Abstract
OBJECTIVE: Evaluating effectiveness and cost-effectiveness of 'Families for Health V2' (FFH) compared with usual care (UC). DESIGN: Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families. SETTING: Three National Health Service Primary Care Trusts in West Midlands, England. PARTICIPANTS: 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. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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. TRIAL REGISTRATION NUMBER: ISRCTN45032201.