Evaluation of the PhunkyFoods programme

ISRCTN	ISRCTN15641330
DOI	https://doi.org/10.1186/ISRCTN15641330
Protocol serial number	N/A
Sponsor	Leeds Beckett University
Funder	Nestlé UK Healthy Kids Programme (UK)

Submission date: 30/04/2015
Registration date: 08/05/2015
Last edited: 02/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Schools are encouraged to promote physical activity, boost participation in sports and teach children about healthy foods, however there are no set guidelines on how to go about this. The PhunkyFoods programme is a primary school programme which aims to teach children about healthy lifestyles using fun activities and lessons as part of the standard curriculum. Teaching staff are given the necessary tools and information to teach the aims of the PhunkyFoods programme to pupils. The aim of this study is to see whether the PhunkyFoods programme works to help primary school children take up more physical activity and improve their knowledge of healthy food choices. The results of this study will be used to assess whether the PhunkyFoods programme could be tested in a much larger study involving many more schools.

Who can participate?
Children in Year 2 (age 6-7) and Year 4 (age 8-9) attending schools participating in the study..

What does the study involve?
Children attending participating schools take part in new activities as part of the PhunkyFoods programme during normal school hours alongside the standard curriculum for 18 months. Participating children, parents and school staff are asked to complete questionnaires and attend interviews. Children’s height and weight is recorded.

What are the possible benefits and risks of participating?
The Intervention activity proposed for pupils using the pupil designed to be normal classroom activity fitting within a standard lesson on healthy eating - it does not broach any sensitive issues and is in keeping with healthy eating activities suggested by Teachernet and Wired for Health.
It also provides benefits to teaching staff and schools via staff training and resources to enhance teaching around healthy lifestyles . Completing the height and weight measurements, and the psychological well-being questionnaire can be distressing for some children. However, these measures are undertaken in a private space, confidentiality, anonymity and security assured for all data collected. On the day all children are reminded they have the right to withdraw from the study if they do not wish to complete the measurements collected in this study.

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

When is the study starting and how long is it expected to run for?
June 2012 to April 2015

Who is funding the study?
Nestlé UK Healthy Kids Programme (UK)

Who is the main contact?
Prof P Sahota

Contact information

Prof Pinki Sahota
Public

Social Sciences Leeds Beckett University
CL505
City Campus
Leeds
LS1 3HE
United Kingdom

Study information

Primary study design	Interventional
Study design	Cluster randomised trial
Secondary study design	Cluster randomised trial
Participant information sheet	ISRCTN15641330_PIS_21Sep17_ChildrenParents.pdf
Scientific title	The feasibility and acceptability of PhunkyFoods, a primary school-based programme targeting diet and physical activity: a cluster randomised feasibility trial
Study objectives	The study aims to assess: 1. The feasibility of the PhunkyFood programme (PFP), a nutrition and physical activity education intervention aimed at improving health related knowledge and behaviours related to a healthy lifestyle (diet and physical activity) 2. The acceptability and delivery of the intervention 3. The appropriateness of outcomes and outcome measures 4. The recruitment, retention, and sample size estimation to inform a future randomised control trial (RCT) aimed to evaluate effectiveness.
Ethics approval(s)	Leeds Beckett University (formerly Leeds Metropolitan University) Faculty Ethics Committee, 24/07/2012, ref: 283.
Health condition(s) or problem(s) studied	Implementation of a healthy lifestyle (nutrition and physical activity) intervention in primary schools.
Intervention	The PhunkyFoods Programme (PFP): an early years and primary school programme of healthy lifestyle (nutrition and physical activity) activities, lesson plans and resources. The programme focuses on supporting schools to deliver a whole-school approach to healthy lifestyles and to engage with all children, and their families, in promoting tangible health behaviour changes in a fun, lively and positive manner.
Intervention type	Behavioural
Primary outcome measure(s)	1. How successfully the intervention is implemented and whether there is an indication of effectiveness from a small sample of intervention schools in comparison to the control schools. 2. Process and feasibility measures: recruitment/follow up rates, acceptability, sustainability (based on the project's findings), delivery and compliance with the programme. This information will be used to investigate the feasibility of the intervention and how successfully it is implemented. A nutrition knowledge questionnaire will be used primarily to measure effectiveness. 3. Healthy Lifestyle Knowledge Questionnaire (HLKQ): a healthy lifestyle knowledge questionnaire developed specifically for young children (Years 2-3). The HLKQ is designed to evaluate children’s overall healthy nutrition and physical activity knowledge, which can be broken down into the following domains: nutrition, healthy/balanced diet, ability to identify healthier foods, the Eatwell plate and physical activity knowledge. These domains are based on the learning outcomes of the intervention. These domains create an overall healthy lifestyle score to measure the ability of the programme to influence health-related knowledge score of participating pupils. For the Year 4-5 children, the HLKQ also contains additional sections exploring children’s attitudes towards fruit and vegetables and physical activity. The HLKQ will be conducted at baseline, 6 months and 18 months, with the 18 month follow up as the primary focus for effectiveness.
Key secondary outcome measure(s)	1. Healthy eating behaviours of participating pupils (increased fruit & veg intakes, increased water intake, increased breakfast consumption, decreased high fat/sugary foods/drinks) will be measured by Synchronised Nutrition and Activity Program (SNAP) 2. Change in habitual physical activity levels measured by SNAP 3. Three different measurements will be used to assess intervention effect on psychological well-being (dieting behaviours; body image; self- perceptions (self-esteem, self-worth). These measurements will be taken at baseline, 6 months & 18 months 4. Children’s height/weight will be taken using the procedure recommended by the National Child Measurement Programme Regulations. 5. Interviews: to be conducted with the head teacher, teachers, catering staff and intervention coordinators. The aim of these interviews is to evaluate the effectiveness of the intervention programme on the whole school environment and the curriculum; the acceptability of the intervention, quality of the resources and programme fidelity within the schools, and to identify the impact on the catering staff, parents and wider community. These interviews will be conducted at 6 months and 18 months; intervention coordinator interviews will only be conducted at 18 months. All focus groups will be recorded and critical listening procedures will be applied in the thematic analysis of the data. 6. Focus groups: eight focus groups will be conducted in each school to determine the effect of the intervention on children’s knowledge and attitudes towards healthy eating and physical exercise. In each Year 2 and Year 4 class, 4 single-gender focus groups consisting of 4 pupils will be conducted. A standardised interview schedule will be used to assess differences in knowledge of healthy eating and physical activity between the Intervention and Comparison school pupils. Interviews and focus groups will be conducted by the research fellow and research assistant. All focus groups will be recorded and critical listening procedures will be applied in the thematic analysis of the data. A scoring system will be used to measure change in children’s nutrition and physical activity knowledge over time.
Completion date	01/06/2014

Eligibility

Participant type(s)	Other
Age group	Child
Lower age limit	6 Years
Upper age limit	9 Years
Sex	All
Target sample size at registration	358
Total final enrolment	358
Key inclusion criteria	Eight primary schools (4 intervention and 4 control) will be recruited to take part in the study. Children in Year 2 (age 6-7) and Year 4 (age 8-9) will be involved in the study along with parents, teaching and classroom staff.
Key exclusion criteria	Independent schools, special schools and schools without all 3 Year groups in key stage 2 at primary school (Years 3–6) will be excluded.
Date of first enrolment	01/06/2013
Date of final enrolment	29/09/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Leeds Beckett University

Faculty of Health and Social Sciences
CL505
City Campus
Leeds
LS1 3HE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/11/2015		Yes	No
Other publications	feasibility analysis	20/12/2019	02/01/2020	Yes	No
Participant information sheet		21/09/2017	21/09/2017	No	Yes
Participant information sheet		21/09/2017	21/09/2017	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN15641330_PIS_21Sep17_ChildrenParents.pdf: Uploaded 21/09/2017
ISRCTN15641330_PIS_21Sep17.pdf: Uploaded 21/09/2017

Editorial Notes

02/01/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
21/09/2017: Publication reference added. Added risks and benefits to the Plain English summary. The overall trial dates have been updated from 01/06/2012-01/04/2015 to 01/02/2012-01/06/2014. Recruitment dates have been updated from 01/07/2012 to 01/1/2012 to 01/06/2013-29/09/2013. Patient information sheets have been uploaded. Participant level data sharing statement has been added.
09/08/2017: No publications found in PubMed, verifying study status with principal investigator.