title: Trial baseline characteristics of a cluster randomised controlled trial of a school-located obesity prevention programme; the Healthy Lifestyles Programme (HeLP) trial.
abstract: We have developed a healthy lifestyles programme (HeLP) for primary school aged children (9-10 years), currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity) by gender, cluster level socio-economic status, school size and time of recruitment into the trial.
  
  
  
  Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP) or control (usual practice) stratified by the proportion of children eligible for free school meals (FSM, <19%, ≥19%) and school size (one Year 5 class, >1 Year 5 class). The primary outcome is change in body mass index standard deviation score (BMI sds) at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample) and food intake at 18 months.
  
  
  
  At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8%) and children from schools in FSM category 2 (28.2% vs 23.2%) were overweight or obese. Children were consuming a mean (range) of 4.15 (0-13) energy dense snacks (EDS) and 3.23 (0-9) healthy snacks (HS) per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8) in MVPA and thirteen hours (779.3 min) per day (11 h to 15 h) doing less than 'light' intensity activity. Less than 5% of children achieved the Departments of Health's recommendation of 60 min of MVPA every day.
  
  
  
  We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not seen before in other large scale studies. Our anthropometric baseline data is representative of local and national data for children this age and reflects the gender and socio-economic variations expected of children this age in relation to physical activity and weight status.
  
  
  
  ISRCTN15811706 (1/05/2012).
authors.affiliation: University of Exeter Medical School, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK. J.J.Lloyd@exeter.ac.uk.
authors.forename: Jenny
authors.identifier: 0000-0003-3211-5972
authors.initials: J
authors.lastname: Lloyd
authors.affiliation: Peninsula Clinical Trials Unit and Biostatistics, Bioinformatics & Biomarkers Group, Plymouth University Peninsula Schools of Medicine & Dentistry (formerly Peninsula College of Medicine and Dentistry), ITTC Building, Plymouth Science Park, Plymouth, Devon, PL6 8BX, UK.
authors.forename: Siobhan
authors.initials: S
authors.lastname: Creanor
authors.affiliation: Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
authors.forename: Lisa
authors.initials: L
authors.lastname: Price
authors.affiliation: University of Exeter Medical School, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: Abraham
authors.affiliation: University of Exeter Medical School, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Dean
authors.affiliation: University of Exeter Medical School, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Green
authors.affiliation: Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
authors.forename: Melvyn
authors.initials: M
authors.lastname: Hillsdon
authors.affiliation: Public Health Devon, Devon County Council, County Hall, Topsham Road, Exeter, EX2 4QL, UK.
authors.forename: Virginia
authors.initials: V
authors.lastname: Pearson
authors.affiliation: University of Exeter Medical School, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
authors.forename: Rod S
authors.initials: RS
authors.lastname: Taylor
authors.affiliation: Department of Child Health Barrack Road, Royal Devon and Exeter Hospital, Royal Devon & Exeter NHS Trust, Exeter, EX2 5DW, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Tomlinson
authors.affiliation: University of Exeter Medical School, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
authors.forename: Stuart
authors.initials: S
authors.lastname: Logan
authors.affiliation: University of Exeter Medical School, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Hurst
authors.affiliation: Isca Academy, Devon, EX2 6AP, UK.
authors.forename: Emma
authors.initials: E
authors.lastname: Ryan
authors.affiliation: St Leonard's Primary School, Exeter, Devon, EX2 4NQ, UK.
authors.forename: Wendy
authors.initials: W
authors.lastname: Daurge
authors.affiliation: University of Exeter Medical School, University of Exeter St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
authors.forename: Katrina
authors.initials: K
authors.lastname: Wyatt
mesh_terms: D015992:Body Mass Index; D001835:Body Weight; D002648:Child; D004032:Diet; D004739:England; D015444:Exercise; D005247:Feeding Behavior; D005260:Female; D006293:Health Promotion / Q000458:organization & administration*; D000070497:Healthy Lifestyle; D006801:Humans; D008297:Male; D050177:Overweight / Q000517:prevention & control; D063766:Pediatric Obesity / Q000517:prevention & control*; D012107:Research Design; D012572:School Health Services / Q000458:organization & administration*; D055105:Waist Circumference
keywords: Child; Cluster randomised controlled trial; Complex intervention; Obesity prevention; School