Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-05 @ 6:04 PM
Study NCT ID:
NCT03455257
Status:
UNKNOWN
Last Update Posted:
2018-03-06
First Post:
2018-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Cash Transfer Program in Low-Income Families in Guinea-Bissau
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Clarify randomization and masking'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participating families are randomized into one of two groups, an assessment-only controls group or a cash transfer group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34148}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2018-02-21', 'studyFirstSubmitQcDate': '2018-02-27', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in per capita food expeditures', 'timeFrame': 'Baseline, year 1, year 2 and year 3', 'description': 'change in per capita food expenditure per family will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Changes in family demographics', 'timeFrame': 'Baseline, year 1, year 2 and year 3', 'description': 'Changes in family demographics will be tracked.'}, {'measure': 'Change in weight', 'timeFrame': 'Baseline, year 1, year 2 and year 3', 'description': 'Change in weight for all participants in the study and children born after cash transfer program starts.'}, {'measure': 'Change in height', 'timeFrame': 'Baseline, year 1, year 2 and year 3', 'description': 'Change in height for all participants in the study and children born after cash transfer program starts.'}, {'measure': 'Change in mid-upper arm circumference (MUAC)', 'timeFrame': 'Baseline, year 1, year 2 and year 3', 'description': 'Change in MUAC for all participants in the study and children born after cash transfer program starts.'}, {'measure': 'Change in waist circumference', 'timeFrame': 'Baseline, year 1, year 2 and year 3', 'description': 'Change in waist circumference for all participants in the study and children born after cash transfer program starts.'}, {'measure': 'Change in hemoglobin', 'timeFrame': 'Baseline, year 1, year 2 and year 3', 'description': 'Change in hemoglobin for pregnant women, children born after the program begins, older children born in 2003, 2010, 2014.'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Baseline, year 1, year 2 and year 3', 'description': 'Change in blood pressure will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.'}, {'measure': 'Change in HbA1c', 'timeFrame': 'Baseline, year 1, year 2 and year 3', 'description': 'Change in HbA1c will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.'}, {'measure': 'Food intake', 'timeFrame': 'Year 1, year 2 and year 3', 'description': 'Food intake assessment'}, {'measure': 'Cognition function', 'timeFrame': 'When children are 18th months', 'description': 'Children born after the cash transfer progam will have a single cognitive function test at 18 months of age.'}, {'measure': 'Change in school attendence', 'timeFrame': 'Each semester of school in year 1, 2 and 3 of study', 'description': 'School enrollment, attendance, drop out and grade graduation will be assessed for all children through data extraction from school records.'}, {'measure': 'Change in head circumference', 'timeFrame': 'After birth, year 1, year 2, year 3', 'description': 'Children born after the cash transfer progam will have head circumference taken.'}, {'measure': 'Change in Literacy', 'timeFrame': 'Year 1, year 2, year 3', 'description': 'Children 7 and 14 will complete literacy testing.'}, {'measure': 'Change in Grip Strength', 'timeFrame': 'Baseline, year 1, year 2 and year 3', 'description': 'Change in grip strength will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Per Capita Food Consumption Expenditure', 'Childhood Growth', 'Childhood Cognition', 'Anemia', 'School Registration and Attendence', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'This pilot study will test the effect of a cash transfer program aiming to improve family food consumption patterns, family health and schooling, with resulting benefits for childhood growth and cognition.', 'detailedDescription': 'Cash transfer (CT) programs in low-income countries that allow recipients to receive cash designated for specific household expenditures such as food and family health and education typically show significant program benefits. In particular, several programs have shown positive impacts on use of health care resources, nutrition status and self-reported health, along with significant improvements in the motor and cognitive development of young children.\n\nGuinea-Bissau is currently the 11th poorest country and is thus an appropriate target for a cash transfer program. This project will pilot test the effect of a 2 year cash transfer program aiming to improve family food consumption patterns, family health and schooling, with resulting benefits for childhood growth and cognition. Family-wide assessment will be conducted to examine the impact in all family members. Baseline and 3 follow up assessments will be completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Families (defined as groups of individuals who routinely eat together) in 3 regions of Guinea-Bissau.\n* Identified by developing scale based upon household characteristics and assets per capita. As well as access to services such as water, electricity and sanitation.\n* Families having the lowest score identified as lowest income were recruited.\n\nExclusion Criteria:\n\n* Families with high scores on asset scale.\n* Families uninterested in participating.'}, 'identificationModule': {'nctId': 'NCT03455257', 'briefTitle': 'Evaluation of a Cash Transfer Program in Low-Income Families in Guinea-Bissau', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Finance, Guinea-Bissau'}, 'officialTitle': 'Evaluation of a Cash Transfer Program in Low-Income Families in Guinea-Bissau', 'orgStudyIdInfo': {'id': '1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Families assigned to this arm will be assessment only controls that do not receive the cash transfer.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Families assigned to this arm will recieve a cash transfer following an in-depth conversation with the head of household and the signing of a contract stating they understand the purpose of the study.', 'interventionNames': ['Behavioral: Cash Transfer']}], 'interventions': [{'name': 'Cash Transfer', 'type': 'BEHAVIORAL', 'description': 'The heads of households will receive a cash transfer for up to 7 family members in the home every quarter. Head of households will be expected to attend meetings every 4 months at their local community health centers led by Community Health Workers (CHW). Meetings will have 2 components: 1) children under 5 will be measured to identify children at risk of malnutrition and 2) group education sessions. There will also be monthly growth monitoring and education sessions led by CHW for a subgroup of head of households with children identified as risk of malnutrition with rapid referrals to regional tertiary clinics for any children with health problems that cannot be addressed by CHW.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bissau', 'country': 'Guinea-Bissau', 'facility': 'PDDC', 'geoPoint': {'lat': 11.86357, 'lon': -15.59767}}], 'overallOfficials': [{'name': 'Alfa U Jalo, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Finance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Finance, Guinea-Bissau', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'International Partnership for Human Development (IPHD)', 'class': 'UNKNOWN'}, {'name': 'National Institute of Statistics (INE)', 'class': 'UNKNOWN'}, {'name': 'World Bank', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}