Impact Evaluation of WFP's Fresh Food Voucher Pilot Programme in Ethiopia

February 25, 2019 updated by: Kalle Hirvonen, International Food Policy Research Institute
To assess the impact of WFP's Fresh Food Voucher Pilot Programme in Ethiopia on children's and mother's diets

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
574

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Ababa, Ethiopia, 00000
        • Kalle Hirvonen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Households with young children aged 6-17 months age at the baseline in December 2017.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: BCC-Only
Intervention: Households in the 'BCC-only' arm receive SBCC but do not receive vouchers.
Behavioral: BCC-Only
Households in the 'BCC-only' arm receive SBCC but do not receive vouchers.
Experimental: Small-voucher
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.
Other: Small-voucher
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.
Experimental: Large-voucher
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.
Other: Large-voucher
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Minimum Acceptable Diet Scores (MAD) of children 6-23 months of age
Time Frame: 12 months
Change in the proportion of children achieving MAD
12 months
Minimum diet diversity (MDD-W) for women of reproductive age
Time Frame: 12 months
Change in the proportion of women achieving MDD-W
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Minimum Diet Diversity (MDD) of children 6-23 months of age
Time Frame: 12 months
Change in the proportion of children achieving MDD
12 months
Minimum Meal Frequency (MFF) of children 6-23 months of age
Time Frame: 12 months
Change in the proportion of children achieving MFF
12 months
Household Diet Diversity Score (HDDS)
Time Frame: 12 months
Mean difference in HDDS
12 months
WFP Food Consumption Score- Nutrition
Time Frame: 12 months
Mean difference in WFP Food Consumption Score- Nutrition
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Food Policy Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United Nations World Food Programme (WFP)
Addis Ababa University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kalle Hirvonen, PhD, International Food Policy Research Institute, Ethiopia
  • Principal Investigator: Kaleab Baye, PhD, Center for Food Science and Nutrition, Addis Ababa University, Ethiopia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 699013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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