancy\n2. Premature birth\n3. Infant with cleft lip/palate, congenital heart defects, Down Syndrome, neural tube defects, or other conditions warranting the newborn's admission to neonatal intensive care\n4. Subjects treated for significant complications during labor and birth that prohibit or delay breastfeeding beyond 48 hours or that have other conditions for which breastfeeding is contraindicated (e.g. HIV)"}, 'identificationModule': {'nctId': 'NCT00222118', 'briefTitle': 'Kansas University Teen Mothers Project', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Promoting and Supporting Breastfeeding in Adolescents', 'orgStudyIdInfo': {'id': 'R01NR007773-01A2', 'link': 'https://reporter.nih.gov/quickSearch/R01NR007773-01A2', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01NR007773-01A2', 'link': 'https://reporter.nih.gov/quickSearch/R01NR007773-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'intervention group', 'interventionNames': ['Other: intervention']}, {'type': 'OTHER', 'label': '2', 'description': 'Attention control', 'interventionNames': ['Behavioral: labor/birth preparation classes']}, {'type': 'OTHER', 'label': '3', 'description': 'Usual care', 'interventionNames': ['Other: usual care']}], 'interventions': [{'name': 'labor/birth preparation classes', 'type': 'BEHAVIORAL', 'description': 'prenatally, peer counselor/advanced practice nurse team, hospital visit, peer counselor telephone support for 4 weeks', 'armGroupLabels': ['2']}, {'name': 'intervention', 'type': 'OTHER', 'description': 'prenatal classes and phone calls from peer counselor, peer counselor/lactatin consultant, hospital visit, telephone support to 4 weeks postpartum', 'armGroupLabels': ['1']}, {'name': 'usual care', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Karen Wambach, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}