Diet; DeficiencyNCT03590717
Impact Evaluation of WFP's Fresh Food Voucher Pilot Programme in Ethiopia
A study testing BCC-Only, Small-voucher and Large-voucher in people with Diet; Deficiency and Malnutrition, run by International Food Policy Research Institute at 1 site in Ethiopia.
Trial summary
To assess the impact of WFP's Fresh Food Voucher Pilot Programme in Ethiopia on children's and mother's diets Read more about this study
- Who is it for?
- Ages 6 to 17 monthsHealthy volunteers can take part
- Conditions the study is for
- Diet; Deficiency, Malnutrition
- What is being tested?
- BCC-Only, Small-voucher and Large-voucher
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 574 participants
- Where
- 1 siteEthiopia
- Study dates
- 27 Jun 2018to 31 Dec 2018
- 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 6 to 17 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Households with young children aged 6-17 months age at the baseline in December 2017.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the impact of WFP's Fresh Food Voucher Pilot Programme in Ethiopia on children's and mother's diets
Read the detailed description
Rationale: Infants, young children and adult women in rural Ethiopia consume one of the least diversified diets in the world. The World Food Programme's Fresh Food Voucher (FFV) Pilot Programme aims to improve dietary diversity among infants and young children and their mothers. The focus on these demographic groups is based on the now well-established theory on the importance of the 'first 1,000 days'. This period, spanning the pregnancy and the first 2 years of child's life, is considered critical for child's physical growth and cognitive development. The beneficiary households receive a voucher that can be used to purchase fresh foods (fruits, vegetables and certain animal source foods).
Objective: The main objectives of the evaluation are to assess and report on the performance and results of the FFV programme to help WFP present high-quality and credible evidence of actual impact to its donors. In addition, the evaluation will determine the reasons why certain results occurred (or not) to draw lessons, derive good practices and pointers for learning.
Study design: This is a mixed methods evaluation that combines a Randomized Controlled Trial (RCT) with Focus Group Discussions (FGDs) with caregivers and food traders. The RCT contains three arms. The first treatment arm receives a smaller voucher (roughly $12-17) and social behavioural change communication (SBCC). The second treatment arm receives a larger voucher (roughly $21-23) and SBCC. Households in the third study arm (control) receive SBCC but do not receive vouchers. A cluster in this impact evaluation is defined as a village (got in Amharic) and these clusters of are randomly allocated to the different arms of the trial. Within a cluster, all eligible households will receive the same treatment.
Study population: All households with a child between 6-17 months at the baseline in December 2017 were eligible to be included in the quantitative sample.
Main study parameters/endpoints: The main outcomes of interest are minimum acceptable diet score for children 6- 23 months (World Health Organization, 2008) and minimum diet diversity for women of reproductive age (FAO \& FHI-360, 2016).
- Conditions
- Diet; Deficiency, Malnutrition
- Being tested
- BCC-Only, Small-voucher, Large-voucher
- Keywords
- dietary diversity, minimum acceptable diet, fruits, vegetables, animal sourced foods
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCC-OnlyBehavioural
Households in the 'BCC-only' arm receive SBCC but do not receive vouchers.
Small-voucherOther
Households in the 'Small-voucher' arm receive a voucher (~$12-17) every month that entitles them to purchase fresh foods (fruits, vegetables and animal sourced foods). The households in this arm also receive the same social behavioural change communication (SBCC) messages as the 'BCC-only' arm.
Large-voucherOther
Households in the 'Large-voucher' arm receive a larger voucher (~$21-23) every month that entitles them to purchase fresh foods (fruits, vegetables and animal sourced foods). The households in this arm also receive the same social behavioural change communication (SBCC) messages as the 'BCC-only' arm.
| Study group | Role | What they receive |
|---|---|---|
| BCC-Only | Other | Intervention: Households in the 'BCC-only' arm receive SBCC but do not receive vouchers. Receives: Behavioral: BCC-Only |
| Small-voucher | Experimental | Intervention: Households in the 'Small-voucher' arm receive a voucher (~$12-17) every month that entitles them to purchase fresh foods (fruits, vegetables and animal sourced foods). The households in this arm also receive the same social behavioural change communication (SBCC) messages as the 'BCC-only' arm. Receives: Other: Small-voucher |
| Large-voucher | Experimental | Intervention: Households in the 'Large-voucher' arm receive a larger voucher (~$21-23) every month that entitles them to purchase fresh foods (fruits, vegetables and animal sourced foods). The households in this arm also receive the same social behavioural change communication (SBCC) messages as the 'BCC-only' arm. Receives: Other: Large-voucher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Acceptable Diet Scores (MAD) of children 6-23 months of age
Change in the proportion of children achieving MAD
Measured: 12 months
Minimum diet diversity (MDD-W) for women of reproductive age
Change in the proportion of women achieving MDD-W
Measured: 12 months
Secondary outcomes (4)
Minimum Diet Diversity (MDD) of children 6-23 months of age
Change in the proportion of children achieving MDD
Measured: 12 months
Minimum Meal Frequency (MFF) of children 6-23 months of age
Change in the proportion of children achieving MFF
Measured: 12 months
Household Diet Diversity Score (HDDS)
Mean difference in HDDS
Measured: 12 months
WFP Food Consumption Score- Nutrition
Mean difference in WFP Food Consumption Score- Nutrition
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start27 Jun 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet; DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Cluster randomized controlled trial clustered at the village level, 2 treatment arms and one control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Ababa University, United Nations World Food Programme (WFP)
- Responsible party
- Principal investigator, Kalle Hirvonen, International Food Policy Research Institute
- Investigators
- Kalle Hirvonen, PhD, Principal investigator, International Food Policy Research Institute, EthiopiaKaleab Baye, PhD, Principal investigator, Center for Food Science and Nutrition, Addis Ababa University, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590717
- Sponsor's protocol ID
- 699013
- Status last verified
- Feb 2019
- First submitted
- 6 Jul 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of WFP's Fresh Food Voucher Pilot Programme in Ethiopia
- ClinicalTrials.gov ID
- NCT03590717
- Acronym / sponsor ID
- 699013
- Conditions
- Diet; Deficiency, Malnutrition
- Keywords
- dietary diversity, minimum acceptable diet, fruits, vegetables, animal sourced foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Addis Ababa University, United Nations World Food Programme (WFP)
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 18 Jul 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.
To assess the impact of WFP's Fresh Food Voucher Pilot Programme in Ethiopia on children's and mother's diets
Detailed description
Rationale: Infants, young children and adult women in rural Ethiopia consume one of the least diversified diets in the world. The World Food Programme's Fresh Food Voucher (FFV) Pilot Programme aims to improve dietary diversity among infants and young children and their mothers. The focus on these demographic groups is based on the now well-established theory on the importance of the 'first 1,000 days'. This period, spanning the pregnancy and the first 2 years of child's life, is considered critical for child's physical growth and cognitive development. The beneficiary households receive a voucher that can be used to purchase fresh foods (fruits, vegetables and certain animal source foods).
Objective: The main objectives of the evaluation are to assess and report on the performance and results of the FFV programme to help WFP present high-quality and credible evidence of actual impact to its donors. In addition, the evaluation will determine the reasons why certain results occurred (or not) to draw lessons, derive good practices and pointers for learning.
Study design: This is a mixed methods evaluation that combines a Randomized Controlled Trial (RCT) with Focus Group Discussions (FGDs) with caregivers and food traders. The RCT contains three arms. The first treatment arm receives a smaller voucher (roughly $12-17) and social behavioural change communication (SBCC). The second treatment arm receives a larger voucher (roughly $21-23) and SBCC. Households in the third study arm (control) receive SBCC but do not receive vouchers. A cluster in this impact evaluation is defined as a village (got in Amharic) and these clusters of are randomly allocated to the different arms of the trial. Within a cluster, all eligible households will receive the same treatment.
Study population: All households with a child between 6-17 months at the baseline in December 2017 were eligible to be included in the quantitative sample.
Main study parameters/endpoints: The main outcomes of interest are minimum acceptable diet score for children 6- 23 months (World Health Organization, 2008) and minimum diet diversity for women of reproductive age (FAO \& FHI-360, 2016).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Cluster randomized controlled trial clustered at the village level, 2 treatment arms and one control group.
| Arm | Type | Receives |
|---|---|---|
| BCC-Only | Other | Behavioral: BCC-OnlyIntervention: Households in the 'BCC-only' arm receive SBCC but do not receive vouchers. |
| Small-voucher | Experimental | Other: Small-voucherIntervention: Households in the 'Small-voucher' arm receive a voucher (~$12-17) every month that entitles them to purchase fresh foods (fruits, vegetables and animal sourced foods). The households in this arm also receive the same social behavioural change communication (SBCC) messages as the 'BCC-only' arm. |
| Large-voucher | Experimental | Other: Large-voucherIntervention: Households in the 'Large-voucher' arm receive a larger voucher (~$21-23) every month that entitles them to purchase fresh foods (fruits, vegetables and animal sourced foods). The households in this arm also receive the same social behavioural change communication (SBCC) messages as the 'BCC-only' arm. |
Who may qualify
- Ages
- 6 to 17 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Households with young children aged 6-17 months age at the baseline in December 2017.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BCC-OnlyHouseholds in the 'BCC-only' arm receive SBCC but do not receive vouchers. | Behavioural | BCC-Only |
| Small-voucherHouseholds in the 'Small-voucher' arm receive a voucher (~$12-17) every month that entitles them to purchase fresh foods (fruits, vegetables and animal sourced foods). The households in this arm also receive the same social behavioural change communication (SBCC) messages as the 'BCC-only' arm. | Other | Small-voucher |
| Large-voucherHouseholds in the 'Large-voucher' arm receive a larger voucher (~$21-23) every month that entitles them to purchase fresh foods (fruits, vegetables and animal sourced foods). The households in this arm also receive the same social behavioural change communication (SBCC) messages as the 'BCC-only' arm. | Other | Large-voucher |
Primary outcome
Minimum Acceptable Diet Scores (MAD) of children 6-23 months of age
Time frame: 12 months
Change in the proportion of children achieving MAD
Minimum diet diversity (MDD-W) for women of reproductive age
Time frame: 12 months
Change in the proportion of women achieving MDD-W
4 secondary outcomes
Minimum Diet Diversity (MDD) of children 6-23 months of age
Time frame: 12 months
Minimum Meal Frequency (MFF) of children 6-23 months of age
Time frame: 12 months
Household Diet Diversity Score (HDDS)
Time frame: 12 months
WFP Food Consumption Score- Nutrition
Time frame: 12 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 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Kalle Hirvonen, PhD principal investigator
International Food Policy Research Institute, Ethiopia
Kaleab Baye, PhD principal investigator
Center for Food Science and Nutrition, Addis Ababa University, Ethiopia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCC-Only, Small-voucher and Large-voucher in people with Diet; Deficiency and Malnutrition, run by International Food Policy Research Institute at 1 site in Ethiopia.
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 1 inclusion and 0 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 26 Feb 2019. 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 Ethiopia. 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?
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?
Minimum Acceptable Diet Scores (MAD) of children 6-23 months of age (time frame: 12 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?
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 26 Feb 2019.