Title: How are treatment outcomes for people with severe obesity ImPROved by GROUP-based behavioural intervention?
Funder: Department of Health and Social Care

Abstract: Background Severe obesity (Body Mass Index >35kg/m2) affects approximately 5 million people in the UK, shortens life expectancy and is a risk factor for many health problems. Annually, obesity costs the NHS &pound;2.5-5.1 billion. The NHS commissions specialist ( Tier 3 ) clinics for lifestyle management of severe obesity but the challenge is how to deliver these effectively and efficiently, particularly with rising demand. Group-based interventions may help respond to this challenge. Research question This 5-year programme addresses questions concerning: (i) feasibility of a group-based intervention for people with severe obesity (PWSO); (ii) (cost-) effectiveness of, and (iii) mechanisms underpinning, group-based interventions for PWSO; (iv) service implementation of such interventions. Aims and objectives To test an evidence-based group intervention ( PROGROUP ) for reducing weight in PWSO. Specific objectives are to: Refine the PROGROUP intervention, and the logic model and implementation strategy which underpin it Assess feasibility and acceptability of PROGROUP and proposed trial methods Test whether PROGROUP is more effective than usual care, in terms of supporting weight loss and other health outcomes Evaluate PROGROUP cost-effectiveness and mechanisms of action Determine how best to implement PROGROUP. Overall design Three linked work-packages (WPs) will refine the intervention and its logic model; assess the delivery feasibility and methodology for, and then conduct, a definitive randomised controlled trial; finalise and disseminate the implementation strategy. Patient and public involvement (PPI) The research programme is underpinned by extensive PPI work. Patients and other stakeholders (health care professionals, service managers) will be involved throughout, including in the project dissemination. WP1: Preparing for delivery of group-based intervention in Tier 3 settings Advisory group consultations Realist evaluation of logic model Assemble intervention manual and training programme Finalise the outcome measure set Finalise sites and permissions Map baseline resource use in trial sites WP2: Assessing feasibility Two-arm randomised feasibility study of PROGROUP in three sites to explore common feasibility concerns and intervention processes, and confirm health (economic) outcome measures Decide whether or not to progress to definitive trial WP3: Assessing effectiveness and cost-effectiveness Final procedures and parameters will be based on WPs1-2. Current proposal: Pragmatic, superiority, individually randomised controlled trial (N=1,100), delivered in 10 sites Parallel process and health economic evaluation Finalisation of implementation strategy Dissemination Dissemination will be structured using NIHR s Push the Pace guidance and dissemination template, and will include: An end-of-project stakeholder event to share new guidance on implementing group-based intervention in Tier 3 services Dissemination to national and international health care professionals through stakeholder organisations (including the Association for the Study of Obesity) Peer-reviewed publications and conference presentations Anticipated impact Anticipated short, medium, and long-term benefits for patients and the NHS include: Short: Enhancing patient engagement with group-based care; production of guidelines for optimising Tier 3 services Medium: Weight loss necessary to bring about health benefits in a greater proportion of patients; trained facilitators demonstrating competence in running groups Long: Weight loss maintenance and sustained behaviour change; consistency in provision and improved cost effectiveness of NHS Tier 3 care.

Lay abstract: Background to the research Approximately 25 million UK adults are overweight and another 15 million are obese, moreover, about 5 million adults are severely obese and 1.5 million middle-aged adults extremely obese. These problems are worse in deprived communities and minority groups. Severe obesity reduces life expectancy due to potential development of diabetes, heart disease and cancer. People with severe obesity also report greatly impaired quality of life. One treatment option is weight-loss surgery, but few people choose this, and other treatment options are limited. The NHS provides specialised weight management services for people with severe obesity, but what these Tier 3 clinics do, and how effective they are is unclear. Our project seeks to better understand these clinics and investigate whether a new facilitator-led, intensive, group-based behavioural programme (PROGROUP) is more effective and less costly than usual care for people with severe obesity. Aim of the research The aim is to adopt best practice for group based treatment in Tier 3 weight management and to establish whether PROGROUP is in fact more effective and less costly than NHS usual care. Design and methods 1. Initially we will run test groups to establish if PROGROUP will work on a larger scale, following which we will randomly allocate recruited patients to the new service if they are willing to be involved in the study. This stage will include 120 patients at three clinics, receiving weight management services, with or without the new group programme. If successful we will move to a large trial in the final stage. 2. The large scale study will take place in 10 centres around the UK involving 1,100 patients. After 12 months we will measure weight loss, cost-effectiveness of treatment, and other impacts that patients say are important to them. We will then compare the PROGROUP programme to the old service. Patient and public involvement We have formed a patient and public consultation group which will be central to developing and setting-up PROGROUP, and in identifying the impacts from the trial that are most relevant to patients. Dissemination Our findings as to delivery of successful services that meet patients' needs will be shared regionally, nationally and internationally with the help of the patient expert consultation group. We will do this through weight management groups we have worked with and our many stakeholders &ndash;including Association for the Study of Obesity, British Dietetic Association, commissioners and NHS England. The results will also be published by press releases, newsletters, social media and in health journals.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: ORAL AND GASTROINTESTINAL;METABOLIC AND ENDOCRINE;STROKE;CANCER AND NEOPLASMS;CARDIOVASCULAR