Per Capita Food Consumption ExpenditureNCT03455257
Evaluation of a Cash Transfer Program in Low-Income Families in Guinea-Bissau
A study testing Cash Transfer in people with Per Capita Food Consumption Expenditure and Childhood Growth, run by Ministry of Finance, Guinea-Bissau at 1 site in Guinea-Bissau.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Per Capita Food Consumption Expenditure, Childhood Growth, Childhood Cognition
- What is being tested?
- Cash Transfer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34,148 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- 25 Apr 2017to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Families with high scores on asset scale.
- Families uninterested in participating.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Per Capita Food Consumption Expenditure, Childhood Growth, Childhood Cognition, Anemia, School Registration and Attendence, Diabetes
- Being tested
- Cash Transfer
- Medical subject headings
- Anemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cash TransferBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Families assigned to this arm will be assessment only controls that do not receive the cash transfer. |
| Intervention | Experimental | 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. Receives: Behavioral: Cash Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in per capita food expeditures
change in per capita food expenditure per family will be calculated.
Measured: Baseline, year 1, year 2 and year 3
Secondary outcomes (14)
Changes in family demographics
Changes in family demographics will be tracked.
Measured: Baseline, year 1, year 2 and year 3
Change in weight
Change in weight for all participants in the study and children born after cash transfer program starts.
Measured: Baseline, year 1, year 2 and year 3
Change in height
Change in height for all participants in the study and children born after cash transfer program starts.
Measured: Baseline, year 1, year 2 and year 3
Change in mid-upper arm circumference (MUAC)
Change in MUAC for all participants in the study and children born after cash transfer program starts.
Measured: Baseline, year 1, year 2 and year 3
Change in waist circumference
Change in waist circumference for all participants in the study and children born after cash transfer program starts.
Measured: Baseline, year 1, year 2 and year 3
Change in hemoglobin
Change in hemoglobin for pregnant women, children born after the program begins, older children born in 2003, 2010, 2014.
Measured: Baseline, year 1, year 2 and year 3
Change in blood pressure
Change in blood pressure will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.
Measured: Baseline, year 1, year 2 and year 3
Change in HbA1c
Change in HbA1c will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.
Measured: Baseline, year 1, year 2 and year 3
Food intake
Food intake assessment
Measured: Year 1, year 2 and year 3
Cognition function
Children born after the cash transfer progam will have a single cognitive function test at 18 months of age.
Measured: When children are 18th months
Change in school attendence
School enrollment, attendance, drop out and grade graduation will be assessed for all children through data extraction from school records.
Measured: Each semester of school in year 1, 2 and 3 of study
Change in head circumference
Children born after the cash transfer progam will have head circumference taken.
Measured: After birth, year 1, year 2, year 3
Change in Literacy
Children 7 and 14 will complete literacy testing.
Measured: Year 1, year 2, year 3
Change in Grip Strength
Change in grip strength will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.
Measured: Baseline, year 1, year 2 and year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start25 Apr 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Per Capita Food Consumption ExpenditureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating families are randomized into one of two groups, an assessment-only controls group or a cash transfer group.
- Masking
- None (open label)
- Enrolment
- 34,148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Finance, Guinea-Bissau
- Sponsor type
- Other government
- Collaborators
- International Partnership for Human Development, National Institute of Statistics (INE), World Bank
- Responsible party
- Sponsor
- Investigators
- Alfa U Jalo, MS, Principal investigator, Ministry of Finance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455257
- Sponsor's protocol ID
- 1234
- Status last verified
- Feb 2018
- First submitted
- 21 Feb 2018
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Cash Transfer Program in Low-Income Families in Guinea-Bissau
- ClinicalTrials.gov ID
- NCT03455257
- Acronym / sponsor ID
- 1234
- Conditions
- Per Capita Food Consumption Expenditure, Childhood Growth, Childhood Cognition, Anemia, School Registration and Attendence, Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34,148 participants (estimated)
- Lead sponsor
- Ministry of Finance, Guinea-BissauOther government
- Collaborators
- International Partnership for Human Development, National Institute of Statistics (INE), World Bank
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participating families are randomized into one of two groups, an assessment-only controls group or a cash transfer group.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Families assigned to this arm will be assessment only controls that do not receive the cash transfer. |
| Intervention | Experimental | Behavioral: Cash TransferFamilies 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Families with high scores on asset scale.
- Families uninterested in participating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cash TransferThe 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. | Behavioural | Intervention |
Primary outcome
Change in per capita food expeditures
Time frame: Baseline, year 1, year 2 and year 3
change in per capita food expenditure per family will be calculated.
14 secondary outcomes
Changes in family demographics
Time frame: Baseline, year 1, year 2 and year 3
Change in weight
Time frame: Baseline, year 1, year 2 and year 3
Change in height
Time frame: Baseline, year 1, year 2 and year 3
Change in mid-upper arm circumference (MUAC)
Time frame: Baseline, year 1, year 2 and year 3
Change in waist circumference
Time frame: Baseline, year 1, year 2 and year 3
Change in hemoglobin
Time frame: Baseline, year 1, year 2 and year 3
Change in blood pressure
Time frame: Baseline, year 1, year 2 and year 3
Change in HbA1c
Time frame: Baseline, year 1, year 2 and year 3
Food intake
Time frame: Year 1, year 2 and year 3
Cognition function
Time frame: When children are 18th months
Change in school attendence
Time frame: Each semester of school in year 1, 2 and 3 of study
Change in head circumference
Time frame: After birth, year 1, year 2, year 3
Change in Literacy
Time frame: Year 1, year 2, year 3
Change in Grip Strength
Time frame: Baseline, year 1, year 2 and year 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfa U Jalo, MS principal investigator
Ministry of Finance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cash Transfer in people with Per Capita Food Consumption Expenditure and Childhood Growth, run by Ministry of Finance, Guinea-Bissau at 1 site in Guinea-Bissau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in per capita food expeditures (time frame: Baseline, year 1, year 2 and year 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.