title: Outcomes and costs of primary care surveillance and intervention for overweight or obese children: the LEAP 2 randomised controlled trial.
abstract: OBJECTIVE
  To determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children.
  
  
  METHODS
  Randomised controlled trial nested within a baseline cross sectional survey of body mass index (BMI). Randomisation and outcomes measurement, but not participants, were blinded to group assignment.
  
  
  METHODS
  45 family practices (66 general practitioners) in Melbourne, Australia.
  
  
  METHODS
  3958 children visiting their general practitioner in May 2005-July 2006 were surveyed for BMI. Of these, 258 children aged 5 years 0 months up to their 10th birthday who were overweight or obese by International Obesity Taskforce criteria were randomised to intervention (n=139) or control (n=119) groups. Children who were very obese (UK BMI z score >or=3.0) were excluded.
  
  
  METHODS
  Four standard consultations over 12 weeks targeting change in nutrition, physical activity, and sedentary behaviour, supported by purpose designed family materials. Main outcomes measures Primary measure was BMI at 6 and 12 months after randomisation. Secondary measures were mean activity count/min by 7-day accelerometry, nutrition score from 4-day abbreviated food frequency diary, and child health related quality of life. Differences were adjusted for socioeconomic status, age, sex, and baseline BMI.
  
  
  RESULTS
  Of 781 eligible children, 258 (33%) entered the trial; attrition was 3.1% at 6 months and 6.2% at 12 months. Adjusted mean differences (intervention - control) at 6 and 12 months were, for BMI, -0.12 (95% CI -0.40 to 0.15, P=0.4) and -0.11 (-0.45 to 0.22, P=0.5); for physical activity in counts/min, 24 (-4 to 52, P=0.09) and 11 (-26 to 49, P=0.6); and, for nutrition score, 0.2 (-0.03 to 0.4, P=0.1) and 0.1 (-0.1 to 0.4, P=0.2). There was no evidence of harm to the child. Costs to the healthcare system were significantly higher in the intervention arm.
  
  
  CONCLUSIONS
  Primary care screening followed by brief counselling did not improve BMI, physical activity, or nutrition in overweight or mildly obese 5-10 year olds, and it would be very costly if universally implemented. These findings are at odds with national policies in countries including the US, UK, and Australia.
  
  
  BACKGROUND
  ISRCTN 52511065 (www.isrctn.org).
authors.affiliation: Royal Children's Hospital, Murdoch Childrens Research Institute and University of Melbourne, Parkville, Vic 3052, Australia. melissa.wake@rch.org.au
authors.forename: Melissa
authors.initials: M
authors.lastname: Wake
authors.forename: Louise A
authors.initials: LA
authors.lastname: Baur
authors.forename: Bibi
authors.initials: B
authors.lastname: Gerner
authors.forename: Kay
authors.initials: K
authors.lastname: Gibbons
authors.forename: Lisa
authors.initials: L
authors.lastname: Gold
authors.forename: Jane
authors.initials: J
authors.lastname: Gunn
authors.forename: Penny
authors.initials: P
authors.lastname: Levickis
authors.forename: Zoë
authors.initials: Z
authors.lastname: McCallum
authors.forename: Geraldine
authors.initials: G
authors.lastname: Naughton
authors.forename: Lena
authors.initials: L
authors.lastname: Sanci
authors.forename: Obioha C
authors.initials: OC
authors.lastname: Ukoumunne
mesh_terms: D015992:Body Mass Index; D002648:Child; D002675:Child, Preschool; D015444:Exercise / Q000502:physiology; D005194:Family Practice / Q000191:economics*; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D015201:Meta-Analysis as Topic; D009765:Obesity / Q000191:economics / Q000517:prevention & control; D050177:Overweight / Q000191:economics* / Q000517:prevention & control; D012959:Socioeconomic Factors; D016896:Treatment Outcome