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ISRCTN
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ISRCTN03863885
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DOI
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10.1186/ISRCTN03863885
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The CHANGE! (Children's Health, Activity and Nutrition: Get Educated!) Project
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Scientific title
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The CHANGE! (Children's Health, Activity and Nutrition: Get Educated!) Project: a clustered randomised controlled trial
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Acronym
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CHANGE!
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Serial number at source
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CHANGE! Protocol V.1.0
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Study hypothesis
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Participants in the CHANGE! intervention group will accrue more moderate to vigorous physical activity post intervention than the control group.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Liverpool John Moores Research Ethics Committee approved on 22nd September 2010, reference number 10/ECL/039
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Study design
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Clustered randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Paediatric health, physical activity, exercise science and nutrition disciplines
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Participants - inclusion criteria
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Within the twelve participating schools:
1. All year 6 children were invited to take part
2. All children with informed parental consent, participant assent and medical screening were eligible to take part
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Participants - exclusion criteria
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Children without parental consent, participant assent or those with a medical condition that precluded them from taking part in the programme
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Anticipated start date
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01/10/2010
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Anticipated end date
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31/07/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Three-hundred 10-11.9yr old children
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Interventions
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The CHANGE! pilot study is a clustered randomised controlled trial (RCT) investigating the efficacy of a twenty lesson school-based physical activity and healthy eating intervention. CHANGE! is delivered through the Personal and Social Health Education strand of school’s curricula and the curriculum resource is supplemented by homework tasks that target family involvement.
Twelve schools from the Wigan Borough in North-West England were recruited to the study, Six randomly assigned using a random number generator to the intervention condition. Randomisation occurred prior to baseline measures. Class teachers from the intervention schools received training in the curriculum resource over two twilight training sessions, and were fully familiarised with the CHANGE! curriculum prior to implementation. CHANGE! consists of 20 lesson plans, including worksheets and other resources. This curriculum resource is supplemented by homework tasks that target family involvement. Control schools will receive the curriculum and training in the following academic year once the study has been completed. Measures were completed for intervention and control groups at baseline and will be repeated post-intervention (20 weeks) and at 30-32 weeks follow up, prior to the school summer holidays.
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Primary outcome measure(s)
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Levels of habitual physical activity, moderate to vigorous physical activity (MVPA)-outcome measured at baseline and will be repeated post-intervention (20 weeks) and at 30-32 weeks follow up, prior to the school summer holidays.
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Secondary outcome measure(s)
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1. Anthropometrics and body composition
2. Cardiorespiratory fitness
3. Food intake
4. Eating behaviour and knowledge
5. Physical self-perceptions
6. Family nutrition and physical activity
7. Behaviour change
8. Quality of life
9. Cardiometabolic disease risk markers
10. Fundamental movement skills
Outcomes were measured at baseline and will be repeated post-intervention (20 weeks) and at 30-32 weeks follow up, prior to the school summer holidays.
To reduce ionising radiation dosage, DEXA body composition scans will be conducted at baseline and follow-up only.
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Sources of funding
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Liverpool John Moores University (UK)
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Trial website
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Publications
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1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22931457
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Contact name
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Dr
Stuart
Fairclough
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Address
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Faculty of Education, Community and Leisure,
Liverpool John Moores University,
IM Marsh Campus,
Barkhill Road,
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City/town
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Liverpool
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Zip/Postcode
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L17 6BD
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Country
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United Kingdom
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Sponsor
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Liverpool John Moores University (UK)
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Address
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Research Support Office,
Liverpool John Moores University,
c/o Dr. Sue Spiers
Kingsway House,
Hatton Garden,
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City/town
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Liverpool
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Zip/Postcode
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L3 2AJ
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Country
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United Kingdom
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Date applied
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16/02/2011
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Last edited
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21/03/2013
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Date ISRCTN assigned
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17/03/2011
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