A cluster randomised controlled trial of a lunchbox template, designed to improve the content of lunchboxes in primary school children in the UK

ISRCTN	ISRCTN77710993
DOI	https://doi.org/10.1186/ISRCTN77710993
Protocol serial number	FSA N14R0004
Sponsor	Food Standards Agency (UK)
Funder	Food Standards Agency (UK)

Submission date: 09/05/2007
Registration date: 27/09/2007
Last edited: 30/10/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Janet Cade
Scientific

Nutritional Epidemiology Group
Centre for Epidemiology and Biostatistics
University of Leeds
30-32 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Phone	+44 (0)1133 436946
Email	j.e.cade@leeds.ac.uk

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial (randomised by schools)
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	University of Leeds. Date of approval:26/10/06 (ref: 1706)
Health condition(s) or problem(s) studied	Nutrition
Intervention	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 childrens 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	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	9 Years
Sex	All
Target sample size at registration	600
Key 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.
Key exclusion criteria	Primary schools involved in another healthy eating study (the evaluation of the National School Fruit Scheme).
Date of first enrolment	01/06/2006
Date of final enrolment	30/06/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Nutritional Epidemiology Group

Leeds
LS2 9LN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2010		Yes	No