Development and stage 2 RCT with internal pilot of a weight loss maintenance intervention for obese adults after clinically significant weight loss

Lead Research Organisation: Newcastle University
Department Name: Inst of Health and Society

Abstract

Obesity is a major problem worldwide, with 1 out of 4 adults being obese in the UK. Obesity is strongly related to chronic illnesses, sickness absence from work and reduced life expectancy. Weight problems costs the UK economy £16 billion a year. The NHS and the public invest considerably in weight loss treatments, but most people who are successful in losing weight quickly regain the weight they lost. Helping people not to regain weight after successful weight loss is vital in tackling the obesity epidemic.
In stage 1, we will develop a weight loss maintenance intervention for adults who were previously obese but who have lost at least 5% of their body weight in the previous 6 months. The intervention will be based on evidence from a comprehensive review of the research literature and will use techniques and theory of behaviour change which have been used in previously effective interventions. After an initial face-to-face meeting for advice and to set personal goals, participants will receive pedometers and body weighing scales which communicate data wirelessly to a central server. They will be asked to weigh themselves every day and will be prompted by text message reminder if they forgot to do so for more than one day. Weighing and weight data will be received immediately by a central server and this will trigger the delivery of automated intervention content which has been individually tailored based on the recorded weight The intervention will provide 'light touch' daily support in periods of successful weight loss maintenance, and will become more intensive of periods of weight regain.
The details of the intervention content, hardware and software will be developed in the first year using in consultation with potential users and building on the complementary expertise of our research team and the evidence from our systematic review. In addition, we will conduct a series of small pilot studies so that we can learn how to make the intervention as acceptable,possible and easy to use as possible.
In stage 2 we will recruit 288 initially obese adults after weight loss and then and randomly place them to receive either the new intervention (test) or not (a control) for six months. We will follow the participants for 12 months to test if weight regain differs between both the two groups. We will measure body weight, and other aspects related to body composition, physical activity and psychological aspects before people are allocated to each group and again 12 months later. Use of services and participant costs will be measured over the 12 month follow-up period.
To ensure that the procedures for identification/recruitment, allocation and measurement are possible and acceptable to participants we have specified a set of criteria and additional assessments based on the first three months of recruitment and first 60 participants which check if the procedures are appropriate to recruit and retain 288 trial participants within a two year period. If these pre-set targets are not met, we will consult the funder and our independent Trial Steering Committee and seek advice to either discontinue the trial or change the procedures. If the pre-set targets are met, we will continue the study and the pilot data will form part of the final trial data set. The inclusion of an internal pilot study like this provides better value for money than conducting a standalone pilot study over a relevant period for WLM and will also allow us to obtain evidence for effectiveness much more rapidly than the traditional approach of a standalone pilot would.
In addition to the standard procedures for analysing the outcomes of a randomised trial, part of the trial will be an economic evaluation which will explore the value for money of the intervention. We will also explore the relationships between socio-economic status and other participant characteristics with weight loss maintenance.

Technical Summary

The NHS and the public invest considerably in weight loss interventions but most people regain weight rapidly. We propose developing the first WLM intervention meeting the MRC guidance for the development of complex interventions, based on evidence identified from a systematic review and configured through user-centred design. We will conduct the first UK based WLM RCT and the first such RCT conducted in Europe to recruit individuals in the community. The proposed intervention will combine automated intervention content provided through personal body weighing scales which communicate data wirelessly to a central server and tailored intervention content delivered through a mobile internet platform and personal contact. The detailed procedures of the intervention content, hardware and software will be developed in the first year using user-centred design and the evidence from our systematic review. We will conduct a series of small pilot studies to optimise acceptability and feasibility of the intervention.
We will then conduct a two-arm RCT with randomisation of 144 participants each to the new intervention or a control condition with assessment of body weight and secondary outcomes prior to randomisation and one year later. Qualitative process evaluation will be conducted with 20 participants in both groups. We will integrate an 'internal pilot' into the trial to test in the first three months and with the first 60 participants if the trial procedures are feasible. If pre-set targets are not met, we will seek advice from the funder and the independent Trial Steering Committee about either discontinuing the trial or modifying the procedures. If these targets are met, we will continue the study and the pilot data will form part of the final trial data set.
We will analyse the effectiveness and cost-effectiveness of the intervention and explore the association between socioeconomic status and other participant characteristics (e.g. age, gender, etc) with WLM.

Planned Impact

The research on WLM support is in its infancy. To date there is very limited knowledge about effective and cost-effective means to support initially obese people after successful weight loss in preventing weight regain. While there is good evidence for the effectiveness of the drug orlistat, its costs and side effects limit widespread use. Even for people who respond well to orlistat, standard treatment involves long term behaviour change alongside medication, and evidence from behavioural WLM trials can contribute to improve treatment effects.
To date this evidence is limited and predominantly based on US trials. Very little is known about the best way to identify and reach individuals after successful weight loss through weight loss services or in communities or the best way of using current technology in delivering WLM interventions. Moreover, not a single WLM trial has been conducted in the UK seriously limiting the NHS in its capacity to manage obesity and thereby prevent morbidity and mortality. At this stage, the NHS and the public invest considerably in weight loss but the impact of this investment is limited as long term benefits will only accrue if weight loss is maintained and that rarely the case due to a lack of available evidence-based WLM interventions.
Beneficiaries include individuals and through them first and foremost the NHS and thus, the UK tax payer. Cost effective WLM interventions are a vital complement to existing services targeting weight loss and would benefit all NHS services directly and indirectly targeting obesity and coping with the consequences of obesity. These include general practice, public health and a range of services providing care people suffering from the consequences of obesity such as type 2 diabetes, heart disease, cancer, stroke, non-alcoholic fatty liver disease, Alzheimer's disease, etc. Moreover, many individuals make considerable personal investments to lose weight and the problem of the "Yo-Yo-effect" that is, people going cycles of weight loss and regain is well documented. A cost-effective evidence based WLM intervention would benefit the public by supporting proactive individuals in their efforts for maintenance of their weight loss.
The proposed intervention can be made available within two years after the completion of the project for widespread implementation and given the current lack of services for WLM at the moment, would make a considerable contribution to public health and prevention in the UK.

Publications

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Kwasnicka D (2015) Data-prompted interviews: Using individual ecological data to stimulate narratives and explore meanings. in Health psychology : official journal of the Division of Health Psychology, American Psychological Association

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Santos I (2017) Prevalence of personal weight control attempts in adults: a systematic review and meta-analysis. in Obesity reviews : an official journal of the International Association for the Study of Obesity

 
Guideline Title PHE Guide to Delivering and Commissioning Tier 2 Adult Weight Management Services
Description Changing Behaviour: Techniques for Tier 2 Adult Weight Management Services
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
Impact For the first time, guidance to commissioners commissioning adult weight management programme is explicitly addressing evidence based requirements for weight loss maintenance.
URL https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/620404/adult_weight_manage...
 
Description BHF Project Grants
Amount £142,943 (GBP)
Funding ID PG/17/68/33247 
Organisation British Heart Foundation (BHF) 
Sector Charity/Non Profit
Country United Kingdom
Start 12/2018 
 
Description Department of Health through the National Institute for Health Research School of Public Health Research Evaluation of the NHS Diabetes Prevention Programme Demonstrator phase in England
Amount £246,319 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 09/2015 
End 03/2017
 
Description Diabetes UK: DiRECT (Diabetes REmission Clinical Trial - very low energy diets for adults with type 2 diabetes in primary care)
Amount £2,500,000 (GBP)
Organisation Diabetes UK 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2013 
End 12/2018
 
Description Diabetes UK: Overcoming barriers to high quality care in diabetes through professional behaviour change (IDEA Trial)
Amount £381,506 (GBP)
Organisation Diabetes UK 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2012 
End 12/2015
 
Description DoH through NIHR: Evaluation of the NHS Diabetes Prevention Programme Demonstrator phase in England
Amount £246,319 (GBP)
Organisation National Institute for Health Research 
Department NIHR School for Public Health Research
Sector Academic/University
Country United Kingdom
Start 09/2015 
End 02/2017
 
Description EPSRC Next Stage Digital Economy Research Centre (DURC)
Amount £3,662,788 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Academic/University
Country United Kingdom
Start 01/2016 
End 12/2020
 
Description Horizon 2020: Evidence-based ICT tools for weight loss maintenance (The NoHoW programme)
Amount € 4,949,337 (EUR)
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 04/2015 
End 03/2020
 
Description NIHR School for Public Health Research Formative evaluation of the First Wave of the national implementation of the NHS Diabetes Prevention Programme in England
Amount £217,785 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 03/2016 
End 03/2017
 
Description Project grant application
Amount £515,389 (GBP)
Organisation Diabetes UK 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2018 
End 12/2019
 
Description Reducing alcohol consumption in obese men: Development and feasibility testing of a complex community based intervention
Amount £241,501 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 05/2014 
End 01/2016
 
Description Strategic research initiative - very low calorie diets
Amount £2,479,948 (GBP)
Funding ID 13/0004691 
Organisation Diabetes UK 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2014 
End 12/2019
 
Description Strategic research initiative - very low calorie diets
Amount £2,479,948 (GBP)
Funding ID 13/0004691 
Organisation Diabetes UK 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2014 
End 12/2019
 
Title Scales at home (mobile connected personal weight scales) 
Description We developed personal home scales connected to the mobile phone infrastructure ensuring maximal coverage of connectivity without the need for wireless networks. 
Type Of Material Technology assay or reagent 
Year Produced 2014 
Provided To Others? Yes  
Impact At this stage, there is a pending grant application for the EU Horizon2020 programme which involves the use of our scales led by Dr Amy O'Donnell. 
 
Description Collaboration with Susan Jebb's and Paul Aveyard's team at Oxford 
Organisation University of Oxford
Department Nuffield Department of Primary Care Health Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution Through this research we started collaborating with colleagues in Oxford and that has recently resulted in a BHF grant to conduct a major evidence synthesis project on weight loss maintenance.
Collaborator Contribution Advice and joint formulation of grant applications.
Impact not yet, grant has not started yet.
Start Year 2015
 
Description Invited lecture at the International Sport and Exercise Nutrition Conference 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact to be completed
Year(s) Of Engagement Activity 2013
 
Description Keynote 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact 13. Kongress für Gesundheitspsychologie (German Congress of Health Psychology)
Year(s) Of Engagement Activity 2017
 
Description Keynote Lecture at the International Society of Behvioral Nutrition and Physical Activity Annual Meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact to be completed
Year(s) Of Engagement Activity 2014
 
Description Keynote at the Conference of the Society of Social Medicine in Finland, Helsinki, 13.10. 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact I was invited to give this keynote in Finland to talk about our work on weight loss maintenance.
Year(s) Of Engagement Activity 2010,2017
 
Description NULevel Presentation (Cambridge, 2018, Association for the Study of Obesity East of England group meeting) Lessons from an RCT of a technology-mediated behavioural intervention to support weight loss maintenance 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Talk as part of a discussion session
Year(s) Of Engagement Activity 2018
 
Description Press release for BMJ paper reporting systematic review of Weight Loss Maintenance interventions 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Various national and international newspapers and media outlets picked up our press release and we had a fantastic international coverage of this important and often overlooked topic.

mostly emails from members of the public and health care professionals.
Year(s) Of Engagement Activity 2014
 
Description Talk at the UK Society of Behavioural Medicine conference 2013 in Oxford 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Talk presented the design and development of our NPRI intervention and initiated collaboration between research groups at Exeter, Cardiff and Birmingham working in weight loss maintenance

Initiated collaboration between research groups at Exeter, Cardiff and Birmingham working in weight loss maintenance
Year(s) Of Engagement Activity 2013
 
Description The National Prevention Research Initiative Lecture (invited by the MRC) at the UK Society of Behavioural Medicine Conference, 9 Dec 2015 Newcastle upon Tyne 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact This was a keynote address invited by the NPRI programme panel to present the work resulting from the NPRI grant.
Year(s) Of Engagement Activity 2015
 
Description Weight Loss Maintenance Symposium at the First UK Congress on Obesity in Birmingham 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact This was the first symposium at a national obesity conference raising the issue of weight loss maintenance and connecting active research groups across the country.

Resulted in an editorial for the British Journal of Health Psychology with Drs Greaves and Simpson
Year(s) Of Engagement Activity 2014