Condition category
Not Applicable
Date applied
25/09/2018
Date assigned
22/10/2018
Last edited
02/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Palestinian refugee children in Lebanon attend schools run by the UN Relief Works Agency for Palestine Refugees (UNRWA). Most schools have a small private food seller selling packaged foods inside the school, with products generally high in fat, sugar and salt. The aim of this study was to investigate the effect of the offering of a subsidised healthy daily school meal at these schools on diet diversity, nutritional status, school attendance and school performance of children.

Who can participate?
Children aged 6 years or older, attending one of four selected elementary schools in two Palestinian camps in Beirut. Children were asked to declare any food allergies they may have in advance of participation.

What does the study involve?
Children attending two intervention schools were offered the option of purchasing a subsidised healthy school meal on a daily basis, in addition to receiving nutrition and health education sessions. Children attending two control schools were offered nutrition and health education sessions only.

What are the possible benefits and risks of participating?
Possible benefits of participating include a potentially improved school meal, and therefore nutrition for children. There are no known risks to participants taking part in this study. Risks of food-borne illness were mitigated by ensuring rigorous food safety standards for the program. Risks of allergies were mitigated by ensuring that children declared allergies in advance.

Where is the study run from?
The study is run from the Center for Research on Population and Health at the American University of Beirut and four schools in two Palestinian camps in Lebanon will participate

When is the study starting and how long is it expected to run for?
September 2013 to December 2017

Who is funding the study?
The Nestle Foundation for the Study of Problems of Nutrition in the World (Switzerland)

Who is the main contact?
Dr Hala Ghattas
hg15@aub.edu.lb

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hala Ghattas

ORCID ID

Contact details

American University of Beirut
PO Box 11-0236/EPHD
Riad El Solh
Beirut
1107 2020
Lebanon
+961 1 350 000 Ext 4679
hg15@aub.edu.lb

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A 102829 -P 22047

Study information

Scientific title

Healthy Kitchens, Healthy Children: a community-based intervention linking community kitchens to a school food program - the Healthy Children component

Acronym

Healthy Kitchens, Healthy Children- Children's study (HKHC-C)

Study hypothesis

This study aimed to investigate the effect of a two-pronged intervention that employed women through social enterprises (Healthy Kitchens) to deliver a subsidised healthy daily school meal to elementary schoolchildren in Palestinian camps (Healthy Children).

We hypothesised that children participating in the Healthy children component of the intervention would have improved dietary diversity, nutritional status, school absenteeism and educational achievements.

Ethics approval

1. American University of Beirut Social and Behavioral Sciences Institutional Review Board (AUB
SBS IRB), 20/12/2013, ref: FHS.HG.01 / FHS.HG.02
2. University of Maryland Institutional Review Board (UMD IRB), 02/12/2013, ref: 535188-1

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Schools

Trial type

Other

Patient information sheet

Not available in web format, please contact Hala Ghattas (hg15@aub.edu.lb) to request a participant information sheet

Condition

Children's diet diversity and nutritional status

Intervention

This study, Healthy Children, is a component of a wider study called Healthy Kitchens, Healthy Children.
The Healthy Schools component is an 8 month, non-randomised school-based intervention, where 2 schools are allocated to receive the intervention and 2 neighbouring schools are allocated to the control group. Intervention schools received a series of 4 interactive health and nutrition classes, and a daily health subsidised snack, made by the women in the Healthy Kitchens component (covering 15% of children's energy requirements and over 30% of iron, folate and Vitamin A requirements), which children purchased at a cost of 0.25 USD/day. Children in the control group received the 4 interactive health and nutrition classes only.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Schoolchildren’s diet diversity assessed using the Diet Diversity Score (DDS) at the baseline and
after 8 months

Secondary outcome measures

The following are assessed at the baseline and after 8 months:
1. Nutritional status, assessed by measuring height and weight and recording age and calculating
indices such as height-for-age Z-score and BMI-for-age Z-score
2. Haemoglobin, assessed using a Hemocue
3. School absence, assessed by the number of school days missed between the baseline and the
end of the study
4. Educational outcomes, including final language and maths grades

Overall trial start date

01/09/2013

Overall trial end date

01/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Child aged over 6 years
2. Registered student in one of four specified UNRWA schools

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

Between 1200-1500 (at least 300 children in each school)

Participant exclusion criteria

None - children were asked to declare any food allergies they might have

Recruitment start date

04/06/2014

Recruitment end date

31/05/2016

Locations

Countries of recruitment

Lebanon

Trial participating centre

Center for Research on Population and Health
Faculty of Health Sciences American University of Beirut Bliss Street Hamra
Beirut
1107 2020
Lebanon

Sponsor information

Organisation

The Nestle Foundation for the Study of Problems of Nutrition in the World

Sponsor details

Place de la Gare 4 - PO Box 581
Lausanne
CH-1001
Switzerland

Sponsor type

Research organisation

Website

http://www.nestlefoundation.org/e/about.html

Funders

Funder type

Research organisation

Funder name

The Nestle Foundation for the Study of Problems of Nutrition in the World

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Data and results of the study have been presented at four conferences; some resulting in
published abstracts.
We have prepared the following for publication:
1. Presenting the protocol and process evaluation of the intervention
2. Presenting the outcomes of the Healthy Children (children's component) of the study
3. Using data from the study, we validated a child food security tool

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to the fact that studies were conducted with vulnerable refugee populations, and data transfer agreements with the collaborating organisations restrict our ability to share these data with third parties.

Intention to publish date

01/01/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2017 results presented at 21st International Congress of Nutrition 2017 https://www.karger.com/Article/Abstract/480486
2017 results presented at Experimental Biology, Chicago, 2017 https://www.fasebj.org/doi/abs/10.1096/fasebj.31.1_supplement.297.2

Publication citations

Additional files

Editorial Notes

02/11/2018: Internal review.