ISRCTN ISRCTN68114155
DOI https://doi.org/10.1186/ISRCTN68114155
Secondary identifying numbers KV2021-23PhunkyClusterRCT
Submission date
18/10/2021
Registration date
22/10/2021
Last edited
10/09/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
PhunkyFoods is a healthy living intervention delivered in primary schools in the UK. Participating school staff are supported with training, school food policy and have access to curriculum resources to improve the delivery of food education. Children can participate in whole school assemblies, classroom activities, and after school clubs about food preparation, cooking healthy meals and healthy living. Schools, parents and children have access to healthy meal recipes through the PhunkyFoods website. This study aims to evaluate the impact of the PhunkyFoods programme on food literacy, cooking skills and eating habits of children aged 6-9 years.

Who can participate?
Pupils aged 7 - 9 years in years 3 and 4 at primary schools in Harrogate and Selby

What does the study involve?
The PhunkyFoods intervention is a flexible programme of options for schools to select from, including whole school assemblies, staff training, classroom activities, school food policy development, after school clubs, student ambassadors, child and parent cook clubs and parent information events.
The study aims to find out what the impact of the PhunkyFoods programme is on children's knowledge about food and nutrition, as well as their food preparation skills and dietary habits. To assess the impact, the research team will collect data through surveys at the beginning of the study and then 8 months after the PhunkyFoods intervention. There will be a short child survey about food and nutrition and cooking skills completed in the classroom. There will be a short food diary for parents to complete about their child's fruit and vegetable intake.
To compare, there will be 15 schools that receive the PhunkyFoods intervention and also 15 schools that receive the normal school curriculum. The researchers will look at all the data collected from the surveys to see if the PhunkyFoods intervention increases food literacy, cooking skills and improves dietary habits compared to schools that do not receive the intervention during the same time period. This comparison is to make sure that any changes are really a result of the PhunkyFoods intervention programme.

What are the possible benefits and risks of participating?
The PhunkyFoods programme could help to increase children's knowledge about food, nutrition and their cooking and food preparation skills. Families could be supported to have a healthy varied diet and higher consumption of fruit and vegetables. The risks are not higher than for any normal school activities. Foods to which a participating child is allergic will not be used. Children involved in food preparation and cooking activities will be supervised by a responsible adult.

Where is the study run from?
University of Leeds (UK)

When is the study starting and how long is it expected to run for?
August 2021 to April 2023

Who is funding the study?
The Phunkyfoods intervention programme is funded through the Nestle Healthy Kids programme and Purely Nutrition. The study is investigator funded with some financial support from the WHO Collaborating Centre for Nutritional Epidemiology in Leeds (UK)

Who is the main contact?
Karen Vaughan
mc17kv@leeds.ac.uk

Contact information

Mrs Karen Vaughan
Public

School of Food Science and Nutrition
G11 Stead House
University of Leeds
Leeds
LS2 9JT
United Kingdom

ORCiD logoORCID ID 0000-0003-0387-4531
Phone +44 (0)113 343 2876
Email mc17kv@leeds.ac.uk
Dr Charlotte Evans
Scientific

School of Food Science and Nutrition
G11 Stead House
University of Leeds
Leeds
LS2 9JT
United Kingdom

ORCiD logoORCID ID 0000-0002-4065-4397
Phone +44 (0)113 343 3956
Email c.e.l.evans@leeds.ac.uk

Study information

Study designCluster randomized control trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typePrevention
Participant information sheet ISRCTN68114155_PIS_V2.pdf
Scientific titleEvaluation of the PhunkyFoods intervention on food literacy and cooking skills of children aged 7 – 9 years: a cluster randomised controlled trial in Yorkshire Primary Schools UK
Study acronymPhunkyFoods Cluster-RCT
Study hypothesisThe hypothesis of the study is that the PhunkyFoods intervention group will show higher mean scores for food literacy and cooking skills than the mean scores of the control group.
Ethics approval(s)Approved 30/09/2021, School of Business, Environment and Social Services (AREA) Committee at the University of Leeds (The Secretariat, University of Leeds, LS2 9NL, UK; +44 (0)113 343 2876; researchethics@leeds.ac.uk), ref: AREA 21-011
ConditionHealthy dietary choices and prevention of obesity
InterventionParticipants will be children aged 7 - 9 years in UK primary schools. Schools based in North Yorkshire (in Harrogate or Selby) will be eligible to volunteer or self-select to participate.

Cluster randomization is at the school level. Randomization at the cluster level will be undertaken after baseline measures are collected so that stratified sampling can be used to minimize the imbalance between covariate means. Randomization will be to either the PhunkyFoods intervention group or to the Control (no intervention) group at a ratio of 1:1. There will be no masking for school and child participants, as the intervention is an experiential teaching programme and therefore cannot be masked.

The PhunkyFoods intervention is a flexible programme of options for schools to select from, including whole school assemblies, staff training, classroom activities, school food policy development, after school clubs, student ambassadors, child and parent cook clubs and parent information events.
Intervention typeBehavioural
Primary outcome measure1. Food literacy measured by the Tool for Food Literacy Assessment in Children (TFLAC - UK) at baseline (T1) and at 8 months post-intervention delivery (T2)
2. Cooking skills measured by the CooC11 child survey at baseline (T1) and at 8 months post-intervention delivery (T2)
Secondary outcome measuresFruit and vegetable intake measured using the Child Assessment of Diet Evaluation Tool (CADET) at baseline (T1) and at 8 months post-intervention delivery (T2)
Overall study start date01/08/2021
Overall study end date30/04/2023

Eligibility

Participant type(s)Other
Age groupChild
Lower age limit7 Years
Upper age limit9 Years
SexBoth
Target number of participantsThe target number of participants is 400+. The study design is for 30 clusters (schools), with 15 in each arm of the trial. Each cluster will have a minimum of 15 children for an effectively powered study. To make this practical in schools, and to allow for drop out and loss to follow-up, each school will have one class of 20-30 children participating, depending on how many are in the class that the school selects. Only classes in year groups 3 and 4 will be included. Schools serving communities with high levels of deprivation are especially welcome.
Total final enrolment704
Participant inclusion criteriaChildren aged 7 – 9 years in mainstream primary schools
Participant exclusion criteriaChildren in years reception, 1, 2, 5 or 6
Recruitment start date15/12/2021
Recruitment end date24/03/2022

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Leeds
School of Food Science and Nutrition
G11 Stead House
Leeds
LS2 9JT
United Kingdom

Sponsor information

University of Leeds
University/education

c/o Prof. Jason Halford
G.02 Psychology Building
University of Leeds
Leeds
LS2 9JT
England
United Kingdom

Phone +44 (0)113 343 6678
Email J.Halford@leeds.ac.uk
Website https://www.leeds.ac.uk
ROR logo "ROR" https://ror.org/024mrxd33

Funders

Funder type

Other

Investigator initiated and funded

No information available

Nestle Healthy Kids

No information available

Purely Nutrition

No information available

Results and Publications

Intention to publish date31/10/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in non-publicly available repository
Publication and dissemination plan1. Protocol paper, to submit by end of 2021, early 2022
2. Interim results may be reported in a conference submission in Summer 2023, ahead of a publication in a journal
3. One or two journal papers detailing the findings of methods, RCT outcomes to submit around December 2023
4. A study protocol and statistical analysis plan will be provided when this is available
IPD sharing planElectronic data will be stored on the University of Leeds SAN (Storage Area Network), which comprises enterprise-level disk storage and file servers located in physically secure data centres with appropriate fire suppression equipment. Snapshots are taken every day at 10 pm (and accessible for 1 month). A second level of snapshots is taken every month and are kept for 11 months. Snapshots are user recoverable from the desktop. Consent to store data will be obtained and the data will be anonymised.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version 2 16/12/2021 No Yes
Protocol article 01/08/2022 01/08/2022 Yes No

Additional files

ISRCTN68114155_PIS_V2.pdf

Editorial Notes

10/09/2024: The intention to publish date was changed from 31/03/2024 to 31/10/2024.
18/07/2023: The following changes have been made and the plain English summary updated accordingly:
1. The overall study end date was changed from 31/07/2023 to 30/04/2023.
2. The total final enrolment was added.
3. The intention to publish date was changed from 01/12/2023 to 31/03/2024.
4. The recruitment start date has been changed from 01/12/2021 to 15/12/2021.
5. The recruitment end date has been changed from 30/03/2022 to 24/03/2022.
01/08/2022: Publication reference added.
16/12/2021: The participant information sheet has been uploaded.
21/10/2021: Trial's existence confirmed by the AREA ethics committee at University of Leeds.