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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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21 January 2020 |
Main ID: |
ISRCTN15641330 |
Date of registration:
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08/05/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluation of the PhunkyFoods programme
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Scientific title:
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The feasibility and acceptability of PhunkyFoods, a primary school-based programme targeting diet and physical activity: a cluster randomised feasibility trial |
Date of first enrolment:
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01/06/2013 |
Target sample size:
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358 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN15641330 |
Study type:
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Interventional |
Study design:
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Cluster randomised trial (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Pinki
Sahota |
Address:
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Social Sciences Leeds Beckett University
CL505
City Campus
LS1 3HE
Leeds
United Kingdom |
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Key inclusion & exclusion criteria
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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.
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.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Implementation of a healthy lifestyle (nutrition and physical activity) intervention in primary schools. Not Applicable
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Nestlé UK Healthy Kids Programme (UK)
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Ethics review
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Status:
Approval date:
Contact:
Leeds Beckett University (formerly Leeds Metropolitan University) Faculty Ethics Committee, 24/07/2012, ref: 283.
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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01/06/2014 |
URL:
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