title: Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Effective programs to help children manage their weight are required. Families for Health focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health V1 showed sustained reductions in overweight after 2 years in a pilot evaluation, but lacks a randomized controlled trial (RCT) evidence base.
  
  
  METHODS
  This is a multi-center, investigator-blind RCT, with parallel economic evaluation, with a 12-month follow-up. The trial will recruit 120 families with at least one child aged 6 to 11 years who is overweight (≥91st centile BMI) or obese (≥98th centile BMI) from three localities and assigned randomly to Families for Health V2 (60 families) or the usual care control (60 families) groups. Randomization will be stratified by locality (Coventry, Warwickshire, Wolverhampton).Families for Health V2 is a family-based intervention run in a community venue. Parents/carers and children attend parallel groups for 2.5 hours weekly for 10 weeks. The usual care arm will be the usual support provided within each NHS locality.A mixed-methods evaluation will be carried out. Child and parent participants will be assessed at home visits at baseline, 3-month (post-treatment) and 12-month follow-up. The primary outcome measure is the change in the children's BMI z-scores at 12 months from the baseline. Secondary outcome measures include changes in the children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. The parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style will also be assessed.Economic components will encompass the measurement and valuation of service utilization, including the costs of running Families for Health and usual care, and the EuroQol EQ-5D health outcomes. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program.Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made.
  
  
  CONCLUSIONS
  This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation.
  
  
  BACKGROUND
  Current Controlled Trials http://ISRCTN45032201.
authors.affiliation: Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK. w.robertson@warwick.ac.uk
authors.forename: Wendy
authors.initials: W
authors.lastname: Robertson
authors.forename: Sarah
authors.initials: S
authors.lastname: Stewart-Brown
authors.forename: Nigel
authors.initials: N
authors.lastname: Stallard
authors.forename: Stavros
authors.initials: S
authors.lastname: Petrou
authors.forename: Frances
authors.initials: F
authors.lastname: Griffiths
authors.forename: Margaret
authors.initials: M
authors.lastname: Thorogood
authors.forename: Douglas
authors.initials: D
authors.lastname: Simkiss
authors.forename: Rebecca
authors.initials: R
authors.lastname: Lang
authors.forename: Kate
authors.initials: K
authors.lastname: Reddington
authors.forename: Fran
authors.initials: F
authors.lastname: Poole
authors.forename: Gloria
authors.initials: G
authors.lastname: Rye
authors.forename: Kamran A
authors.initials: KA
authors.lastname: Khan
authors.forename: Thomas
authors.initials: T
authors.lastname: Hamborg
authors.forename: Joanna
authors.initials: J
authors.lastname: Kirby
mesh_terms: D000367:Age Factors; D015992:Body Mass Index; D002648:Child; D002662:Child Health Services / Q000191:economics*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004032:Diet / Q000009:adverse effects; D004739:England; D015444:Exercise; D005247:Feeding Behavior; D017048:Health Care Costs; D006792:House Calls; D006801:Humans; D008603:Mental Health; D009765:Obesity / Q000175:diagnosis / Q000191:economics / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D010287:Parent-Child Relations; D016487:Parenting; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012107:Research Design; D040242:Risk Reduction Behavior; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss