Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Janet Cade


Contact details

Nutritional Epidemiology Group
Centre for Epidemiology and Biostatistics
University of Leeds
30-32 Hyde Terrace
United Kingdom
+44 (0)1133 436946

Additional identifiers

EudraCT number number

Protocol/serial number

FSA N14R0004

Study information

Scientific title


Study hypothesis

The use of a ‘smart’ lunchbox approach is more effective in improving healthy food consumption in primary school children at lunchtime, than providing a healthy eating leaflet alone.

Ethics approval

University of Leeds. Date of approval:26/10/06 (ref: 1706)

Study design

Cluster randomised controlled trial (randomised by schools)

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Not Specified

Patient information sheet




Randomisation: The schools in England were stratified to tertiles according to the percentage of pupils in the school eligible for free school meals, and quintiles according to the key stage 2 Standard Assessment Tests (SATs) exam results (percentage of pupils reaching level 4 in mathematics, English and science). These are approximate measures of deprivation of the catchments area of the school. Stratification ensured that the intervention and control groups contained equal numbers of schools at different levels of both factors.

Intervention materials were devised according to best practice and the results of an earlier video ethnography study. In that preliminary study, parents were videoed about their choices of food for their children’s lunchboxes. The intervention group in this study received a ‘smart’ lunchbox template and associated materials and activities (the ‘smart’ lunchbox approach) to provide an aid to parents for shopping for lunchbox food and preparation, and encouragement to children to adopt healthier eating patterns. The template itself is a physical resource (a lunchbox), with different compartments containing information and pictures about the choices open to parents. This template has been developed in collaboration with organisations involved in designing, developing and producing new food packaging materials (e.g. Faraday Packaging Partnership and Design Futures). The collaborative approach has ensured that the expertise of relevant parties from academia and industry can be capitalised on throughout the development phase.

The template aimed to support healthier lunchbox preparation in three ways:
1. Support at the point of food shopping
2. Support during lunchbox preparation at home
3. Support for the child at school lunch to encourage eating the healthier lunch

The template was based on the ‘Balance of Good Health’ to guide parents regarding the balance to be aimed at in preparation of a lunchbox. Parents and children also received supporting materials such as magnets, shopping bags, drink bottles, stickers, games, healthy eating information, the School Foods Trust leaflet on packed lunches and ideas for three weeks of packed lunchboxes. In combination this is known as ‘the smart lunchbox approach’.

The control group received the School Foods Trust leaflet.

Intervention type



Not Specified

Drug names

Primary outcome measures

1. Nutritional and food based measurements indicating improvements in the contents of lunch boxes
2. Levels of macronutrients:
2.1. Fat
2.2. Sugar
2.3. Energy
2.4. Protein
2.5. Sodium
3. Food types (e.g. sandwiches, savoury snacks, confectionery, dairy)

The outcomes above will be assessed by the following:
1. A questionnaire in June 2006 (baseline) and an identical follow up questionnaire repeated in June 2007
2. All food in the lunch box was weighed before and after lunch to measure the amount of food consumed and left over

Secondary outcome measures

Micronutrients (e.g. iron, zinc, vitamin A) assessed by:
1. Weighing each food item in the lunch box before and after lunch to measure the amount of food consumed and left over, as for primary outcome measures
2. Questionnaire in June 2006 (baseline) and an identical follow up questionnaire repeated in June 2007, as for primary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

All primary schools in England, Wales, Scotland and Northern Ireland were eligible for inclusion in the study, All children in Year 4 (8 to 9 years old) of participating schools who bring in a packed lunch were eligible for inclusion in the study.

Participant type


Age group




Target number of participants


Participant exclusion criteria

Primary schools involved in another healthy eating study (the evaluation of the National School Fruit Scheme).

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Nutritional Epidemiology Group
United Kingdom

Sponsor information


Food Standards Agency (UK)

Sponsor details

Aviation house
125 Kingsway
United Kingdom
+44 (0)20 7276 8936

Sponsor type




Funder type


Funder name

Food Standards Agency (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in

Publication citations

  1. Results

    Evans CE, Greenwood DC, Thomas JD, Cleghorn CL, Kitchen MS, Cade JE, SMART lunch box intervention to improve the food and nutrient content of children's packed lunches: UK wide cluster randomised controlled trial., J Epidemiol Community Health, 2010, 64, 11, 970-976, doi: 10.1136/jech.2008.085837.

Additional files

Editorial Notes