title: The Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Over the last three decades there has been a substantial increase in the proportion of children who are overweight or obese. The Healthy Lifestyles Programme (HeLP) is a novel school-based intervention, using highly interactive and creative delivery methods to prevent obesity in children.
  
  
  METHODS
  We describe a cluster randomised controlled trial to evaluate the effectiveness and cost effectiveness of HeLP. The intervention has been developed using intervention mapping (involving extensive stakeholder involvement) and has been guided by the Information, Motivation, Behavioural Skills model. HeLP includes creating a receptive environment, drama activities, goal setting and reinforcement activities and runs over three school terms. Piloting showed that 9 to 10 year olds were the most receptive and participative. This study aims to recruit 1,300 children from 32 schools (over half of which will have ≥19% of pupils eligible for free school meals) from the southwest of England. Participating schools will be randomised to intervention or control groups with baseline measures taken prior to randomisation. The primary outcome is change in body mass index standard deviation score (BMI SDS) at 24 months post baseline. Secondary outcomes include, waist circumference and percent body fat SDS and proportion of children classified as overweight or obese at 18 and 24 months and objectively measured physical activity and food intake at 18 months. Between-group comparisons will be made using random effects regression analysis taking into account the hierarchical nature of the study design. An economic evaluation will estimate the incremental cost-effectiveness of HeLP, compared to control, from the perspective of the National Health Service (NHS)/third party payer. An in-depth process evaluation will provide insight into how HeLP works, and whether there is any differential uptake or engagement with the programme.
  
  
  CONCLUSIONS
  The results of the trial will provide evidence on the effectiveness and cost effectiveness of the Healthy Lifestyles Programme in affecting the weight status of children.
  
  
  BACKGROUND
  ISRCTN15811706.
authors.affiliation: Institute of Health Services Research, University of Exeter Medical School (formerly Peninsula College of Medicine and Dentistry), Veysey Building, Salmon Pool Lane, Exeter, Devon EX2 4SG, UK. k.m.wyatt@ex.ac.uk
authors.forename: Katrina M
authors.initials: KM
authors.lastname: Wyatt
authors.forename: Jennifer J
authors.initials: JJ
authors.lastname: Lloyd
authors.forename: Charles
authors.initials: C
authors.lastname: Abraham
authors.forename: Siobhan
authors.initials: S
authors.lastname: Creanor
authors.forename: Sarah
authors.initials: S
authors.lastname: Dean
authors.forename: Emma
authors.initials: E
authors.lastname: Densham
authors.forename: Wendy
authors.initials: W
authors.lastname: Daurge
authors.forename: Colin
authors.initials: C
authors.lastname: Green
authors.forename: Melvyn
authors.initials: M
authors.lastname: Hillsdon
authors.forename: Virginia
authors.initials: V
authors.lastname: Pearson
authors.forename: Rod S
authors.initials: RS
authors.lastname: Taylor
authors.forename: Richard
authors.initials: R
authors.lastname: Tomlinson
authors.forename: Stuart
authors.initials: S
authors.lastname: Logan
mesh_terms: D050154:Adiposity; D015992:Body Mass Index; D002648:Child; D002652:Child Behavior; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004032:Diet / Q000009:adverse effects; D004739:England; D015444:Exercise; D005247:Feeding Behavior; D006040:Goals; D015438:Health Behavior; D017048:Health Care Costs; D006293:Health Promotion / Q000191:economics; D006801:Humans; D009043:Motor Activity; D009765:Obesity / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D012054:Reinforcement, Psychology; D012107:Research Design; D040242:Risk Reduction Behavior; D012572:School Health Services / Q000191:economics; D013222:State Medicine / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D055105:Waist Circumference
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