Food SecurityNCT02526147
WFP Cash, Food, and Voucher Study in Ecuador
A study testing Cash, Voucher and Food in people with Food Security, run by International Food Policy Research Institute.
Trial summary
This evaluation is part of a five country project to evaluate the benefits and costs of the use of two alternatives to food transfers: vouchers and cash (hereafter referred to as "alternative modalities"). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Security
- What is being tested?
- Cash, Voucher and Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,580 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Nov 2011
- 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
- Households in pre-selected neighborhoods in Carchi and Sucumbios with high poverty status according to the proxy means test.
- For hemoglobin measurements, children residing in these households that are 6 months-5 years old, and adolescent girls 10-16 years old
Who cannot join
- Households that receive the Bono de Desarrollo Humano
- Children ages 6 months - 5 years who are severely sick
About this study
This evaluation is part of a five country project to evaluate the benefits and costs of the use of two alternatives to food transfers: vouchers and cash (hereafter referred to as "alternative modalities"). The project will generate information on how outcomes such as household food expenditure and dietary diversity, relevant to both beneficiaries and WFP, change following the introduction of these alternative modalities; how benefits and costs of these are, relative to food transfers, distributed across and within households; and what are the critical operational issues that need to be addressed for these alternatives to be successfully implemented. More specifically, the project will answer seven questions:
- Do households benefit from receipt of the alternative modalities?
- Are these benefits greater, or less, when transfers are made using alternative modalities compared to food transfers. How does this vary across outcomes (such as nutrition, livelihoods, gender dynamics and intra-household resource allocation) that are of especial interest to WFP?
- How does the distribution of benefits differ across households when transfers are made using alternative modalities compared to food transfers?
- How does the distribution of benefits differ within households when transfers are made using alternative modalities compared to food transfers? Do certain household members (women, young children) benefit more from one type of modality? How do these modalities affect decision-making processes within the household?
- Why are these differences observed? How do the reasons for these differences affect the study's ability to generalize from these evaluations?
- Does the delivery of alternative modalities cost less than food transfers? What accounts for these cost differences? Are some costs (such as transport) really lower or are they transferred to beneficiaries? Within the household, who bears these additional costs?
- What is the benefit: cost ratios associated with these different modalities from the perspective of WFP? Is there a conflict between the modality "preferred" by WFP and the modality "preferred" by beneficiaries?
These objectives will be accomplished through household survey data collection among a panel of households before and after transfer of alternative modalities. In addition, select countries will involve the collection of anthropometric, biomarker and cognitive testing.
Read the detailed description
In Ecuador, the intervention consists of food, food vouchers or cash transfers to Colombian refugees and poor Ecuadorian households in four urban and peri-urban areas of Carchi and Sucumbios in northern Ecuador. The transfer is given monthly for 6 months. The program is conditional on attendance at nutrition and community trainings occurring once a month. In most cases the transfer recipient is the female head of household or spouse, however in some cases men may also receive the transfer.
The study is a 2 stage randomized control trial where, first, 80 neighborhoods were randomized to either treatment or control group; second, treatment clusters (geographical units within neighborhoods) were randomized to either: cash, food voucher or food assistance. Approximately 20 - 28 participants from each of the 145 clusters were randomly selected for interviews. In addition to the household socio-economic survey, hemoglobin measures were taken from children between 6 months and 5 years of age and adolescent girls from age 10 to 16 years in each household. The baseline survey occurred in April 2011 and the endline in November 2011.
Interviews were conducted with female heads of households or spouses where possible, or with adult male head of households. In addition, hemoglobin was collected for all children ages 6 months to 5 years and for adolescent girls residing in surveyed households.
- Conditions
- Food Security
- Being tested
- Cash, Voucher, Food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CashOther
VoucherOther
FoodOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receives no intervention |
| Cash | Experimental | Household receives cash transfer monthly for 6 months Receives: Other: Cash |
| Voucher | Experimental | Household receives food voucher to use at local supermarket monthly for 6 months Receives: Other: Voucher |
| Food | Experimental | Household receives food transfer composed of rice, lentils, canned sardines, and vegetable oil, monthly for 6 months Receives: Other: Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food security as measured by the value of food consumption through a household questionnaire
Value of food consumption is a monetary value greater than zero of food consumed in the household in the last week.
Measured: 6 months
Dietary diversity as measured by dietary diversity index and food consumption score through a household questionnaire
Dietary diversity index is the number of food items consumed in the household in the last week. Household questionnaire asks about 41 food items, and thus the index ranges from 0-41.
Food consumption score uses same information from food items consumed in the last week, groups them into 8 food groups (staples, pulses, vegetables, fruit, meat/fish, milk/dairies, sugar/honey, oils/fats), sums the number of days these eight different food groups were consumed, and then weights the different groups according to their nutritional value. The score ranges from 0-112.
Measured: 6 months
Secondary outcomes (2)
Mean hemoglobin level as measured by a portable hemoglobinometer (Hemocue AB, Sweden)
Hemoglobin concentration of whole blood will be determined using a portable hemoglobinometer (Hemocue AB, Sweden); a single drop of whole capillary blood from the tip of the middle or index finger will be transferred to the microcuvette using a glass pipette and results will be recorded to the nearest 1 g/L.
Measured: 6 months
Prevalence of intimate partner violence as measured by WHO Violence Against Woman Instrument
Measures the percent of women who have experienced physical violence, controlling behaviors, or emotional violence.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startApr 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food SecurityStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,580 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- World Food Program
- Responsible party
- Sponsor
- Investigators
- Melissa L Hidrobo, PhD, Principal investigator, IFPRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526147
- Sponsor's protocol ID
- 6119-001
- Status last verified
- Aug 2015
- First submitted
- 12 Aug 2015
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Buller AM, Hidrobo M, Peterman A, Heise L. The way to a man's heart is through his stomach?: a mixed methods study on causal mechanisms through which cash and in-kind food transfers decreased intimate partner violence. BMC Public Health. 2016 Jun 8;16:488. doi: 10.1186/s12889-016-3129-3.
PubMed 27278935
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WFP Cash, Food, and Voucher Study in Ecuador
- ClinicalTrials.gov ID
- NCT02526147
- Acronym / sponsor ID
- 6119-001
- Conditions
- Food Security
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,580 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- World Food Program
- Study start
- Apr 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 18 Aug 2015 (estimated)
- 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 evaluation is part of a five country project to evaluate the benefits and costs of the use of two alternatives to food transfers: vouchers and cash (hereafter referred to as "alternative modalities"). The project will generate information on how outcomes such as household food expenditure and dietary diversity, relevant to both beneficiaries and WFP, change following the introduction of these alternative modalities; how benefits and costs of these are, relative to food transfers, distributed across and within households; and what are the critical operational issues that need to be addressed for these alternatives to be successfully implemented. More specifically, the project will answer seven questions:
- Do households benefit from receipt of the alternative modalities?
- Are these benefits greater, or less, when transfers are made using alternative modalities compared to food transfers. How does this vary across outcomes (such as nutrition, livelihoods, gender dynamics and intra-household resource allocation) that are of especial interest to WFP?
- How does the distribution of benefits differ across households when transfers are made using alternative modalities compared to food transfers?
- How does the distribution of benefits differ within households when transfers are made using alternative modalities compared to food transfers? Do certain household members (women, young children) benefit more from one type of modality? How do these modalities affect decision-making processes within the household?
- Why are these differences observed? How do the reasons for these differences affect the study's ability to generalize from these evaluations?
- Does the delivery of alternative modalities cost less than food transfers? What accounts for these cost differences? Are some costs (such as transport) really lower or are they transferred to beneficiaries? Within the household, who bears these additional costs?
- What is the benefit: cost ratios associated with these different modalities from the perspective of WFP? Is there a conflict between the modality "preferred" by WFP and the modality "preferred" by beneficiaries?
These objectives will be accomplished through household survey data collection among a panel of households before and after transfer of alternative modalities. In addition, select countries will involve the collection of anthropometric, biomarker and cognitive testing.
Detailed description
In Ecuador, the intervention consists of food, food vouchers or cash transfers to Colombian refugees and poor Ecuadorian households in four urban and peri-urban areas of Carchi and Sucumbios in northern Ecuador. The transfer is given monthly for 6 months. The program is conditional on attendance at nutrition and community trainings occurring once a month. In most cases the transfer recipient is the female head of household or spouse, however in some cases men may also receive the transfer.
The study is a 2 stage randomized control trial where, first, 80 neighborhoods were randomized to either treatment or control group; second, treatment clusters (geographical units within neighborhoods) were randomized to either: cash, food voucher or food assistance. Approximately 20 - 28 participants from each of the 145 clusters were randomly selected for interviews. In addition to the household socio-economic survey, hemoglobin measures were taken from children between 6 months and 5 years of age and adolescent girls from age 10 to 16 years in each household. The baseline survey occurred in April 2011 and the endline in November 2011.
Interviews were conducted with female heads of households or spouses where possible, or with adult male head of households. In addition, hemoglobin was collected for all children ages 6 months to 5 years and for adolescent girls residing in surveyed households.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receives no intervention |
| Cash | Experimental | Other: CashHousehold receives cash transfer monthly for 6 months |
| Voucher | Experimental | Other: VoucherHousehold receives food voucher to use at local supermarket monthly for 6 months |
| Food | Experimental | Other: FoodHousehold receives food transfer composed of rice, lentils, canned sardines, and vegetable oil, monthly for 6 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Households in pre-selected neighborhoods in Carchi and Sucumbios with high poverty status according to the proxy means test.
- For hemoglobin measurements, children residing in these households that are 6 months-5 years old, and adolescent girls 10-16 years old
Key exclusion criteria (2 listed)
- Households that receive the Bono de Desarrollo Humano
- Children ages 6 months - 5 years who are severely sick
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 | Other | Cash |
| Voucher | Other | Voucher |
| Food | Other | Food |
Primary outcome
Food security as measured by the value of food consumption through a household questionnaire
Time frame: 6 months
Value of food consumption is a monetary value greater than zero of food consumed in the household in the last week.
Dietary diversity as measured by dietary diversity index and food consumption score through a household questionnaire
Time frame: 6 months
Dietary diversity index is the number of food items consumed in the household in the last week. Household questionnaire asks about 41 food items, and thus the index ranges from 0-41. Food consumption score uses same information from food items consumed in the last week, groups them into 8 food groups (staples, pulses, vegetables, fruit, meat/fish, milk/dairies, sugar/honey, oils/fats), sums the number of days these eight different food groups were consumed, and then weights the different groups according to their nutritional value. The score ranges from 0-112.
2 secondary outcomes
Mean hemoglobin level as measured by a portable hemoglobinometer (Hemocue AB, Sweden)
Time frame: 6 months
Prevalence of intimate partner violence as measured by WHO Violence Against Woman Instrument
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Derived from this study: PubMed 27278935Buller AM, Hidrobo M, Peterman A, Heise L. The way to a man's heart is through his stomach?: a mixed methods study on causal mechanisms through which cash and in-kind food transfers decreased intimate partner violence. BMC Public Health. 2016 Jun 8;16:488. doi: 10.1186/s12889-016-3129-3.
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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.
Melissa L Hidrobo, PhD principal investigator
IFPRI
Questions about this trial
What is this clinical trial studying?
A study testing Cash, Voucher and Food in people with Food Security, run by International Food Policy Research Institute.
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 2 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: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Food security as measured by the value of food consumption through a household questionnaire (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526147, which also lists 1 linked publication.
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 25 Aug 2015.