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

NCT03104777 | Completed

• 1 other identifier: Derby Packed Lunch Trial
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood; Diet Modification

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Proportion of lunch boxes that contain any sugary food

  Data collected up to 6 months post intervention

• Total number of sugary food items

  Data collected up to 6 months post intervention

• Proportion of lunch boxes that contain crisps

  Data collected up to 6 months post intervention

• Proportion of lunch boxes that contain a sugary drink

  Data collected up to 6 months post intervention

• Proportion of lunch boxes that contain fruit or vegetables

  Data collected up to 6 months post intervention

Study Arms (2)

Control Group

NO INTERVENTION

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

Intervention Group

EXPERIMENTAL

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

Behavioral: Behaviourally Informed Intervention Materials

Interventions

Behaviourally Informed Intervention Materials BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All primary schools in Derby City
• Children in Years 3-6

You may not qualify if:

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

Sponsors & Collaborators

• Public Health England: lead
• Derby City Council: collaborator
• University of Derby: collaborator

Study Sites (1)

Amanda Bunten

London, SE1 6LH, United Kingdom

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tim Chadborn, PhD

  Public Health England

  STUDY DIRECTOR

• Amanda K Bunten, Doctorate

  Public Health England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: cluster randomised controlled trial

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: April 7, 2017
• Study Start: November 9, 2016
• Primary Completion: September 30, 2017
• Study Completion: October 30, 2017
• Last Updated: March 3, 2020

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)