Robertson Wendy, Fleming Joanna, Kamal Atiya, Hamborg Thomas, Khan Kamran A, Griffiths Frances, Stewart-Brown Sarah, Stallard Nigel, Petrou Stavros, Simkiss Douglas, Harrison Elizabeth, Kim Sung Wook, Thorogood Margaret
Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
Arch Dis Child. 2017 May;102(5):416-426. doi: 10.1136/archdischild-2016-311514. Epub 2016 Dec 21.
Evaluating effectiveness and cost-effectiveness of 'Families for Health V2' (FFH) compared with usual care (UC).
Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families.
Three National Health Service Primary Care Trusts in West Midlands, England.
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.
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.
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.
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.
FFH was neither effective nor cost-effective for the management of obesity compared with UC.
ISRCTN45032201.
评估“健康家庭V2”（FFH）相较于常规护理（UC）的有效性和成本效益。
多中心随机对照试验（RCT）（研究者设盲，家庭未设盲）及经济评估。按家庭分层随机分组；目标为120个家庭。
英格兰西米德兰兹郡的三个国民健康服务初级保健信托基金。
2012年3月至2014年2月招募的6至11岁超重或肥胖（体重指数（BMI）≥第91或≥第98百分位数）儿童及其父母/照料者。
FFH；一项为期10周的基于社区的家庭计划，涉及育儿、生活方式改变以及社会和情感发展。UC；各站点对儿童肥胖的常规支持。
主要结局为儿童BMI z评分的12个月变化以及每获得一个质量调整生命年（QALY）的增量成本。次要结局包括儿童身体活动、水果和蔬菜摄入量及生活质量的变化，父母的BMI和心理健康状况，家庭饮食/活动、亲子关系及育儿方式。
115个家庭（128名儿童）被随机分为FFH组（n = 56）或UC组（n = 59）。12个月时BMI z评分变化无显著差异（0.114，95%置信区间 -0.001至0.229，p = 0.053；采用缺失值多重填补法时p = 0.026，UC组更优）。一项次要结局，即儿童腰围z评分变化，两组间存在显著差异，UC组更优（0.15，95%置信区间0.00至0.29）。经济评估显示，FFH的平均成本显著高于UC（998英镑对548英镑，p < 0.001）。FFH的平均增量成本效益估计为每QALY 552,175英镑。
与UC相比，FFH在肥胖管理方面既无效果也无成本效益。
ISRCTN45032201。
