title: Randomised controlled trial and economic evaluation of the 'Families for Health' programme to reduce obesity in children.
abstract: OBJECTIVE
  Evaluating effectiveness and cost-effectiveness of 'Families for Health V2' (FFH) compared with usual care (UC).
  
  
  METHODS
  Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families.
  
  
  METHODS
  Three National Health Service Primary Care Trusts in West Midlands, England.
  
  
  METHODS
  Overweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6-11 years and their parents/carers, recruited March 2012-February 2014.
  
  
  METHODS
  FFH; a 10-week community-based family programme addressing parenting, lifestyle change and social and emotional development. UC; usual support for childhood obesity at each site.
  
  
  METHODS
  Primary outcomes were 12-months change in children's BMI z-score and incremental cost per quality-adjusted life-year gained (QALY). Secondary outcomes included changes in children's physical activity, fruit and vegetable consumption and quality of life, parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style.
  
  
  RESULTS
  115 families (128 children) were randomised to FFH (n=56) or UC (n=59). There was no significant difference in BMI z-score 12-months change (0.114, 95% CI -0.001 to 0.229, p=0.053; p=0.026 in favour of UC with missing value multiple imputation). One secondary outcome, change in children's waist z-score, was significantly different between groups in favour of UC (0.15, 95% CI 0.00 to 0.29). Economic evaluation showed that mean costs were significantly higher for FFH than UC (£998 vs £548, p<0.001). Mean incremental cost-effectiveness of FFH was estimated at £552 175 per QALY.
  
  
  CONCLUSIONS
  FFH was neither effective nor cost-effective for the management of obesity compared with UC.
  
  
  BACKGROUND
  ISRCTN45032201.
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Wendy
authors.initials: W
authors.lastname: Robertson
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Joanna
authors.initials: J
authors.lastname: Fleming
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Atiya
authors.initials: A
authors.lastname: Kamal
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hamborg
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Kamran A
authors.initials: KA
authors.lastname: Khan
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Frances
authors.initials: F
authors.lastname: Griffiths
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Stewart-Brown
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Nigel
authors.initials: N
authors.lastname: Stallard
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Stavros
authors.initials: S
authors.lastname: Petrou
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Douglas
authors.initials: D
authors.lastname: Simkiss
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Harrison
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Sung Wook
authors.initials: SW
authors.lastname: Kim
authors.affiliation: Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
authors.forename: Margaret
authors.initials: M
authors.lastname: Thorogood
mesh_terms: D000886:Anthropometry / Q000379:methods; D015992:Body Mass Index; D002648:Child; D002662:Child Health Services / Q000191:economics / Q000458:organization & administration*; D003362:Cost-Benefit Analysis; D004032:Diet / Q000706:statistics & numerical data; D004739:England; D005192:Family Health; D005247:Feeding Behavior; D005260:Female; D006293:Health Promotion / Q000191:economics / Q000458:organization & administration; D006801:Humans; D008019:Life Style; D008297:Male; D009765:Obesity / Q000191:economics / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000379:methods; D010287:Parent-Child Relations; D016487:Parenting; D011788:Quality of Life; D016037:Single-Blind Method; D012923:Social Class
keywords: Evidence Based Medicine; Nutrition; Obesity; Parenting