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The Families for Health programme focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family and to help children manage their weight. Within the care pathway for weight management services, Families for Health is a level 2 targeted weight management service.8The logic model97shown inFigure 24was developed prior to analysis of

data, to demonstrate how the Families for Health intervention is intended to work.

In this RCT there was no statistically significant difference in the change in BMI z-score at the 12-month follow-up between the usual-care and Families for Health arms (0.114, 95% CI–0.001 to 0.229;p=0.053; model 1). However, the within-group analysis showed that BMI z-score was significantly reduced in the usual-care arm (–0.118, 95% CI–0.203 to–0.034;p=0.007), whereas there was no significant change in the Families for Health arm (–0.005, 95% CI–0.085 to 0.078;p=0.907). The measurements of waist circumference z-scores and percentage fat are consistent with the BMI findings. This indicates a trend that children allocated to the Families for Health arm did worse than children randomised to the usual care available locally at the three sites in terms of the management of their obesity.

Apart from a significant improvement in activity level in parents44in the usual-care arm compared with the

Families for Health programme, there were no other significant differences between groups for the other secondary outcome measures (objective or self-reported). Children’s quality of life, parents’well-being and the child–parent relationship scores were all better (but not significantly different) in the Families for Health group than in the usual care group. Thus, there is some indication that the Families for Health programme may have influenced parenting and family relationships, as predicted in the logic model, although the BMI z-score change was worse than in the usual-care group.

Other studies focusing on the treatment of obesity using a parenting approach have found mixed results. Lifestyle Triple P (Positive Parenting Program®, University of Queensland, Brisbane, QLD, Australia) is a

general parenting programme that is aimed at lifestyle, targeting parents of overweight and obese children, from which contrasting results have emerged. In a RCT in children aged 4–11 years in Australia,

Parents more able to implement changes in child’s

lifestyle authoritatively

Child more receptive Child more self-aware

and confident

BMI falls FFH

Parent and child more knowledgeable about causes of obesity and how to support

physical activity/healthy eating

Parents more self-aware and confident Parenting skills developed

BMI z-score in the Lifestyle Triple P group was lower by–0.11 at the end of the 12-week programme and by–0.19 at 1-year follow-up, compared with a reduction of–0.01 in the wait-list control group (who then started the intervention at 12 weeks).98However, a study in the Netherlands of overweight and obese

children aged 4–8 years found no significant intervention effects in children’s BMI z-score, waist circumference or skinfold thickness between Lifestyle Triple P and the control intervention (comprising printed material) at 4 and 12 months after baseline.99In general, replication studies of the Triple P suite of

programmes have shown less effect than observed in the original trials,100and in this case there was also a

difference in the control intervention between these two trials, with the wait-list control trial showing more effect. A systematic review of general parenting interventions to prevent or treat childhood obesity, which included the Triple P study by Westet al.98and the Families for Health pilot study,24found only limited

evidence but did find a small positive effect on weight-related outcomes.16

Economic evaluation

Not only was Families for Health less effective than usual care in terms of BMI z-score, it was also significantly more costly to deliver. The increased costs were mainly because the Families for Health programme ran separate parallel groups for parents and children with two facilitators in each, whereas the group-based interventions in the usual-care arm were delivered with parents and children attending the same group. The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained, and the probability that Families for Health is cost-effective at a £20,000 cost-effectiveness threshold is approximately 28%. When health outcomes were measured in terms of longitudinal change in BMI z-score, the mean incremental cost-effectiveness of Families for Health was estimated at–£3935 per unit change in BMI z-score (indicating that, on average, Families for Health is dominated by usual care in health economic terms) and the probability that the Families for Health programme is cost-effective does not exceed 2% across a range of cost-effectiveness thresholds. These findings leave little doubt that the Families for Health programme is not a cost-effective intervention.

Process evaluation

An uncontrolled pilot study of the Families for Health programme had demonstrated proof of principle for the programme showing a long-term reduction in BMI z-scores,24,25so a question to be answered by the

process evaluation is whether the lack of effectiveness of the Families for Health programme in this trial was because of the intervention itself or poor implementation.86Problems with implementation that could

have impacted on effectiveness included issues with recruiting a sufficient number of families to form viable Families for Health groups (minimum of eight families) at each site. Recruitment to group-based interventions is more challenging than to one-to-one interventions and becomes doubly so in the context of a trial, as approximately half of the families recruited were randomised to the usual-care intervention. This meant that many families had to wait more than 3 months to receive the Families for Health

intervention. Furthermore, some programmes were delivered with an insufficient number of families some weeks, owing to a combination of starting a group with a relatively small number recruited and low attendance, impacting on effectiveness. However, based on the quantity and quality of what was delivered, the process evaluation indicates that the intervention was implemented reasonably well, probably as well as could be expected if the programme were to be scaled up further. There were no major adaptations across the seven programmes and where activities were replaced or modified, the original aims of the handbook activity were upheld. This supports a conclusion that the Families for Health programme was delivered as planned or as well as would be possible when scaled up over three sites, and is ineffective at reducing BMI z-score.

The process evaluation indicates that the majority of families had a positive experience and found the Families for Health programme useful and enjoyable. This was particularly so in relation to food topics, with an increased knowledge and understanding of food labelling being documented. The opportunity to

take part in various forms of physical activity, particularly gym sessions, was valued by both parents and children. Parents also felt that they gained a lot from meeting other parents facing similar challenges. It is important to acknowledge these aspects of the Families for Health programme that were perceived to work well. These could be built on in new interventions to tackle childhood obesity.

Our over-riding conclusion from the Families for Health trial is that the combining of support for parenting and family relationships with learning about healthy eating and physical activity in this intervention did not help families manage their children’s overweight or obesity, at least in the medium term.