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

Abstract

ObjectiveEvaluating effectiveness and cost-effectiveness of ‘Families for Health V2′ (FFH) compared with usual care (UC).DesignMulticentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families.SettingThree National Health Service Primary Care Trusts in West Midlands, England.ParticipantsOverweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6–11 years and their parents/carers, recruited March 2012–February 2014.InterventionsFFH; 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 measuresPrimary 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.Results115 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.ConclusionsFFH was neither effective nor cost-effective for the management of obesity compared with UC.Trial registration numberISRCTN45032201.

Utility values for childhood obesity interventions: a systematic review and meta‐analysis of the evidence for use in economic evaluation

“…The study by Robertson et al . evaluated the effectiveness and cost‐effectiveness of a community‐based programmatic intervention. Data on utility values were collected at baseline, 3 months and 12 months using the EQ‐5D‐Y based on both child self‐report and parental proxy.…”

“…No additional papers were identified from the reference lists of included studies or the Paediatric Economic Database Evaluation database. A total of 11 studies were included in our review, nine health state valuation studies eliciting primary utility values (35)(36)(37)(38)(40)(41)(42)(43)(44) and two economic evaluations (45,46).…”

Cost-Effectiveness of an Obesity Management Program for 6- to 15-Year-Old Children in Poland: Data from Over Three Thousand Participants

“…On the other hand, an RCT, which analyzed the effectiveness of a program aimed at strengthening parental competence in order to improve the lifestyle of the whole family, showed a lack of clinical and cost effectiveness. Robertson et al [31] demonstrated that not only did the weight parameters of the children from the study group not significantly improve in relation to the control group but in some of them the indicators deteriorated. For example, the average BFP of 36.81% at the starting point reached 37.58% after 12 months of the program.…”

Is there an association between early weight status and utility-based health-related quality of life in young children?

“…While there are a number of studies that have reported health utility values for children with overweight and obesity [13][14][15][16][17][18][19][20][21][22], this is the first study to investigate the association between weight status during preschool years and preference-based HRQoL outcomes at 5 years, the youngest age recommended for use with the HUI instrument [32]. Given the limited published evidence regarding pediatric health-related utilities, our study makes a useful contribution by providing further evidence of a non-significant association between weight status and preferencebased HRQoL outcomes in preschool children.…”

“…However, only a few studies have used preference-based instruments to measure HRQoL and there is no consensus among them regarding the impact of weight status on HRQoL in children and adolescents. For example, some studies have found statistically significant poorer HRQoL in school-age children and adolescents with overweight or obesity [13][14][15], while others found no association [16][17][18][19][20][21][22]. In studies where 5-year old children have been examined, they were grouped together with older children as a cohort [17,20] or had already started primary school [19].…”