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JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Randomised controlled trial and economic evaluation of the 'Families for Health' programme to reduce obesity in children

Wendy Robertson, Joanna Fleming, Atiya Kamal, Thomas Hamborg, Kamran A Khan, Frances Griffiths, Sarah Stewart-Brown, Nigel Stallard, Stavros Petrou, Douglas Simkiss, Elizabeth Harrison, Sung Wook Kim, Margaret Thorogood
Archives of Disease in Childhood 2017, 102 (5): 416-426
28003178

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.

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