Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-30 @ 9:00 PM
Study NCT ID:
NCT01272661
Status:
COMPLETED
Last Update Posted:
2015-01-05
First Post:
2010-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lydia.Furman@uhhospitals.org', 'phone': '216-844-8260', 'title': 'Lydia Furman MD, PI', 'organization': "UHospitalsCleveland; Rainbow Babies and CHildren's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': 'Adverse events were not identified.', 'eventGroups': [{'id': 'EG000', 'title': 'Enhanced Curriculum', 'description': 'New Enhanced Breastfeeding Curriculum with 11 brief modules\n\nEnhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers', 'otherNumAtRisk': 413, 'otherNumAffected': 0, 'seriousNumAtRisk': 413, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Curriculum+Breastfeeding Doula', 'description': 'Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")\n\nEnhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.', 'otherNumAtRisk': 497, 'otherNumAffected': 0, 'seriousNumAtRisk': 497, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Enhanced Curriculum+Father Support Program', 'description': 'Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers\n\nEnhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.', 'otherNumAtRisk': 386, 'otherNumAffected': 0, 'seriousNumAtRisk': 386, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Program Feasibility- Feeding Outcome Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '497', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Curriculum', 'description': 'New Enhanced Breastfeeding Curriculum with 11 brief modules\n\nEnhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers'}, {'id': 'OG001', 'title': 'Enhanced Curriculum+Breastfeeding Doula', 'description': 'Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")\n\nEnhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.'}, {'id': 'OG002', 'title': 'Enhanced Curriculum+Father Support Program', 'description': 'Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers\n\nEnhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.'}], 'classes': [{'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'by 24 months', 'description': 'Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of eligible MomsFirst participants who agreed to data sharing. Outcome shows number w/ any feeding outcome (not lost to follow up, no live birth, case closed by MomsFirst). This is for a 24 month period since all data was de-identified and stripped of dates so unable to specify for 12 month period'}, {'type': 'PRIMARY', 'title': 'Program Feasibility - Curriculum Modules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '314', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Curriculum', 'description': 'New Enhanced Breastfeeding Curriculum with 11 brief modules\n\nEnhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers'}, {'id': 'OG001', 'title': 'Enhanced Curriculum+Breastfeeding Doula', 'description': 'Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")\n\nEnhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.'}, {'id': 'OG002', 'title': 'Enhanced Curriculum+Father Support Program', 'description': 'Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers\n\nEnhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'by 24 months from program start', 'description': 'Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11', 'unitOfMeasure': 'modules presented', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Breastfeeding Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Curriculum', 'description': 'New Enhanced Breastfeeding Curriculum with 11 brief modules\n\nEnhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers'}, {'id': 'OG001', 'title': 'Enhanced Curriculum+Breastfeeding Doula', 'description': 'Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")\n\nEnhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.'}, {'id': 'OG002', 'title': 'Enhanced Curriculum+Father Support Program', 'description': 'Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers\n\nEnhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours', 'description': 'Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis was conducted on participants with available data'}, {'type': 'SECONDARY', 'title': 'Breastfeeding Rate at One Month Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Curriculum', 'description': 'New Enhanced Breastfeeding Curriculum with 11 brief modules\n\nEnhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers'}, {'id': 'OG001', 'title': 'Enhanced Curriculum+Breastfeeding Doula', 'description': 'Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")\n\nEnhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.'}, {'id': 'OG002', 'title': 'Enhanced Curriculum+Father Support Program', 'description': 'Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers\n\nEnhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Any and exclusive breastfeeding at one month, between 21-38 days postpartum', 'description': 'Measure rate of breastfeeding (rate of any breastfeeding is main measure, also measure rate of exclusive breastfeeding) at one month postpartum. Will compare rate of any breastfeeding one month postpartum to historical data, and will compare rates of any breastfeeding at one month postpartum between intervention groups.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis conducted on participants with available data'}, {'type': 'SECONDARY', 'title': 'Breastfeeding Rate at 3 Months Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Curriculum', 'description': 'New Enhanced Breastfeeding Curriculum with 11 brief modules\n\nEnhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers'}, {'id': 'OG001', 'title': 'Enhanced Curriculum+Breastfeeding Doula', 'description': 'Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")\n\nEnhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.'}, {'id': 'OG002', 'title': 'Enhanced Curriculum+Father Support Program', 'description': 'Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers\n\nEnhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum', 'description': 'Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis conducted on participants with available data'}, {'type': 'SECONDARY', 'title': 'Breastfeeding Rate at 6 Months Postpartum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Curriculum', 'description': 'New Enhanced Breastfeeding Curriculum with 11 brief modules\n\nEnhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers'}, {'id': 'OG001', 'title': 'Enhanced Curriculum+Breastfeeding Doula', 'description': 'Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")\n\nEnhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.'}, {'id': 'OG002', 'title': 'Enhanced Curriculum+Father Support Program', 'description': 'Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers\n\nEnhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum', 'description': 'Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis conducted on participants with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enhanced Curriculum', 'description': 'New Enhanced Breastfeeding Curriculum with 11 brief modules\n\nEnhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers'}, {'id': 'FG001', 'title': 'Enhanced Curriculum+Breastfeeding Doula', 'description': 'Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")\n\nEnhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.'}, {'id': 'FG002', 'title': 'Enhanced Curriculum +Father Support', 'description': 'Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers\n\nEnhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '413'}, {'groupId': 'FG001', 'numSubjects': '497'}, {'groupId': 'FG002', 'numSubjects': '386'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '288'}, {'groupId': 'FG002', 'numSubjects': '314'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'lost to followup/case closed/ no birth', 'reasons': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '72'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'BG000'}, {'value': '497', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}, {'value': '1296', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Enhanced Curriculum', 'description': 'New Enhanced Breastfeeding Curriculum with 11 brief modules\n\nEnhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers'}, {'id': 'BG001', 'title': 'Enhanced Curriculum+Breastfeeding Doula', 'description': 'Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")\n\nEnhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.'}, {'id': 'BG002', 'title': 'Enhanced Curriculum+Father Support', 'description': 'Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers\n\nEnhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.2', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '22.2', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '23.1', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '22.2', 'spread': '4.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '413', 'groupId': 'BG000'}, {'value': '497', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}, {'value': '1296', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '413', 'groupId': 'BG000'}, {'value': '497', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}, {'value': '1296', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-11', 'studyFirstSubmitDate': '2010-12-27', 'resultsFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2011-01-07', 'lastUpdatePostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-27', 'studyFirstPostDateStruct': {'date': '2011-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Program Feasibility- Feeding Outcome Collected', 'timeFrame': 'by 24 months', 'description': 'Measure program feasibility by number of participants who were exposed to the intervention for whom there is any feeding outcome'}, {'measure': 'Program Feasibility - Curriculum Modules', 'timeFrame': 'by 24 months from program start', 'description': 'Measure program feasibility by counting the number of Breastfeeding Curricular modules that were presented of total possible = 11'}], 'secondaryOutcomes': [{'measure': 'Breastfeeding Rate', 'timeFrame': 'Any breastfeeding: participants were followed for the duration of hospital stay, an average of 48 hours', 'description': 'Measure rate of any breastfeeding (breastfeeding initiation) in the hospital. We will also compare this rate between the 3 intervention groups.'}, {'measure': 'Breastfeeding Rate at One Month Postpartum', 'timeFrame': 'Any and exclusive breastfeeding at one month, between 21-38 days postpartum', 'description': 'Measure rate of breastfeeding (rate of any breastfeeding is main measure, also measure rate of exclusive breastfeeding) at one month postpartum. Will compare rate of any breastfeeding one month postpartum to historical data, and will compare rates of any breastfeeding at one month postpartum between intervention groups.'}, {'measure': 'Breastfeeding Rate at 3 Months Postpartum', 'timeFrame': 'Any and exclusive breastfeeding at 3 months, between 10-14 weeks postpartum', 'description': 'Measure rates of any and exclusive breastfeeding at 3 months postpartum. Rate of any breastfeeding is presented.'}, {'measure': 'Breastfeeding Rate at 6 Months Postpartum', 'timeFrame': 'Any and exclusive breastfeeding at 6 months, between 22-26 weeks postpartum', 'description': 'Measure breastfeeding rate (any and exclusive) at 6 months postpartum. Rate of any breastfeeding is presented.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breastfeeding', 'low-income', 'high-risk', 'African-American', 'health disparity'], 'conditions': ['Breastfeeding']}, 'descriptionModule': {'briefSummary': 'Breast for Success is a new direct service program focused on overcoming barriers to breastfeeding for low-income inner-city mothers by use of a culturally competent and home-based educational and support intervention. Key project components include a new Enhanced Breastfeeding Curriculum with brief engaging health literacy focused modules, and two innovative support plans, the Breastfeeding Doula and Father Support Programs. The objective is to increase breastfeeding rates for high-risk inner-city mothers.\n\nResearch Questions to evaluate project feasibility and effectiveness are:\n\n1. Were all aspects of the Curriculum and Doula and Father Support Programs implemented?\n2. Is there an increase in the rate of any breastfeeding at 1 month postpartum for all mothers?\n3. Is there a difference in the rate of any breastfeeding at 1 month postpartum between interventions (Curriculum only, Curriculum+Doula Support, Curriculum+Father Support)?\n4. What are exclusive breastfeeding rates at 1, 3 and 6 months for all mothers?', 'detailedDescription': 'Low rates of breastfeeding among low-income inner-city mothers represent a challenging health disparity that adversely impacts child and maternal health. The overall objective of Breast for Success is to increase the rates of breastfeeding initiation, continuation and exclusivity among high-risk mothers in the City of Cleveland via home-based culturally appropriate interventions. Key project components include a new Curriculum with brief engaging modules utilizing games, teach-reteach strategies, and interactive learning to address specific barriers identified in focus groups (e.g. pain, low milk supply, breast "myths"), and two innovative support components, the Breastfeeding Doula and Father Support Programs. Breast for Success was developed in collaboration with and will be disseminated in partnership with the Cleveland Department of Public Health MomsFirst initiative (a Healthy Start Program), which delivers comprehensive services including twice-monthly Community Health Worker home visits prenatally through 2 years postpartum to 500 women annually. The investigators will measure program success via participation logs, satisfaction questionnaires and breastfeeding rates at 1, 3 and 6 months postpartum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant woman enrolled in MomsFirst Program of Greater Cleveland\n\nExclusion Criteria:\n\n* incarceration\n\nOther study populations include the Community Health Workers, the doulas and the fathers of the study mothers.'}, 'identificationModule': {'nctId': 'NCT01272661', 'acronym': 'BFS', 'briefTitle': 'Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Breast for Success: A Family-Centered Intervention in Support of Breastfeeding Among High-risk Low-income Mothers in Cleveland', 'orgStudyIdInfo': {'id': 'BFS-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Curriculum', 'description': 'New Enhanced Breastfeeding Curriculum with 11 brief modules', 'interventionNames': ['Behavioral: Enhanced Curriculum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Curriculum+Breastfeeding Doula', 'description': 'Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum ("breastfeeding doula")', 'interventionNames': ['Behavioral: Enhanced Curriculum+Breastfeeding Doula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Curriculum +Father Support', 'description': 'Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers', 'interventionNames': ['Behavioral: Enhanced Curriculum +Father Support']}], 'interventions': [{'name': 'Enhanced Curriculum', 'type': 'BEHAVIORAL', 'description': 'Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers', 'armGroupLabels': ['Enhanced Curriculum']}, {'name': 'Enhanced Curriculum+Breastfeeding Doula', 'type': 'BEHAVIORAL', 'description': 'In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.', 'armGroupLabels': ['Enhanced Curriculum+Breastfeeding Doula']}, {'name': 'Enhanced Curriculum +Father Support', 'type': 'BEHAVIORAL', 'description': 'In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.', 'armGroupLabels': ['Enhanced Curriculum +Father Support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44114', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MomsFirst', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Lydia M Furman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Academy of Pediatrics', 'class': 'OTHER'}, {'name': 'Mt. Sinai Health Care Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Lydia Furman', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}