Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT01352351
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
2011-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 485}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-06', 'studyFirstSubmitDate': '2011-05-10', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of women who exclusively breastfeed to 6 months', 'timeFrame': 'The outcome will be measured when the infant is 6-7 months old.'}], 'secondaryOutcomes': [{'measure': 'Proportion of women who exclusively breastfeed for 0-1 month', 'timeFrame': 'The outcome will be measured when the infant is 6-7 months old.'}, {'measure': 'Proportion of women who exclusively breastfeed for 2-3 months', 'timeFrame': 'The outcome will be measured when the infant is 6-7 months old.'}, {'measure': 'Initiation of breastfeeding within 1 hour of birth', 'timeFrame': 'The outcome will be measured when the infant is 6-7 months old.'}, {'measure': 'Proportion of infants who receive pre-lacteal feeds', 'timeFrame': 'The outcome will be measured when the infant is 6-7 months old.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast feeding Exclusive', 'Initiation of breastfeeding'], 'conditions': ['Breast Feeding Exclusive', 'Initiation of Breastfeeding']}, 'referencesModule': {'references': [{'pmid': '24812071', 'type': 'DERIVED', 'citation': "Flax VL, Negerie M, Ibrahim AU, Leatherman S, Daza EJ, Bentley ME. Integrating group counseling, cell phone messaging, and participant-generated songs and dramas into a microcredit program increases Nigerian women's adherence to international breastfeeding recommendations. J Nutr. 2014 Jul;144(7):1120-4. doi: 10.3945/jn.113.190124. Epub 2014 May 8."}]}, 'descriptionModule': {'briefSummary': "The University of North Carolina (UNC) and Partners for Development (PFD), an American non-governmental organization, will conduct a 2-year cluster-randomized controlled trial in Bauchi State, Nigeria, to test the effectiveness of two behavior change strategies for increasing the proportion of participants who exclusively breastfeed their infants until 6 months. The investigators will build upon PFD's existing microcredit and reproductive health program by adding face-to-face breastfeeding education during borrowers' meetings and bi-weekly cell phone breastfeeding messages. The hypothesis is that the control group will remain at the baseline level for exclusive breastfeeding to 6 months, while the intervention group will increase by 15%. The investigators will measure the effectiveness of the intervention by conducting baseline and final surveys with a cohort of 485 female borrowers who are pregnant at time 1 and who have a 6-month-old infant at time 2. The data will be analyzed using logistic regression adjusting for possible confounders and the effect of clustering."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in a microcredit borrower group sponsored by Partners for Development in Bauchi, Dass, or Ganjuwa Local Government Authority in Bauchi State, Nigeria\n* Female (15-45 years)\n* Pregnant at baseline\n\nExclusion Criteria:\n\n* Female (\\<15 years)\n* Not pregnant'}, 'identificationModule': {'nctId': 'NCT01352351', 'briefTitle': 'Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Linking Microcredit, Technology, and Promotion of IYCF Breastfeeding Guidelines in Bauchi State, Nigeria', 'orgStudyIdInfo': {'id': '11-0534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breastfeeding promotion intervention', 'description': 'Intervention:\n\n* Group breastfeeding counseling during monthly microcredit borrower group meetings\n* Weekly cell phone messages about breastfeeding', 'interventionNames': ['Behavioral: Breastfeeding promotion intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'The no intervention group will participate in their regular microcredit borrower group meetings, but will not receive breastfeeding counseling or cell phone messages.'}], 'interventions': [{'name': 'Breastfeeding promotion intervention', 'type': 'BEHAVIORAL', 'description': '* Breastfeeding counseling during monthly microcredit meetings\n* Weekly cell phone messages about breastfeeding', 'armGroupLabels': ['Breastfeeding promotion intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Margaret E. Bentley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill'}, {'name': 'Valerie L. Flax, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill'}, {'name': 'Mekebeb Negerie, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Partners for Development/Nigeria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Davis', 'class': 'OTHER'}, {'name': 'Partners for Development', 'class': 'UNKNOWN'}, {'name': 'The Alive & Thrive Small Grants', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}