Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
Study NCT ID:
NCT04621266
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2020-10-29
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Home Based Peer Support Program for Mothers With Low Breastfeeding Self-efficacy
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': 'krislok@hku.hk', 'phone': '39176690', 'title': 'Dr Kris Lok', 'organization': 'The University of Hong Kong'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1-month, 2-month, 4-month, 6-month', 'description': 'No adverse effect is reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes.", 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 0, 'seriousNumAtRisk': 224, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 218, 'otherNumAffected': 0, 'seriousNumAtRisk': 218, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Infant Feeding Status: Exclusive Breastfeeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. 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Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 1 month postpartum', 'description': 'Number/ proportion of participants who practice exclusive breastfeeding at 1 months postpartum.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Infant Feeding Status: Exclusive Breastfeeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. 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Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 2 months postpartum', 'description': 'Number/ proportion of participants who practiced exclusive breastfeeding at 2 month postpartum.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Infant Feeding Status: Exclusive Breastfeeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 4 months postpartum', 'description': 'Number/ proportion of participants that practice exclusive breastfeeding at 4 months postpartum.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Infant Feeding Status: Exclusive Breastfeeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6 months postpartum', 'description': 'Number/ proportion of participants that practice exclusive breastfeeding at 6 months postpartum.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Women's Self-efficacy in Breastfeeding", 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '40.7', 'spread': '11.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline, 2 months and 4 months postpartum', 'description': 'Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Women's Self-efficacy in Breastfeeding at Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '37', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Women's Self-efficacy in Breastfeeding at 2 Months Postpartum", 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 2 months postpartum', 'description': 'Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Women's Self-efficacy in Breastfeeding at 4 Months Postpartum", 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 4 months postpartum', 'description': 'Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Women's Postpartum Depression at Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms. It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30. In general, a higher score indicates more severe depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Women's Postpartum Depression at 1 Month Postpartum", 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 month postpartum', 'description': 'The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms. It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30. In general, a higher score indicates more severe depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Women's Postpartum Depression at 2 Month Postpartum", 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'OG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 2 month postpartum', 'description': 'The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms. It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30. In general, a higher score indicates more severe depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'FG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '218'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '214'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Online Home-based Peer Support Intervention', 'description': "Participants will receive intervention on top of standard usual care.\n\nOnline Home-based peer support: Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes."}, {'id': 'BG001', 'title': 'Standard Usual Care', 'description': 'Participants will receive standard usual care.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '442', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-06', 'size': 208390, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-05T04:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 442}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2020-10-29', 'resultsFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-06', 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant Feeding Status: Exclusive Breastfeeding', 'timeFrame': 'At 1 month postpartum', 'description': 'Number/ proportion of participants who practice exclusive breastfeeding at 1 months postpartum.'}, {'measure': 'Infant Feeding Status: Exclusive Breastfeeding', 'timeFrame': 'At 2 months postpartum', 'description': 'Number/ proportion of participants who practiced exclusive breastfeeding at 2 month postpartum.'}, {'measure': 'Infant Feeding Status: Exclusive Breastfeeding', 'timeFrame': 'At 4 months postpartum', 'description': 'Number/ proportion of participants that practice exclusive breastfeeding at 4 months postpartum.'}, {'measure': 'Infant Feeding Status: Exclusive Breastfeeding', 'timeFrame': 'At 6 months postpartum', 'description': 'Number/ proportion of participants that practice exclusive breastfeeding at 6 months postpartum.'}], 'secondaryOutcomes': [{'measure': "Women's Self-efficacy in Breastfeeding", 'timeFrame': 'At baseline, 2 months and 4 months postpartum', 'description': 'Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.'}, {'measure': "Women's Self-efficacy in Breastfeeding at Baseline", 'timeFrame': 'At baseline', 'description': 'Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.'}, {'measure': "Women's Self-efficacy in Breastfeeding at 2 Months Postpartum", 'timeFrame': 'At 2 months postpartum', 'description': 'Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.'}, {'measure': "Women's Self-efficacy in Breastfeeding at 4 Months Postpartum", 'timeFrame': 'At 4 months postpartum', 'description': 'Breastfeeding Self-efficacy Scale Short Form (Hong Kong Chinese version) is used to measure maternal breastfeeding self-efficacy. The 14-item scale is on a 5-point Likert scale. Total score ranged from 14 to 70 with a higher score indicating higher breastfeeding confidence and self-efficacy. A cut-off score of 46 is applied after rounding up to the nearest integer.'}, {'measure': "Women's Postpartum Depression at Baseline", 'timeFrame': 'At baseline', 'description': 'The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms. It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30. In general, a higher score indicates more severe depressive symptoms.'}, {'measure': "Women's Postpartum Depression at 1 Month Postpartum", 'timeFrame': 'At 1 month postpartum', 'description': 'The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms. It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30. In general, a higher score indicates more severe depressive symptoms.'}, {'measure': "Women's Postpartum Depression at 2 Month Postpartum", 'timeFrame': 'At 2 month postpartum', 'description': 'The Chinese version of the Edinburgh Postnatal Depression Scale is used to measure the severity of postnatal depressive symptoms. It is a ten-item scale rated from 0 to 3. The total score could range from 0 to 30. In general, a higher score indicates more severe depressive symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breastfeeding']}, 'referencesModule': {'references': [{'pmid': '39043588', 'type': 'DERIVED', 'citation': 'Lok KYW, Choi MSL, Ko RWT, Chau PPH, Lam CCO, Chang YS, Bick D. Effectiveness of a home-based peer support programme for Chinese mothers with low breastfeeding self-efficacy to increase the exclusivity and duration of breastfeeding: study protocol of a randomised control trial. BMJ Open. 2024 Jul 23;14(7):e081897. doi: 10.1136/bmjopen-2023-081897.'}]}, 'descriptionModule': {'briefSummary': 'An online home-based breastfeeding peer support programme is proposed to support mothers who are giving birth to their first-born. This study aims to evaluate the effectiveness of this programme in improving breastfeeding practices among women with low breastfeeding self-efficacy. It is hypothesized that participants who received online home-based peer support will exclusively breastfeed for longer duration, have higher breastfeeding self-efficacy, and lower post-partum depression symptoms when compared to those receiving only standard care.', 'detailedDescription': 'Primiparous mothers who plan to breastfeed but did not go on to breastfeed often face high levels of emotional and psychological challenges in their transition to parenthood. This can adversely affect their breastfeeding experiences and general well-being, and is associated with stress, anxiety, and postnatal depression. While family psycho-education and other supportive group programmes are available in health services, they require face-to-face education sessions over a long interval, high engagement, and trusting relationships, and thus often result in low attendance and high drop outs.\n\nMothers have expressed the need for psychological support of peer counsellors, which would allow them to support each other. The first month postpartum is a critical period for sustaining exclusive breastfeeding and the time when mothers are at high risk of postpartum depression. For Chinese mothers in Hong Kong, however, they are often housebound during this period due to the tradition of "doing the month", and thus often find it difficult to attend support groups or seek help. In view of these challenges and the pandemic wave faced by primiparous mothers, they are reluctant with home visits, therefore an online delivery of the home-based peer support programme is proposed.\n\nThis randomized control trial adopts a two-arm design to examine the effectiveness of an online home-based peer support programme for women with low breastfeeding self-efficacy. It is hypothesized that those receiving the intervention, when compared to the controls, will have (1) longer period of exclusive breastfeeding, (2) higher postnatal breastfeeding self-efficacy, and (3) lower post-partum depressive symptoms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primiparous mothers\n* Intend to breastfeed\n* Have low breastfeeding self-efficacy (between 14 to 32)\n* Have singleton pregnancy and live birth\n* Have term infant (37-42 weeks gestational)\n* Cantonese speaking\n* Hong Kong resident\n* Have no serious medical or obstetrical complications\n\nExclusion Criteria:\n\n* Infant is \\<37 week gestation\n* Infant has Apgar score \\<8 at five minutes\n* Infant has birthweight \\<2,500 grams\n* Infant has any severe medical conditions or congenital malformations\n* Infant is placed in the special care baby unit for more than 48 hours after birth\n* Infant is placed in the neonatal intensive care unit at any time after birth'}, 'identificationModule': {'nctId': 'NCT04621266', 'acronym': 'BFPS', 'briefTitle': 'Home Based Peer Support Program for Mothers With Low Breastfeeding Self-efficacy', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Effectiveness of a Home-based Peer Support Program for Chinese Mothers With Low Breastfeeding Self-efficacy to Increase the Exclusivity and Duration of Breastfeeding: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BFPS1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online Home-based peer support intervention', 'description': 'Participants will receive intervention on top of standard usual care.', 'interventionNames': ['Behavioral: Online Home-based peer support']}, {'type': 'NO_INTERVENTION', 'label': 'Standard usual care', 'description': 'Participants will receive standard usual care.'}], 'interventions': [{'name': 'Online Home-based peer support', 'type': 'BEHAVIORAL', 'description': "Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes.", 'armGroupLabels': ['Online Home-based peer support intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Kris YW Lok, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}