A randomised controlled trial to test the clinical and cost-effectiveness of primary care referral to a commercial weight loss provider.

Overweight and obesity is a serious public health issue due to its high prevalence and association with illnesses, such as Type II diabetes, heart disease and cancer. Early treatment and prevention are important if we are to reduce the health problems associated with excess weight, but there are few treatments available through the National Health Service (NHS) and those that are available can be very costly when we consider the number of people requiring treatment. It is in the interests of the NHS to offer (cost-effective) weight loss treatment options, as they spend £4.2 billion each year on treating illness related to overweight and obesity. The cost to the wider community is estimated at £16 billion. This study seeks to examine one of the treatment options currently available on the NHS - referral to a commercial weight loss treatment provider - and to establish whether this treatment option is cost-effective in helping people to lose weight and keep it off.
Previous research has shown that referring a patient for 12 sessions with a commercial weight loss provider can produce an amount of weight loss which has significant health benefits. These referral packages are offered to the NHS at a discounted price, however no studies have formally evaluated the cost-effectiveness of this approach. This study will examine whether the money spent on treatment is worthwhile when we consider the effect of improved health for patients and also potential cost savings on treatments for weight-related illness. But weight regain is common after weight loss treatment stops and it may be that 12 weeks is not long enough to develop long term changes in behaviour. It is not hard to imagine that a 12 month referral could lead to greater weight loss and more long term changes than a 12 week programme, and that this could mean less weight regain. However, the likely increased effect will come at a higher cost, leaving the question 'What is the more cost-effective option?'. This isrecisely what this study seeks to examine. We also want to uderstand more about the patient experience of weight loss treatment. Previous research has shown that many adults with overweight and obesity do not consider this to be a medical problem and this may influence their attitudes to receiving treatment through the NHS. By improving our understanding of attitudes and experience of treatment, we can improve the way weight management is provided by the NHS.
In our trial, 1200 adults with overweight and obesity will be identified by their GP and recruited by the research team. The research team will randomly assign participants to one of three treatment groups - a 12 session referral to a commercial provider, a 12 month referral to a commercial provider, or a 'brief intervention' (standard information about how to lose weight and weighing at follow up). We will follow participants up at 3 months, 12 months and 24 months (1 year after treatment has finished) to compare the amount of weight lost by participants in each group. We will also look at how many participants in each group lose an amount of weight that is associated with significant health improvements. We will use this and other data collected during the trial to examine which treatment option offers the best value for money. This will be examined over the short term (the duration of the trial) and the longer term, using long term modelling of anticipated health changes and associated costs. We will also interview a subset of participants to gain a more holistic view of the patient experience and to explore their attitudes to weight loss treatment and NHS-commercial partnerships.
This research will provide important information to GPs and NHS treatment commissioners about which treatment option is most effective and which offers best value for money. Trial results and findings from interviews will help inform future decisions about NHS-commercial partnership

The prevalence of adult overweight and obesity and the associated burden of disease put increasing pressure on NHS resources. There is urgent need for treatment options that are clinically and cost-effective and deliverable at scale in primary care. Recent trials demonstrate the acceptability and short term efficacy of primary care referral to a commercial weight loss provider. NHS commissioners now need information on the optimal duration of intervention and the longer term outcomes and cost effectiveness of such treatment to give best value for money. The proposed 2 year randomised controlled trial will evaluate the clinical and cost effectiveness of 3 weight loss interventions that can be delivered in primary care (referral to a commercial weight loss provider (Weight Watchers; WW) for 12 weeks; referral to WW for 12 months; or a brief intervention that consists of standard information and periodic weighing with feedback). Participants will be 1200 adults (BMI >28kg/m2; Age>18years) identified by their GP as likely to benefit from weight loss. Participants attend assessments with the research team at 0, 3, 12 and 24 months. Main outcomes for evaluation of clinical effectiveness will be changes in weight, fat mass, and blood pressure, and the primary analysis will be an intention to treat analysis of differences between treatments. Secondary analyses will include a completers only analysis and the proportion of all participants and completers losing 5% or more of initial weight. Data will also be collected on quality of life and health care usage over the two year period to evaluate cost-effectiveness. A within-trial and long term cost-effectiveness analysis will be conducted from an NHS perspective. Qualitative methods will be used to examine experiences of patients and practitioners involved in the trial and their attitudes to NHS partnerships with the commercial sector. Findings will help practitioners and commissioners make decisions about treatment provision.

It is anticipated that by improving the evidence base for primary care weight loss treatment, findings will help improve weight loss treatment provision in the UK NHS, thus having a direct benefit for patient and population health and quality of life. The impact of this study is not limited to the UK. Overweight and obesity is a global problem and these data will also inform international interest in obesity treatment provision and contribute to the UK role as a leader in obesity treatment and primary health care research. However, NHS commissioners will benefit from robust evidence on the effectiveness and cost-effectiveness of commercial weight loss treatment, enabling them to make better informed decisions about treatment provision and the allocation of resources. The trial should also inform debate about the nature of NHS-commercial partnerships at a national level and will be relevant to discussions around the Government Responsibility Deal for public health. Practitioners will benefit from better evidence on which to base treatment decisions, and in time will perhaps benefit from better choice and availabity of treatment options and referral pathways. Findings should also illuminate the optimal implementation of treatment provision. Disseminating the findings of this study will provide opportunities to open up a dialogue with the public on the role of health professionals and commercial providers in weight management.
The commercial treatment provider involved in the research may benefit from heightened profile and increased business through the NHS. Other commercial treatment providers may also benefit from a stronger evidence base for commercial referral and findings could potentially increase collaborative relationships with the National Health Service. We hope that this trial will strengthen the precedent for robust, independent evaluation of commercial programmes, encouraging responsible involvement of commercial companies in scientific research.
The research team will all benefit from the opportunity to collaborate on this research and share knowledge and expertise across research centres. Involvement in the trial will offer a platform for developing new interdisciplinary research networks, with the intention that these will lead to further research collaborations. This grant will specifically improve the career trajectories of the Principal Investigator and the Trial Manager. The Principal Investigator has experience of running similar trials and coordinating scientific studies. As PI on this grant she will be able to formally demonstrate her abilities as an independent researcher, with mentoring from Dr Jebb as line manager and coapplicant. The Trial Manager has received considerable training in the necessary skills of trial management and already has some experience of trial management. This study will provide a challenging but nurturing environment in which to put these skills into practice and give her the experience and further training/mentoring needed for her to progress to the next grade and make a transition from research support to trial manager.