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).

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.

Keywords: Evidence Based Medicine; Nutrition; Obesity; Parenting.

Figure 1

CONSORT flow diagram of Families for Health randomised controlled trial.

Figure 2

Change over time for primary outcome body mass index (BMI) z-score (unadjusted means and CIs). FFH, Families for Health; UC, usual care.

Figure 3

Cost-effectiveness plane (A) and cost-effectiveness acceptability curve (B) for quality-adjusted life-year gained (QALY) outcome; complete cases from the National Health Service and PSS perspective.