ISRCTN ISRCTN12225603
DOI https://doi.org/10.1186/ISRCTN12225603
Submission date
27/10/2023
Registration date
01/11/2023
Last edited
27/08/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
Even before the onset of the current civil war, Yemen was one of the poorest countries in the world ranking 183 out of 191 countries and territories on the UN Human Development Index. The World Food Programme (WFP) estimates that currently 17 million Yemeni (half the population) are food insecure and 2.2 million preschool children are acutely malnourished (World Food Programme, 2023a). In 2022, 17% of school children in Yemen received school meals (WFP, 2022) and in 2023, the humanitarian response will cover only 8% of the needs of education sector, leaving it with the second highest unmet need (OCHA, 2023). WFP provides nutritious snacks (imported or locally procured), either fortified date bars or fortified high energy biscuits, to 1.55 million school children. There is an urgent need to understand how to improve access to nutritious school meals to support students and schools throughout the country. The aim of this study is to evaulate the effectiveness and cost-efficacy of adding a daily drink of milk to an ongoing school feeding program to improve children's diet.

Who can participate?
Children 6-8 years of age attending one of the schools included in the study

What does the study involve?
Schools will be randomly allocated to one of two groups to receive:
1. Standard of care: the standard WFP school feeding program involving daily distribtuion of high energy biscuits
2. The standard of care intervention with addition of a daily drink of milk
The intervention lasts approximately one school year (~7 months).

What are the possible benefits and risks of participating?
The intervention is expected to improve children's diets, cognition, learning scores, and nutritional status by providing additional protein and micronutritients through the milk distribution in addition to the high energy buscuits. The intervention is also expect to improve children's attendance and caregivers perceptions and willingness to pay for school meals. There are no known risks related to the intervention involved.

Where is the study run from?
International Food Policy Research Institute (USA, Egypt)

When is the study starting and how long is it expected to run for?
August 2023 to July 2024

Who is funding the study?
1. CGIAR Initiative on Fragility, Conflict, and Migration (USA)
2. HSA Group (USA)

Who is the main contact?
Dr Aulo Gelli, A.Gelli@cgiar.org

Contact information

Dr Aullo Gelli
Public, Scientific, Principal Investigator

1201 Eye Street NW
Washington
20005
United States of America

Phone +1 202-862-5600
Email a.gelli@cgiar.org

Study information

Study designLongitudinal cluster-randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleImpact evaluation of an added milk intervention to a micronutrient fortified school feeding program: An effectiveness pilot trial in Yemen
Study hypothesisThe study will evaluate the cost, cost-efficiency and impact of adding a daily drink of milk to an ongoing school feeding program. The hypothesis is that the addition of milk will improve school-aged children's diet, nutrition, health, and education outcomes.
Ethics approval(s)

Approved 28/09/2023, International Food Policy Research Institute (1201 Eye Street NW, Washington, 20005, United States of America; +1 (202) 862-5600; IFPRI-IRB@cgiar.org), ref: NDH-23-0942

ConditionImprovement of dietary diversity in primary school-aged children
Intervention1. Control - standard of care school feeding program which involves the distribution of high-energy biscuits
2. Intervention - standard of care school feeding program consisting of the distribution of high-energy biscuits plus distribution of 100 ml cartons of ultra high temperature (UHT) milk

The total duration of the intervention will be ~7 months from November 2023 to May 2024. Both study arms will be followed-up for ~7 months and interviewed at baseline and follow-up.

Schools were randomly assigned to intervention and control in Stata 18, stratifying by school size.
Intervention typeOther
Primary outcome measureDiet diversity score in children 6-8 years of age, measured using the Minimum dietary diversity for women (MDD-W) guidelines at baseline and endline
Secondary outcome measures1. Cognition in children 6-8 years of age, measured using the forward and backward digit span and the standard progressive matrices at baseline and endline
2. Learning in children 6-8 years of age, measured using literacy and numeracy scores at baseline and endline
3. Nutritional status, measuring using body mass index and height-for-age Z-score at baseline and endline
4. School attendance, measured using school observations at baseline and endline
5. Perceptions of school feading program, measured using caregiver self-report at baseline and endline
6. Child health, measured using caregiver report of child morbidity symptoms at baseline and endline
Overall study start date01/08/2023
Overall study end date31/07/2024

Eligibility

Participant type(s)Learner/student
Age groupMixed
Lower age limit6 Years
Upper age limit100 Years
SexBoth
Target number of participants1,200
Total final enrolment1299
Participant inclusion criteria1. Children aged 6-8 years at baseline enrolled in schools involved in the study
2. Adult caregivers (≥18 years of age) of children aged 6-8 included in the study
Participant exclusion criteriaHousehold head, child, parent or guardian unwilling to participate in the study
Recruitment start date04/11/2023
Recruitment end date30/11/2023

Locations

Countries of recruitment

  • United States of America
  • Yemen

Study participating centre

International Food Policy Research Institute
1201 Eye Street NW
Washington
20005
United States of America

Sponsor information

International Food Policy Research Institute
Research organisation

1201 Eye Street NW
Washington, DC
20005
United States of America

Phone +1 202-862-5600
Email ifpri@cgiar.org
Website https://www.ifpri.org/
ROR logo "ROR" https://ror.org/03pxz9p87

Funders

Funder type

Research organisation

International Food Policy Research Institute

No information available

HSA Group

No information available

Results and Publications

Intention to publish date31/07/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from a.gelli@cgiar.org

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 22/05/2024 No No
Statistical Analysis Plan 27/08/2024 27/08/2024 No No

Additional files

ISRCTN12225603_PROTOCOL.pdf
ISRCTN12225603_SAP_27Aug24.pdf

Editorial Notes

27/08/2024: Statistical analysis plan added.
22/05/2024: Protocol and total final enrolment added.
31/10/2023: Trial's existence confirmed by International Food Policy Research Institute.