Condition category
Not Applicable
Date applied
30/04/2015
Date assigned
08/05/2015
Last edited
07/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
Not provided at time of registration.

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

Trial website

Contact information

Type

Public

Primary contact

Prof Pinki Sahota

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The feasibility and acceptability of PhunkyFoods, a primary school-based programme targeting diet and physical activity: a cluster randomised feasibility trial

Acronym

Study hypothesis

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

Leeds Beckett University (formerly Leeds Metropolitan University) Faculty Ethics Committee, 24/07/2012, ref: 283.

Study design

Cluster randomised trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/06/2012

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant 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.

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

Eight primary schools, 300+ pupils

Participant 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.

Recruitment start date

01/07/2012

Recruitment end date

01/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Leeds Beckett University

Sponsor details

Faculty of Health and Social Sciences
CL505
City Campus
Leeds
LS1 3HE
United Kingdom
+44 (0)113 812 5500
p.sahota@leedsbeckett.ac.uk

Sponsor type

University/education

Website

www.leedsbeckett.ac.uk

Funders

Funder type

Industry

Funder name

Nestlé UK Healthy Kids Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Main findings will be reported in an academic journal
Conferences – the following conferences will present key results
1 .ECO - May 2015
2. ISBNPA – June 2015

Intention to publish date

01/05/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes