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

Lead Research Organisation: MRC Human Nutrition Research Group

Abstract

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 is precisely 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

Technical Summary

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.

Planned Impact

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.
 
Description Briefing for DH Permanent Secretary
Geographic Reach National 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
Impact Informed development of government obesity strategy
 
Description Evidence/ Interview for NIHR Dissemination Centre
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
URL http://www.dc.nihr.ac.uk/highlights-and-reviews/obesity-in-men/feature-pages/what-motivates-men-to-l...
 
Description Invited lecture and run table discussion with Department of Health, Canberra, Australia
Geographic Reach Australia 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
Impact Consideration given to possibility of implementing new schemes to offer behavioural weight management interventions as central part of new chronic disease management pathway
 
Description No 10 Round-table on obesity
Geographic Reach National 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
Impact Discussions informed development of obesity strategy
 
Description Public Health England Obesity Review Board
Geographic Reach National 
Policy Influence Type Implementation circular/rapid advice/letter to e.g. Ministry of Health
 
Description Funding for collection and analysis of blood samples
Amount £186,000 (GBP)
Organisation Weight Watchers International 
Sector Private
Country United Kingdom of Great Britain & Northern Ireland (UK)
Start 09/2013 
End 09/2015
 
Description EMA CASE Studentship (Liverpool) 
Organisation University of Liverpool
Department School of Psychological Sciences
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Contribution to study design and funding application. Co-supervision of student.
Collaborator Contribution Led study design and funding application. Primary supervision of student.
Impact NWDTC ESRC CASE Studentship at University of Liverpool
Start Year 2013
 
Description Scalable Behavioural Weight Management Interventions for Diabetes 
Organisation Cauldron Group Inc.
Country United States of America 
Sector Private 
PI Contribution Led the development of a 5-year programme of research on the development and evaluation of scalable behavioural interventions for the prevention and treatment of diabetes.
Collaborator Contribution ScHARR led the development on the economic modelling component of this programme of research University of Leeds contributed expertise on the development of weight management interventions Weight Watchers International will provide interventions that will be evaluated Oviva will provide interventions that will be evaluated Cauldron will support the development of a neww intervention Cambridgeshire and Peterborough CCG will support recruitment of participants and the collection of data, delivery of control interventions, and patient and stakeholder engagement. NHS North Norfolk CCG will support patient and public engagement and stakeholder engagement.
Impact NIHR PGfAR award
Start Year 2016
 
Description Scalable Behavioural Weight Management Interventions for Diabetes 
Organisation NHS Cambridgeshire and Peterborough CCG
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Led the development of a 5-year programme of research on the development and evaluation of scalable behavioural interventions for the prevention and treatment of diabetes.
Collaborator Contribution ScHARR led the development on the economic modelling component of this programme of research University of Leeds contributed expertise on the development of weight management interventions Weight Watchers International will provide interventions that will be evaluated Oviva will provide interventions that will be evaluated Cauldron will support the development of a neww intervention Cambridgeshire and Peterborough CCG will support recruitment of participants and the collection of data, delivery of control interventions, and patient and stakeholder engagement. NHS North Norfolk CCG will support patient and public engagement and stakeholder engagement.
Impact NIHR PGfAR award
Start Year 2016
 
Description Scalable Behavioural Weight Management Interventions for Diabetes 
Organisation North Norfolk Clinical Commissioning Group
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Public 
PI Contribution Led the development of a 5-year programme of research on the development and evaluation of scalable behavioural interventions for the prevention and treatment of diabetes.
Collaborator Contribution ScHARR led the development on the economic modelling component of this programme of research University of Leeds contributed expertise on the development of weight management interventions Weight Watchers International will provide interventions that will be evaluated Oviva will provide interventions that will be evaluated Cauldron will support the development of a neww intervention Cambridgeshire and Peterborough CCG will support recruitment of participants and the collection of data, delivery of control interventions, and patient and stakeholder engagement. NHS North Norfolk CCG will support patient and public engagement and stakeholder engagement.
Impact NIHR PGfAR award
Start Year 2016
 
Description Scalable Behavioural Weight Management Interventions for Diabetes 
Organisation University of Leeds
Department School of English
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Academic/University 
PI Contribution Led the development of a 5-year programme of research on the development and evaluation of scalable behavioural interventions for the prevention and treatment of diabetes.
Collaborator Contribution ScHARR led the development on the economic modelling component of this programme of research University of Leeds contributed expertise on the development of weight management interventions Weight Watchers International will provide interventions that will be evaluated Oviva will provide interventions that will be evaluated Cauldron will support the development of a neww intervention Cambridgeshire and Peterborough CCG will support recruitment of participants and the collection of data, delivery of control interventions, and patient and stakeholder engagement. NHS North Norfolk CCG will support patient and public engagement and stakeholder engagement.
Impact NIHR PGfAR award
Start Year 2016
 
Description Scalable Behavioural Weight Management Interventions for Diabetes 
Organisation Weight Watchers International
Country United Kingdom of Great Britain & Northern Ireland (UK) 
Sector Private 
PI Contribution Led the development of a 5-year programme of research on the development and evaluation of scalable behavioural interventions for the prevention and treatment of diabetes.
Collaborator Contribution ScHARR led the development on the economic modelling component of this programme of research University of Leeds contributed expertise on the development of weight management interventions Weight Watchers International will provide interventions that will be evaluated Oviva will provide interventions that will be evaluated Cauldron will support the development of a neww intervention Cambridgeshire and Peterborough CCG will support recruitment of participants and the collection of data, delivery of control interventions, and patient and stakeholder engagement. NHS North Norfolk CCG will support patient and public engagement and stakeholder engagement.
Impact NIHR PGfAR award
Start Year 2016
 
Description Association for the Study of Obesity Annual Meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presentation of a series of studies including two NPRI funded projects about weight management in primary care.
Year(s) Of Engagement Activity 2016
 
Description Institute of Child Health Seminar series 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Talk on weight management in primary care
Year(s) Of Engagement Activity 2014
 
Description Keynote address at UK Society for Behavioural Medicine 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact This was a keynote presentation to a key audience of colleagues who work in similar ways in which I described the mechanisms underlying the effect of the intervention on behaviour and what that tells us about treatment.
Year(s) Of Engagement Activity 2016
URL https://www.kc-jones.co.uk/uksbm2016
 
Description Liverpool Postgraduate Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Invited Keynote presentation at Liverpool School of Psychology Postgraduate Research Student Conference, attended by 25 PhD canditates and supervisors. Led to questions and discussion about the research and attendees reported an increased interest in doing multi-disciplinary research in public health.

Feedback from several students that presentation had inspired them to think about how their work could be applied to public health problems and to consider a career in applied research.
Year(s) Of Engagement Activity 2013
 
Description Participant Newsletters 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Study participants or study members
Results and Impact Participants are all sent newsletters which gave them more information about the trial, who was taking part, the trial team, the goals of the research, and preliminary results. This increased participant retention in the WRAP trial and encouraged participants to stay engaged in research.

Participant retention in the WRAP trial increased and some participants attributed this to the newsletter.
Year(s) Of Engagement Activity 2013,2014,2015,2016
 
Description Presentation at PCRN National Team Meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Shared experience of recruitment phase of trial with PCRN members, GPs and practice staff from across the country as part of a workshop aimed at sharing best practice and improving service provision. Led to increased interest in participating in this type of research, and sharing of ideas to make it easier to conduct this type of research.

Prompted considerable discussion on the challenges of conducting obesity research in primary care and what the PCRN might do to try and overcome such challenges. Several network members expressed interest in participating in this kind of research in the future.
Year(s) Of Engagement Activity 2013
 
Description Richard Doll Seminar Series 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other audiences
Results and Impact Talk on "New evidence from trials to inform the management of obesity in routine care"
Audience of about 150

In following week, two doctors spontaneously reported that they had changed their practice and made a brief intervention for weight management with a patient
Year(s) Of Engagement Activity 2016
 
Description Society for Academic Primary Care 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presentation of results from NPRI funded trial to primary care practitioners
Year(s) Of Engagement Activity 2016
 
Description Talk to Glasgow University 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Other audiences
Results and Impact In this talk I presented our research on weight management and what it has achieved.
Year(s) Of Engagement Activity 2017
 
Description Thames Valley Strategic Clinical Network Conference 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact A regional event to promote service innovation by learning from research. Presented new findings primarily from NPRI funded studies on weight management in adults. Evaluation forms found it to be the most highly rated presentation on the day with some reporting intention to change practice. Asked by regional Medical Director to do a video interview, subsequent webinar for local commissioners and speak at follow up event..
Year(s) Of Engagement Activity 2016
 
Description The Obesity Society 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation at The Obesity Society conference. Raised profile of trial and findings with international scientists, practitioners and policy makers.
Year(s) Of Engagement Activity 2016
 
Description The Osler Lecture - Oxford medical Alumni 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact A presentation to an alumni group of about 200 people, including many current medical practitioners. I received 4 or 5 emails subsequently requesting additional information and notes reporting a new awareness about the success of weight-loss interventions offered by health professionals with some correspondents specifically noting this would info;hence their practice.
Year(s) Of Engagement Activity 2016
 
Description UK Society for Behavioural Medicine 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presentation on 24 month outcomes. Raised profile of trial and findings at a National level.
Year(s) Of Engagement Activity 2016
 
Description Working with Public Health England to develop training for practitioners in weight management 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Public Health England are developing resources to help practitioners raise the issue of overweight and obesity with patients and train them in what to do. The brief intervention component is based on BWeL and the use of referral to weight management services is based on the WRAP trial. We are having regular phone conferences and editing the materials.
Year(s) Of Engagement Activity 2016,2017