Robertson, Wendy, Fleming, Joanna, Kamal, Atiya, Hamborg, Thomas, Khan, Khalid Saeed, Griffiths, Frances, Stewart-Brown, Sarah L., Stallard, Nigel, Petrou, Stavros, Simkiss, Douglas E., Harrison, Elizabeth, Kim, S. W. and Thorogood, Margaret (2017) Randomised controlled trial and economic evaluation of the ‘Families for Health’ programme to reduce obesity in children. Archives of Disease in Childhood, 102 (5). pp. 416-426. doi:10.1136/archdischild-2016-311514 ISSN 0003-9888.

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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.

Item Type:	Journal Article
Subjects:	R Medicine > RJ Pediatrics > RJ101 Child Health. Child health services
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Obesity in children -- Prevention -- Great Britian, Clinical trials, Obesity in children -- Economic aspects -- Great Britian
Journal or Publication Title:	Archives of Disease in Childhood
Publisher:	BMJ
ISSN:	0003-9888
Official Date:	19 April 2017
Dates:	Date Event 19 April 2017 Published 21 December 2016 Available 15 November 2016 Accepted 27 June 2016 Submitted
Volume:	102
Number:	5
Page Range:	pp. 416-426
DOI:	10.1136/archdischild-2016-311514
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Date of first compliant deposit:	26 January 2017
Date of first compliant Open Access:	26 January 2017
Funder:	National Institute for Health Research Health Technology Assessment (Great Britain) (NIHR HTA)
Grant number:	09/127/41.

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