Randomised controlled trial of habit-based advice for weight control in general practice (The 10TT Trial)

Lead Research Organisation: University College London
Department Name: Infection and Population Health

Abstract

Most weight-loss programmes aim to encourage people to adopt healthy diet and activity habits. However, changes to lifestyle are known to be difficult to keep up, and tend to slip over time. Psychological research shows that repeating a behaviour in a consistent context can result in it becoming a habit (i.e. automatic). This research will test a treatment programme that uses theories of habit-formation to help people to maintain changes in their eating and activity behaviour over the longer term. The habit-formation approach has successfully helped overweight people to lose weight and keep it off in a small-scale trial with volunteers. This research will test whether it can help larger numbers of people recruited through GPs surgeries, and establish whether it could be cost-effective if it were adopted more widely within the NHS.

Technical Summary

Increases in obesity prevalence over recent decades have made weight control a key issue for public health. The cross-government strategy Healthy Weight, Healthy Lives identifies primary care as the ?first port of call? for advice about weight control, creating an urgent need for simple, effective interventions that can be delivered by the primary care team without specialist therapeutic skills.

A novel approach to health behaviour change draws on ?habit-theory?. Diet and activity behaviours are often loosely termed ?habits?, but few behaviour change interventions are based explicitly on the theory of habit-formation. The essential feature of habits is that they are automatic (i.e. require minimal deliberate effort). Habits are learned responses to environmental cues resulting from multiple repetitions in a consistent environmental context. They are more resistant to extinction than non-habitual behaviours because they don?t depend on deliberate self-control.

There has been growing interest in the role of habits in health behaviours, but existing research focuses largely on bio-behavioural mechanisms. In one of the first attempts to translate habit theory to practice, we used it to develop a simple weight-control programme. We took a set of simple behaviours known to be associated with weight control and presented them in leaflet format (TenTopTips) along with advice on how to make them habitual (repetition in consistent contexts, self-monitoring until automaticity developed). No further clinical contact was involved. Users involved in the development found it easy and effective. A trial in a volunteer population (n=104) showed that individuals randomised to receive the TenTopTips leaflet lost significantly more weight than the wait-list control group (-2.0kg vs -0.4kg in an intention-to-treat analysis; Lally et al, 2008). Weight loss was maintained over 32 weeks follow-up, with 54% (ITT=26%) achieving the 5% weight loss associated with health benefits. Weight loss was associated with increased automaticity of the behaviours, suggesting that development of habits underpinned the intervention?s effectiveness.

These results provide a strong basis for conducting a controlled trial of the effectiveness of the TenTopTips intervention in Primary Care and incorporating clinical outcomes and health-economic analyses. This application is for an individually-randomised, controlled trial of 520 obese adults across 10 General Practices comparing the TenTopTips leaflet with a usual-care control condition. The primary outcome is loss of body-fat, with secondary outcomes including clinical risk-factors, behaviour change and automaticity, and quality-of-life. A full cost-effectiveness analysis will be carried out and surveillance will continue for 24 months to establish longer-term maintenance.

Publications

10 25 50
 
Description GPRF 
Organisation Medical Research Council (MRC)
Department MRC General Practice Research Framework
Country United Kingdom 
Sector Academic/University 
PI Contribution The Trial Manager has worked with Senior Research Nurses from the GPRF to produce GP information sheets and letters, inviting them to take part in the study. She has also presented the study at a national GPRF meeting, to encourage nurses to take part.
Collaborator Contribution They have assisted us in the recruitment of GPs for our study, from which they will go on to recruit the patients to take part.
Impact GPs recruited to the study.
Start Year 2010
 
Description Weight Concern 
Organisation Weight Concern
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution The Trial manager worked closely with Weight Concern in developing and delivering the training to Nurse's involved in the study.
Collaborator Contribution A member of Weight Concern also sits on the Trial Steering Group.
Impact Training materials
Start Year 2010
 
Title 10TT 
Description Ten Top Tips (10TT) is a self-guided leaflet for weight management focusing on making simple diet and exercise behaviours habitual. It represents the first behaviour change intervention of which we are aware that has been explicitly based on habit-formation theory. The component behaviours in the 10TT leaflet reflect the consensus among researchers, clinicians and policy makers on healthy diet and lifestyle and were developed with input from these groups. This intervention was effective with respect to weight loss in a volunteer population, but has yet to be tested in primary care. The aim of the current trial is therefore to test the effectiveness of the 10TT intervention in primary care, incorporating clinical outcomes and health economic analyses. 
Type Therapeutic Intervention - Psychological/Behavioural
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2012
Development Status Under active development/distribution
Clinical Trial? Yes
Impact If proven to be effective when delivered through primary care, 10TT could make a highly cost-effective contribution to improvements in population health, with the potential to be delivered to all patients seeking weight management advice. 
URL http://www.cancerresearchuk.org/cancer-info/healthyliving/obesityandweight/tentoptips/
 
Title 10TT app 
Description we developed and piloted an app for android of the 10TT programme, this is not currently publically available 
Type Of Technology Webtool/Application 
Year Produced 2016 
Impact Research outputs and possible future developments to improve the app and make widely available 
 
Description 'If I knew then what I know now': Experience in developing and running trials, and lessons learnt. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact The talk was part of a session run by NPRI to raise awareness of the difficulties involved in developing and running trials, and issues that need to be taken into consideration when planning a study. The talk was received very positively and a number of researchers approached us for advice on how to deal with issues within their own work around recruitment, follow up, etc.

The activity promoted awareness of the 10 Top Tips Trial, and proved a positive networking opportunity.
Year(s) Of Engagement Activity 2012
 
Description Blog post 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Forming habits and improving self-regulation skills help people to lose weight on 'Health Chatter' by the Department of Behavioural Science and health
Year(s) Of Engagement Activity 2017
URL http://blogs.ucl.ac.uk/bsh/2017/10/16/forming-habits-and-improving-self-regulatory-skills-help-peopl...
 
Description Blog post- CRUK Science Blog 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Blog post on habits as part of CRUK's new year's resolutions Science Blog series
Year(s) Of Engagement Activity 2017
URL http://scienceblog.cancerresearchuk.org/2017/01/01/science-can-help-your-new-years-resolutions-stick...
 
Description Delivering behaviour change advice to modify cancer risk by Dr Rebecca Beeken 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Nutrition Society's Nutrition and Cancer Networking Meeting, Sheffield
Year(s) Of Engagement Activity 2019
 
Description Examining the evidence of successful interventions based on habit theory By Dr Rebecca Beeken 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Warwick Behavioural Science Summit, Warwick
Year(s) Of Engagement Activity 2019
 
Description Featured in a talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Featured in a talk by Dr Rebecca Beeken- Promoting cancer prevention through a habit-based intervention: effects on self-regulatory skills, automaticity and weight loss. World Cancer Congress, Paris, France: Nov, 2016
Year(s) Of Engagement Activity 2016
 
Description Featured in a talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Featured in a talk by Dr Laura McGowan at the BDA Specialist obesity group annual Study event: Obesity- thoughts, feelings and behaviours, Birmingham, 29th-30th November 2017
Year(s) Of Engagement Activity 2017
 
Description Featured in a talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Featured in a talk by Dr Baptiste Leurent- Cost-effectiveness analysis with informative missing data. Economic evaluation seminar, York, UK: April, 2016
Year(s) Of Engagement Activity 2016
 
Description Featured in a talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Featured in a talk given by Dr Rebecca Beeken- Behavioural Treatment for Obesity. Institute of Human Nutrition, University of Guadalajara. Guadalajara, Mexico: July, 2017
Year(s) Of Engagement Activity 2017
 
Description Featured in a talk 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Featured in this presentation by Dr Rebecca Beeken- Inspiring behavioural change. Obesity- Tipping Back the Scales conference, Manchester, UK: April, 2017
Year(s) Of Engagement Activity 2017
 
Description GPRF meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact The presentation was given to 15 General Practice nurses, followed by a question and answer session. This sparked their interest in the study, and in their Practices taking part.

Due to significant interest from outside of London, the recruitment of practices was extended to the rest of England.
Year(s) Of Engagement Activity 2010
 
Description Invited talk - The 10 Top Tips Study. Key Advances in Clinical Trials- International Clinical Trials Day. London, UK: May, 2017. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact Talk by Dr Rebecca Beeken- The 10 Top Tips Study. Key Advances in Clinical Trials- International Clinical Trials Day. London, UK: May, 2017.
Year(s) Of Engagement Activity 2017
 
Description Invited talk at the national BDA Live conference (British Dietetic Association). Title- Behavioural research and obesity: harnessing habits to improve outcomes 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact This talk was by Helen Croker and was well attended and resulted in many questions being asked and interest in the programme. I was contacted afterwards by several people who wanted to know more about the intervention.
Year(s) Of Engagement Activity 2018
URL http://www.bda.uk.com/events/bdalive/live_2018/obesity
 
Description PRIMENT CTU Research Proposal Seminar 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact 30 academics attended a seminar in which an update of the trial was given including progress of the trial and difficulties faced .

Suggestions were made for optimising follow-up at the later time points of the trial, A request was made for the protocol from a senior academic within another department at UCL.
Year(s) Of Engagement Activity 2012
 
Description PRIMENT CTU Statistics meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact We were invited to present the trial to a group of statisticians and triallists for input on the design and planned analyses.

Helpful suggestions for the final data analysis plan were made.
Year(s) Of Engagement Activity 2011
 
Description Preliminary results from the 10TT trial (UKSBM, Oxford) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Academic peers attended a presentation of the preliminary results of the 10TT at a national conference, which sparked questions and discussion afterwards.

Several requests for the publication of these results have been made and we were invited to take part in a symposium at this years conference.
Year(s) Of Engagement Activity 2013
URL http://www.uksbm.org.uk/wp-content/uploads/2014/07/Parallel-session-D_Beeken.pdf
 
Description Supporting individuals to change their dietary behaviours by Dr Rebecca Beeken 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Undergraduate students
Results and Impact Presentation at Alpro Student Symposium, University of Leeds, UK
Year(s) Of Engagement Activity 2019
 
Description Talk- Results from the 10 Top Tips (10TT) Trial: A randomised controlled trial of habit-based advice for weight control in general practice. Bournemouth University, Psychology Research Seminar Series, Bournemouth, UK: Nov 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Postgraduate students
Results and Impact Talk by Dr Rebecca Beeken- Results from the 10 Top Tips (10TT) Trial: A randomised controlled trial of habit-based advice for weight control in general practice. Bournemouth University, Psychology Research Seminar Series, Bournemouth, UK: Nov 2016
Year(s) Of Engagement Activity 2016
 
Description Working with primary care nurses on the 10 Top Tips Trial 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact This activity was designed to encourage participation of primary care nurses in research; illustrating the benefits through the 10 Top Tips Trial. Feedback from the event was extremely positive, and a number of nurses got in touch to say they would be keen to disseminate and/or get involved in similar research projects in the future.

The activity promoted the engagement of primary care nurses in research and increased awareness of the 10 Top Tips trial and intervention.
Year(s) Of Engagement Activity 2013
URL http://. http://www.noclor.nhs.uk/news-events/event/research-event-practice-nurses-25th-september-2...