- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03455257
Evaluation of a Cash Transfer Program in Low-Income Families in Guinea-Bissau
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Guinea-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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bissau, Guinea-Bissau
- PDDC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Families (defined as groups of individuals who routinely eat together) in 3 regions of Guinea-Bissau.
- Identified by developing scale based upon household characteristics and assets per capita. As well as access to services such as water, electricity and sanitation.
- Families having the lowest score identified as lowest income were recruited.
Exclusion Criteria:
- Families with high scores on asset scale.
- Families uninterested in participating.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Families assigned to this arm will be assessment only controls that do not receive the cash transfer.
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Experimental: Intervention
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in per capita food expeditures
Time Frame: Baseline, year 1, year 2 and year 3
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change in per capita food expenditure per family will be calculated.
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Baseline, year 1, year 2 and year 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in family demographics
Time Frame: Baseline, year 1, year 2 and year 3
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Changes in family demographics will be tracked.
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Baseline, year 1, year 2 and year 3
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Change in weight
Time Frame: Baseline, year 1, year 2 and year 3
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Change in weight for all participants in the study and children born after cash transfer program starts.
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Baseline, year 1, year 2 and year 3
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Change in height
Time Frame: Baseline, year 1, year 2 and year 3
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Change in height for all participants in the study and children born after cash transfer program starts.
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Baseline, year 1, year 2 and year 3
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Change in mid-upper arm circumference (MUAC)
Time Frame: Baseline, year 1, year 2 and year 3
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Change in MUAC for all participants in the study and children born after cash transfer program starts.
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Baseline, year 1, year 2 and year 3
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Change in waist circumference
Time Frame: Baseline, year 1, year 2 and year 3
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Change in waist circumference for all participants in the study and children born after cash transfer program starts.
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Baseline, year 1, year 2 and year 3
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Change in hemoglobin
Time Frame: Baseline, year 1, year 2 and year 3
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Change in hemoglobin for pregnant women, children born after the program begins, older children born in 2003, 2010, 2014.
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Baseline, year 1, year 2 and year 3
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Change in blood pressure
Time Frame: Baseline, year 1, year 2 and year 3
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Change in blood pressure will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.
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Baseline, year 1, year 2 and year 3
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Change in HbA1c
Time Frame: Baseline, year 1, year 2 and year 3
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Change in HbA1c will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.
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Baseline, year 1, year 2 and year 3
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Food intake
Time Frame: Year 1, year 2 and year 3
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Food intake assessment
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Year 1, year 2 and year 3
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Cognition function
Time Frame: When children are 18th months
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Children born after the cash transfer progam will have a single cognitive function test at 18 months of age.
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When children are 18th months
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Change in school attendence
Time Frame: Each semester of school in year 1, 2 and 3 of study
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School enrollment, attendance, drop out and grade graduation will be assessed for all children through data extraction from school records.
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Each semester of school in year 1, 2 and 3 of study
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Change in head circumference
Time Frame: After birth, year 1, year 2, year 3
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Children born after the cash transfer progam will have head circumference taken.
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After birth, year 1, year 2, year 3
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Change in Literacy
Time Frame: Year 1, year 2, year 3
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Children 7 and 14 will complete literacy testing.
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Year 1, year 2, year 3
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Change in Grip Strength
Time Frame: Baseline, year 1, year 2 and year 3
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Change in grip strength will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.
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Baseline, year 1, year 2 and year 3
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alfa U Jalo, MS, Ministry of Finance
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1234 (Department of Defense)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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