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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03590717
Other study ID # 699013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2018
Est. completion date December 31, 2018

Study information

Verified date February 2019
Source International Food Policy Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the impact of WFP's Fresh Food Voucher Pilot Programme in Ethiopia on children's and mother's diets


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).


Recruitment information / eligibility

Status Completed
Enrollment 574
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 17 Months
Eligibility Inclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BCC-Only
Households in the 'BCC-only' arm receive SBCC but do not receive vouchers.
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.
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.

Locations

Country Name City State
Ethiopia Kalle Hirvonen Addis Ababa

Sponsors (3)

Lead Sponsor Collaborator
International Food Policy Research Institute Addis Ababa University, United Nations World Food Programme (WFP)

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minimum Acceptable Diet Scores (MAD) of children 6-23 months of age Change in the proportion of children achieving MAD 12 months
Primary Minimum diet diversity (MDD-W) for women of reproductive age Change in the proportion of women achieving MDD-W 12 months
Secondary Minimum Diet Diversity (MDD) of children 6-23 months of age Change in the proportion of children achieving MDD 12 months
Secondary Minimum Meal Frequency (MFF) of children 6-23 months of age Change in the proportion of children achieving MFF 12 months
Secondary Household Diet Diversity Score (HDDS) Mean difference in HDDS 12 months
Secondary WFP Food Consumption Score- Nutrition Mean difference in WFP Food Consumption Score- Nutrition 12 months
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