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 |
| Secondary identifying numbers | FSA N14R0004 |
- 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
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 |
|---|---|
| j.e.cade@leeds.ac.uk |
Study information
| Study design | Cluster randomised controlled trial (randomised by schools) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| 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 | 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 study start date | 01/06/2006 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 9 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Nutritional Epidemiology Group
Leeds
LS2 9LN
United Kingdom
LS2 9LN
United Kingdom
Sponsor information
Food Standards Agency (UK)
Government
Government
Aviation house
125 Kingsway
London
WC2B 6NH
United Kingdom
| Phone | +44 (0)20 7276 8936 |
|---|---|
| Tamara.beckett@foodstandards.gsi.gov.uk | |
| Website | http://www.food.gov.uk/ |
"ROR" |
https://ror.org/05p20a626 |
Funders
Funder type
Government
Food Standards Agency (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
