title: The Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Low levels of physical activity, high levels of sedentary behaviour and low levels of fruit and vegetable consumption are common in children and are associated with adverse health outcomes. The aim of this paper is to describe the protocol for a cluster randomised controlled trial (RCT) designed to evaluate a school-based intervention that aims to increase levels of physical activity, decrease sedentary behaviour and increase consumption of fruit and vegetables in school children.
  
  
  METHODS
  The Active for Life Year 5 (AFLY5) study is a school-based, cluster RCT that targets school children in Year 5 (age 9-10 years). All state junior/primary schools in the area covered by Bristol City and North Somerset Council are invited to participate; special schools are excluded. Eligible schools are randomised to one of two arms: intervention arm (receive the intervention 2011-2012) and control arm (receive the intervention after the final follow-up assessment, 2013-2014). The primary outcomes of the trial are levels of accelerometer assessed physical activity and sedentary behaviour and questionnaire assessed fruit and vegetable consumption. A number of secondary outcomes will also be measured, including body mass index, waist circumference and overweight/obesity. Outcomes will be assessed at baseline (prior to intervention when the children are in Year 4), at the end of intervention 'immediate follow-up' and '12 months long-term' follow-up. We will use random effects linear and logistic regression models to compare outcomes by randomised arm. The economic evaluation from a societal perspective will take the form of a cost consequence analysis. Data from focus groups and interviews with pupils, parents and teachers will be used to increase understanding of how the intervention has any effect and is integrated into normal school activity.
  
  
  CONCLUSIONS
  The results of the trial will provide information about the public health effectiveness of a school-based intervention aimed at improving levels of physical activity, sedentary behaviour and diet in children.
  
  
  BACKGROUND
  ISRCTN50133740.
authors.affiliation: MRC Centre for Causal Analyses in Translational Epidemiology, University of Bristol, UK. d.a.lawlor@bristol.ac.uk
authors.forename: Debbie A
authors.initials: DA
authors.lastname: Lawlor
authors.forename: Russell
authors.initials: R
authors.lastname: Jago
authors.forename: Sian M
authors.initials: SM
authors.lastname: Noble
authors.forename: Catherine R
authors.initials: CR
authors.lastname: Chittleborough
authors.forename: Rona
authors.initials: R
authors.lastname: Campbell
authors.forename: Julie
authors.initials: J
authors.lastname: Mytton
authors.forename: Laura D
authors.initials: LD
authors.lastname: Howe
authors.forename: Tim J
authors.initials: TJ
authors.lastname: Peters
authors.forename: Ruth R
authors.initials: RR
authors.lastname: Kipping
mesh_terms: D056044:Actigraphy / Q000295:instrumentation; D015992:Body Mass Index; D002648:Child; D016000:Cluster Analysis; D003362:Cost-Benefit Analysis; D004032:Diet / Q000191:economics; D004739:England; D005260:Female; D005638:Fruit; D017048:Health Care Costs; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D009043:Motor Activity; D009765:Obesity / Q000175:diagnosis / Q000191:economics / Q000517:prevention & control*; D050177:Overweight / Q000175:diagnosis / Q000191:economics / Q000517:prevention & control*; D012107:Research Design; D040242:Risk Reduction Behavior; D012574:Schools / Q000191:economics; D057185:Sedentary Behavior; D011795:Surveys and Questionnaires; D013997:Time Factors; D014675:Vegetables; D055105:Waist Circumference