A Trial to Improve the Healthiness of Packed Lunches in Primary School Aged Children

Obesity, Childhood Clinical Trial

Official title:

A Cluster Randomised Controlled Trial Using Behavioural Insights to Improve the Healthiness of Packed Lunches in Primary Schools in Derby

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104777
• Other study ID #: Derby Packed Lunch Trial
• Status: Completed
• Phase: N/A
• Start date: November 9, 2016
• Est. completion date: October 30, 2017

Study information

• Verified date: January 2017
• Source: Public Health England
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Public Health England's (PHE) Behavioural Insights Team are leading and fully funding a randomised controlled research trial in collaboration with Derby City Council's Public Health Team and the Health and Social Care Research Centre at Derby University to test an intervention designed to help families provide healthier packed lunches for Primary School aged children.

Description:

Children in Derby gain more weight during primary school than the national average. For 4-5 year olds, Derby is in the best performing quartile of English councils, with 20% having excess weight. However, by the age of 10-11 Derby drops to the second lowest quartile, with 35% of children having excess weight . In order to reduce childhood obesity in Derby, primary schools are a key area to focus on. Furthermore, it is a priority to focus on children living in deprived areas, as there is a strong relationship between deprivation and childhood obesity.

Research shows that packed lunches are higher in sugar, salt and saturated fat than school meals. , Furthermore, the nutritional gap between packed lunches and school meals has widened since the introduction of the food-based standards for school meals in 2006. A cross sectional survey, assessing packed lunches of 1,294 children in 87 primary schools, found only 1% met the standards for school meals in England, with 82% containing restricted snacks, i.e., crisps or confectionary, and 61% including sugar sweetened drinks. Therefore, significantly improving the quality of packed lunches could be an important step to reducing childhood obesity rates in Derby.

Previous research has highlighted that improving the quality of packed lunches can be challenging. For example, a UK-wide randomised controlled trial found that a "SMART lunch box" intervention had a positive impact on certain food groups but failed to reduce the overall calories in lunchboxes. The intervention, which included an extensive set of approaches, e.g., lunch bags, food boxes, wall charts, food games and stickers, increased vegetables packed by 11% and decreased savoury snacks packed by 14%, but failed to reduce confectionary and sweetened drinks . Other interventions, using educational videos and incentives aimed at children, had similar small, yet positive effects over a 12-month period . However, research has shown that relatively small, sustained behavioural changes can have a big cumulative impact: reducing calorie consumption by just 30-100 calories a day would have a considerable effect on obesity levels . The small effects of previous studies also highlight the importance of robustly evaluating any approach that is introduced.

In order to reduce childhood obesity in Derby, primary schools are a key area to focus on. Research shows that packed lunches are higher in sugar, salt and saturated fat than school meals, and a survey found only 1% of packed lunches met the standards for school meals in England . Therefore, significantly improving the quality of packed lunches could be an important step to reducing childhood obesity rates in Derby.

This trial is designed to test whether a multiple component intervention, focused on parents and developed with an understanding of the drivers behind behaviour, can increase the healthiness of packed lunches brought into school by reducing the presence of unhealthy items.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

• All primary schools in Derby City

• Children in Years 3-6

Exclusion Criteria:

• Children in Years 1 - 2 due to universal provision of free school meals.

Related Conditions & MeSH terms

• Diet Modification
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Behaviourally Informed Intervention Materials
The intervention consists of 7 separate components. The intervention components are to be delivered at three time-points (referred to as bundles). The bundles consist of: Bundle 1a - Letter to parents of children bringing a packed lunch to school, 'spot the difference' lunch box tag (attached to all lunchboxes) and a Handy Swaps Card. Bundle 1b - Letter to parents of children only having school meals and a Handy Swaps Card. Bundle 2 - Lunch box mixer with ideas for creating nutritious packed lunches. Bundle 3 - Shopping list, packed lunch planner and reward chart to support planning and monitoring progress.

Locations

Country	Name	City	State
United Kingdom	Amanda Bunten	London

Sponsors (3)

Lead Sponsor	Collaborator
Public Health England	Derby City Council, University of Derby

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of lunchboxes that contain a sugary snack post-intervention	The proportion of lunchboxes that contain a sugary snack post-intervention	Data collected up to 6 months post intervention
Primary	Proportion of lunchboxes that contain a chilled sugary dessert post-intervention	The proportion of lunchboxes that contain a chilled sugary dessert post-intervention	Data collected up to 6 months post intervention
Secondary	Proportion of lunch boxes that contain any sugary food	The proportion of lunch boxes that contain any sugary food (i.e. either a sugary snack or chilled sugary dessert).	Data collected up to 6 months post intervention
Secondary	Total number of sugary food items	The total number of sugary food items (i.e. either a sugary snack or chilled sugary dessert)	Data collected up to 6 months post intervention
Secondary	Proportion of lunch boxes that contain crisps	The proportion of lunch boxes that contain crisps	Data collected up to 6 months post intervention
Secondary	Proportion of lunch boxes that contain a sugary drink	The proportion of lunch boxes that contain a sugary drink	Data collected up to 6 months post intervention
Secondary	Proportion of lunch boxes that contain fruit or vegetables	The proportion of lunch boxes that contain fruit or vegetables	Data collected up to 6 months post intervention
Secondary	The average nutritional value of sugary food items	The average nutritional value (e.g. grams of sugar, calories) of sugary food items	Data collected up to 6 months post intervention