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

Primary Purpose

Obesity, Childhood, Diet Modification

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Behaviourally Informed Intervention Materials
Sponsored by
Public Health England
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amanda Bunten

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

No intervention materials will be distributed in the control schools during the intervention period.

Intervention materials will be distributed to parents of children in years 3 - 6.

Outcomes

Primary Outcome Measures

Proportion of lunchboxes that contain a sugary snack post-intervention
The proportion of lunchboxes that contain a sugary snack post-intervention
Proportion of lunchboxes that contain a chilled sugary dessert post-intervention
The proportion of lunchboxes that contain a chilled sugary dessert post-intervention

Secondary Outcome Measures

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).
Total number of sugary food items
The total number of sugary food items (i.e. either a sugary snack or chilled sugary dessert)
Proportion of lunch boxes that contain crisps
The proportion of lunch boxes that contain crisps
Proportion of lunch boxes that contain a sugary drink
The proportion of lunch boxes that contain a sugary drink
Proportion of lunch boxes that contain fruit or vegetables
The proportion of lunch boxes that contain fruit or vegetables
The average nutritional value of sugary food items
The average nutritional value (e.g. grams of sugar, calories) of sugary food items

Full Information

First Posted
January 26, 2017
Last Updated
March 2, 2020
Sponsor
Public Health England
Collaborators
Derby City Council, University of Derby
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1. Study Identification

Unique Protocol Identification Number
NCT03104777
Brief Title
A Trial to Improve the Healthiness of Packed Lunches in Primary School Aged Children
Official Title
A Cluster Randomised Controlled Trial Using Behavioural Insights to Improve the Healthiness of Packed Lunches in Primary Schools in Derby
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 9, 2016 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Public Health England
Collaborators
Derby City Council, University of Derby

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Diet Modification

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cluster randomised controlled trial
Masking
Participant
Masking Description
Parents and pupils will not be informed that their school is taking part in this research or that anonymous photographs will be taken of the contents of the lunch boxes brought into school by children in years 3 - 6. Written consent was obtained from the Head Teacher in all participating schools. Providing parents with information about the study is likely to change their behaviour and it will not be possible to assess whether the intervention itself has had an effect.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention materials will be distributed in the control schools during the intervention period.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention materials will be distributed to parents of children in years 3 - 6.
Intervention Type
Behavioral
Intervention Name(s)
Behaviourally Informed Intervention Materials
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of lunchboxes that contain a sugary snack post-intervention
Description
The proportion of lunchboxes that contain a sugary snack post-intervention
Time Frame
Data collected up to 6 months post intervention
Title
Proportion of lunchboxes that contain a chilled sugary dessert post-intervention
Description
The proportion of lunchboxes that contain a chilled sugary dessert post-intervention
Time Frame
Data collected up to 6 months post intervention
Secondary Outcome Measure Information:
Title
Proportion of lunch boxes that contain any sugary food
Description
The proportion of lunch boxes that contain any sugary food (i.e. either a sugary snack or chilled sugary dessert).
Time Frame
Data collected up to 6 months post intervention
Title
Total number of sugary food items
Description
The total number of sugary food items (i.e. either a sugary snack or chilled sugary dessert)
Time Frame
Data collected up to 6 months post intervention
Title
Proportion of lunch boxes that contain crisps
Description
The proportion of lunch boxes that contain crisps
Time Frame
Data collected up to 6 months post intervention
Title
Proportion of lunch boxes that contain a sugary drink
Description
The proportion of lunch boxes that contain a sugary drink
Time Frame
Data collected up to 6 months post intervention
Title
Proportion of lunch boxes that contain fruit or vegetables
Description
The proportion of lunch boxes that contain fruit or vegetables
Time Frame
Data collected up to 6 months post intervention
Title
The average nutritional value of sugary food items
Description
The average nutritional value (e.g. grams of sugar, calories) of sugary food items
Time Frame
Data collected up to 6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Chadborn, PhD
Organizational Affiliation
Public Health England
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amanda K Bunten, Doctorate
Organizational Affiliation
Public Health England
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amanda Bunten
City
London
ZIP/Postal Code
SE1 6LH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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