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.
- Evidence Based Medicine
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Contributors WR had overall responsibility for the study as the Chief Investigator. SS-B, SP, NS, MT, FG and DS were co-applicants on the grant application and were involved in its implementation. JF, AK, EH and WR were responsible for the recruitment to the trial, and EH was responsible for assigning participants to their allocated intervention. JF, AK and WR carried out the fieldwork with families and facilitators. JF, AK, FG, MT and WR analysed the qualitative data; TH and NS analysed the quantitative data and KK, SWK and SP carried out the economic analysis. All authors have been actively involved in the authorship of the paper and approved the final manuscript.
Funding Health Technology Assessment Programme (09/127/41).
Disclaimer The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Health Technology Assessment programme, National Institute for Health Research, National Health Service or the Department of Health.
Competing interests None declared.
Ethics approval Committee West Midlands—Coventry and Warwickshire REC (reference 11/WM/0290).
Provenance and peer review Not commissioned; externally peer reviewed.