Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-02-20 @ 3:32 PM
Study NCT ID:
NCT03680235
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2018-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Informational Intervention in Increasing Lactation Practices by African American Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2018-09-19', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breastfeeding rates', 'timeFrame': 'Up to 1 year', 'description': 'Will be assessed by estimating a logistic regression model with breastfeeding as the dichotomous outcome variable and intervention condition as a predictor variable.'}, {'measure': 'Behavioral intentions for breastfeeding', 'timeFrame': 'Up to 1 year', 'description': 'Linear regression analyses will be conducted with condition and necessary covariates as predictors.'}, {'measure': 'Perceived risk for breast cancer', 'timeFrame': 'Up to 1 year', 'description': 'Linear regression analyses will be conducted with condition and necessary covariates as predictors. Will examine the degree to which perceived risk for breast cancer mediate any intervention impact on breastfeeding behavior and behavioral intentions.'}, {'measure': 'Affective associations with breastfeeding', 'timeFrame': 'Up to 1 year', 'description': 'Linear regression analyses will be conducted with condition and necessary covariates as predictors. Will examine the degree to which affective associations with breastfeeding mediate any intervention impact on breastfeeding behavior and behavioral intentions.'}, {'measure': 'Perceptions of benefits and barriers to breastfeeding', 'timeFrame': 'Up to 1 year', 'description': 'Linear regression analyses will be conducted with condition and necessary covariates as predictors. Will examine the degree to which perceptions of benefits and barriers to breastfeeding mediate any intervention impact on breastfeeding behavior and behavioral intentions.'}, {'measure': 'Qualitative analysis of focus group and key informant interviews', 'timeFrame': 'Up to 1 year', 'description': 'Will be recorded and transcribed. This text will be coded and categorized by Erwin following methods established in earlier research. The PEN-3 Model analysis will focus on the most salient factors as they apply to what will be considered the ?Positive, Existential, Negative? influences within the Cultural Empowerment domain in reference to breastfeeding and formula feeding topics. Will sort the responses into categories in a 3 x 3 table according to the Relationships and Expectations domain factors, ?Perceptions, Enablers, Nurturers,? on one axis, and the ?Positive, Existential, Negative? factors across the other axis. This categorical analysis will be reviewed and edited and the Women, Infants and Children (WIC) peer counselors (PCs) to increase validity of the process.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subject', 'Pregnant']}, 'referencesModule': {'references': [{'pmid': '32773377', 'type': 'DERIVED', 'citation': 'Dauphin C, Clark N, Cadzow R, Saad-Harfouche F, Rodriguez E, Glaser K, Kiviniemi M, Keller M, Erwin D. #BlackBreastsMatter: Process Evaluation of Recruitment and Engagement of Pregnant African American Women for a Social Media Intervention Study to Increase Breastfeeding. J Med Internet Res. 2020 Aug 10;22(8):e16239. doi: 10.2196/16239.'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how well an informational intervention works in increasing lactation practices by African American women. Giving additional information about breastfeeding and breast cancer risks to African American women may help doctors understand the factors that affect the decision to breast feed and to test whether providing useful information about breastfeeding will change breastfeeding behavior.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Develop appropriate intervention strategies about the "breastfeeding-breast cancer connection" appropriate for use by experienced Women, Infants and Children (WIC) Peer Counselors (PCs) to disseminate to African-American mothers through a community-based participatory research (CBPR) approach including social media..\n\nII. Assess the comparative cognitive (e.g., knowledge, utility, cost-benefit), affective association (e.g., feelings), socioeconomic, familial and intent/outcome (e.g., breastfeeding) measures pre- and post-intervention to determine effectiveness of the content to impact cognitive and feeling measures and increase breastfeeding in young African-American mothers compared to an existing counseling program.\n\nOUTLINE: Participants are assigned to 1 of 2 groups.\n\nGROUP I: Participants receive standard information about pregnancy and breastfeeding. Participants may also participate in a focus group with their partner/spouse or family members after the baby\'s birth.\n\nGROUP II: Participants receive standard information about pregnancy and breastfeeding as well as information about breastfeeding and breast cancer. Participants may also participate in a focus group with their partner/spouse or family members after the baby\'s birth.\n\nAfter completion of the information intervention, participants are followed for up to 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant African American women participating in the Catholic Charities WIC Program\n* INCLUSION - FOCUS GROUPS: Representative mothers, spouses/partners, influential family members (e.g., grandmothers, sisters) from the families served during the study.\n* INCLUSION - FOCUS GROUPS: Partners/spouses may include men or women.\n\nExclusion Criteria:\n\n* Unwilling or unable to follow protocol requirements.'}, 'identificationModule': {'nctId': 'NCT03680235', 'briefTitle': 'Informational Intervention in Increasing Lactation Practices by African American Women', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Novel Intervention to Increase Lactation Practices by African American Women', 'orgStudyIdInfo': {'id': 'I 270615'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00854', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 270615', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}, {'id': 'R21CA202263', 'link': 'https://reporter.nih.gov/quickSearch/R21CA202263', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I: (standard information about pregnancy, breastfeeding)', 'description': "Participants receive standard information about pregnancy and breastfeeding. Participants may also participate in a focus group with their partner/spouse or family members after the baby's birth.", 'interventionNames': ['Other: Informational Intervention', 'Other: Interview', 'Other: Survey Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (information about breastfeeding and cancer)', 'description': "Participants receive standard information about pregnancy and breastfeeding as well as information about breastfeeding and breast cancer. Participants may also participate in a focus group with their partner/spouse or family members after the baby's birth.", 'interventionNames': ['Other: Informational Intervention', 'Other: Interview', 'Other: Survey Administration']}], 'interventions': [{'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Receive standard information about breastfeeding and pregnancy', 'armGroupLabels': ['Group I: (standard information about pregnancy, breastfeeding)', 'Group II (information about breastfeeding and cancer)']}, {'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'Receive information about breastfeeding and cancer', 'armGroupLabels': ['Group II (information about breastfeeding and cancer)']}, {'name': 'Interview', 'type': 'OTHER', 'description': 'Participate in focus groups', 'armGroupLabels': ['Group I: (standard information about pregnancy, breastfeeding)', 'Group II (information about breastfeeding and cancer)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I: (standard information about pregnancy, breastfeeding)', 'Group II (information about breastfeeding and cancer)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Deborah Erwin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}