Background

The National Institute for Health and Clinical Excellence (NICE) has been asked by the Department of Health (DH) to develop guidance on managing overweight and obesity in children and young people through lifestyle weight management services.

In 2008, an estimated 314 to 375 weight management programmes for children were operating in England (Aicken et al. 2008). Some were local schemes, others were available on a regional or national basis – such as those listed in the DH’s ‘Child weight management programme and training providers framework’ (Cross Government Obesity Unit 2009). In addition, some adult weight management programmes may accept young people. Local commissioners need to be able to determine which programmes are effective and provide good value for money.

New evidence may support the development of guidance on how to commission lifestyle weight management services. This might include, for example, whether a minimum number of sessions are required to ensure cost effectiveness, or the best ways to provide ongoing support.

This guidance will provide recommendations for good practice, based on the best available evidence of effectiveness and cost effectiveness. It is aimed at commissioners, health professionals and providers of weight management services. It will also be of interest to managers in local authorities, schools and early years' settings, as well as to young people, their parents, carers and families.

The scope of the guidance describes what it will cover. See  Overweight and obese children and young people - lifestyle weight management services: final scope

Call for evidence 

While NICE will search the published literature for  evidence of effectiveness and cost effectiveness, and the views of those delivering and participating in weight management services,  we are aware that some evidence relevant to this topic may  be unpublished and as a result may not be identified by our searches.     

In particular we are aware that there may be:

• data from local, regional or national  weight management organisations which are unpublished because they are commercially sensitive
• data from evaluations and surveys  of local weight management programmes which may only be available locally through, for example, surveys carried out to inform  local planning processes, or monitoring and performance reports.   

We are also interested in relevant research which may be in press or in progress, or published research that might not be identified through NICE search processes.

Key questions to be addressed 

Overarching questions:

• How effective and cost effective are lifestyle weight management programmes in helping overweight or obese children and young people to achieve and maintain a healthy weight?   
• What are the essential components of an effective and cost-effective weight management programme for overweight and obese children and young people? 

Subsidiary questions:       

• How does effectiveness and cost effectiveness vary for different population groups? (Examples may include children and young people from different black and minority ethnic groups, from low-income groups, of different ages or genders, or with special needs.)
• What are the most effective and cost effective ways of addressing and sustaining behavioural change among overweight and obese children and young people using community-based weight management programmes?
• How does the inclusion of parents, carers and the wider family impact on the effectiveness of community-based weight management programmes for children and young people?
• What barriers and facilitators affect the delivery of effective weight management programmes for children and young people and how do they vary for different population groups?
• What are the views, perceptions and beliefs of the children, young people and their families who use weight management services?
• What are the views, perceptions and beliefs of the staff responsible for commissioning and delivering weight management services to children and young people?
• How can more overweight and obese children and young people be encouraged to join, and adhere to, lifestyle weight management programmes?

Types of evidence

NICE will be conducting two reviews and economic modelling to address the above key questions. We will be basing the reviews on data published from 2000 onwards. The reviews will focus on:

• The effectiveness and cost effectiveness of weight management programmes, which take a lifestyle approach[1] to helping overweight or obese children and young people achieve and maintain a healthy weight.
• The barriers and facilitators to implementing lifestyle weight management programmes including the views and perspectives of those delivering them and participating in them to include: children and young people, their parents and carers and the providers of lifestyle weight management programmes

NICE is interested in a range of evidence types which may help to inform these two reviews and the economic modelling. This includes data from:   

• Experimental  trials of the effectiveness or cost effectiveness of relevant interventions  including randomized and non-randomized trials, or before and after studies,
• Observational studies of relevant interventions for example,  case control or cohort studies,
• Qualitative survey and other observational studies of barriers and facilitators to delivering such interventions or the views, perceptions and beliefs of those using and delivering such services. This includes surveys, interviews, reports of focus groups, and process and outcome evaluations of local projects and interventions
• Analyses of cost effectiveness, cost benefit, cost consequences, cost utility, return on investment,  from an NHS or wider perspective
• Translational studies or data ’ i.e. studies which assess or data which shows the feasibility of rolling out programmes developed in an experimental context to an operational level in the community.  We are particularly interested in any impact this may have on effectiveness, cost effectiveness, acceptability and feasibility.     
• We are particularly interested in anonymised individual data (in order to link changes in weight, body mass index (BMI) or waist circumference adjusted for age and gender with the characteristics of the programme and of the young person.)We will ensure that the anonymity of the data is respected. For further details please  see Annex 1
• With financial data, we are interested in the cost to young people and their families of taking part in a weight management programme, as well as the costs to the local authority or the NHS, for example discounts by volume and for longer contracts. We are unlikely to be interested in the profits or losses to a commercial company.
• We are interested in measuring the cost effectiveness of a weight management programme from the viewpoint of those paying for it. The cost effectiveness analysis could also be carried out for subgroups (such as by gender, age, ethnicity or socioeconomic status).
• We are particularly interested in evidence that may help to better promote equality of opportunity relating to age, disability, gender, gender identity, ethnicity, religion and belief sexual orientation or socio-economic status. 

The following outcome measures are of interest: 

• Changes in weight, body mass index (BMI) or waist circumference adjusted for age and gender (for example, BMI or waist circumference z [standard deviation] scores or BMI centiles).   
• Maintenance of a healthy weight or BMI in the short, medium and long term.
• Intermediate measures such as diet or physical activity outcomes.
• Validated measures of mental wellbeing, for example:
• Emotional wellbeing (including happiness, confidence and self-esteem)
• Psychological wellbeing (including autonomy, problem-solving, resilience and attentiveness)
• Social wellbeing (relationships with others, bullying or social isolation).
• Satisfaction with service, including variations according to family circumstances, attendance and adherence rates, programme duration, completion and drop-out rates, follow-up of participants, sustainability of weight changes.

Submitting evidence

Relevant information can be submitted using the - stakeholder response form (published material) and stakeholder response form (unpublished material).

Due to copyright restrictions please only forward the details of references for papers published in peer reviewed or other press. Please note that we are no longer able to accept paper or electronic versions of evidence if it is published in the peer reviewed or other press. 

 Please note that the following material is not eligible for consideration:

• Promotional material
• Unsubstantiated or non-evidence-based assertions of effectiveness 
• Opinion/discussion pieces
• Forms with electronic attachments of published material (e.g. journal articles), or hard copies of published material. For copyright reasons, we cannot accept these copies. However, if you give us the full citation, we will obtain our own copy. Please include author/s, title, date, journal or publication details including volume and issue number and page numbers. We are able to accept attachments of unpublished reports, local reports / documents.

Unpublished material

If you are aware of trials/ongoing research relevant to our questions which are in progress please could you help us to identify that information by providing relevant information such as a link to a registered trial with the Cochrane Central Register of Controlled Trials (Clinical Trials).

http://mrw.interscience.wiley.com/cochrane/cochrane_clcentral_articles_fs.html

‘Academic in confidence’ or ‘commercial in confidence’ information

If you wish to submit relevant academic in confidence material i.e. written but not yet published, commercially sensitive information, unpublished information or research, please can you highlight which sections are confidential by using a highlighter pen or the highlighter function in ‘Word’. Please see Annex 1 and refer to section 4.4 of the Process Manual for further information on submissions of confidential material.

We would be grateful if you could send any relevant evidence by 5.00pm on 15th June 2012.

Please ensure that permission from the copyright holder has been obtained prior to sending us any paper or electronic copies. 

Paper copies can be sent to:

Rukshana Begum
Project coordinator,
Centre for Public Health Excellence
National Institute for Health and Clinical Excellence
71, High Holborn
London WC1V 6NA

We look forward to receiving your information and thank you in advance for your help.

References

Aicken C, Arai L, Roberts H (2008) Schemes to promote healthy weight among obese and overweight children in England. Report. London: EPPI Centre Social Science Research Unit

Cross Government Obesity Unit (2009) Healthy weight, healthy lives: child weight management programme and training providers network. London. Department of Health 

Annex 1

The use of ‘commercial in confidence’ and ‘academic in confidence’ data in the development of public health guidance: statement of principle

1. NICE is under obligations of transparency and fairness to all stakeholders,

among others, in the development of its guidance

2. The rights of the owners of the data provided to NICE must be respected.

Definitions

3. Commercial in confidence information is information provided in confidence relating to the commercial interests of the owner of the information.

4. Academic in confidence information is information provided in confidence in circumstances where disclosure could prejudice future publication of the information in a scientific publication. It would be expected that any information marked as academic in confidence is going to be published at some stage and that a timeline for publication can be given.

Submission of data

6. The amount of information submitted on an ‘in confidence’ basis should be kept to a minimum. The whole submission should not be marked as confidential. It is likely to be unacceptable to mark complete sections as confidential.

7. Only information that is genuinely confidential, such as actual numbers, should be marked as in confidence. NICE will only treat information in confidence if the material is in fact either ‘commercial in confidence’ or ‘academic in confidence’.

8. When marking data as confidential, organisations should indicate if this status will apply at the time NICE anticipates publication/presentation of the data. The last opportunity for organisations to review the confidential status of information is during the consultation on the draft guidance and its supporting evidence.

9. For all unpublished data submitted as ‘academic or commercial in confidence’ the minimum that should be made available for release is that which normally would be included in a CONSORT (or PRISMA) compliant abstract (http://www.consort-statement.org/?o=1011) and be suitable for public disclosure. An equivalent approach is required for all data and studies which underpin and are included in economic analyses and models, and for the economic model included in the submission if that is marked ‘academic or commercial in confidence’.

Presentation of data at PHAC or PDG meetings

10. Data that contributes to evidence of effectiveness and cost effectiveness can be presented to a PDG meeting or to a PHAC meeting provided the information is factual, accurate and not misleading.

11. ‘Academic in confidence’ information may be presented during the PDG and PHAC meetings, even if the meetings are conducted in public. However, the data owner retains the right to make a final decision in relation to the release of confidential information into the public domain

12. The data owner retains the responsibility for the release of ‘commercial in confidence’ data into the public domain. With the exception of presentation of data at PDG or PHAC meetings, the data owner retains the right to make a final decision in relation to the release of confidential information into the public domain.

Publication of data

13. In circumstances where NICE wishes to publish data regarded by the data owner as academic or commercial in confidence, both NICE and the data owner will negotiate in good faith to seek to find a mutually acceptable solution, recognising the need for NICE to support its recommendations with evidence and the data owner’s right to publication. However the data owner retains the right to make a final decision in relation to the release of confidential information into the public domain.

Economic models

14. NICE will normally disclose in full economic models provided by manufacturers/sponsors to NICE as part of a submission of evidence, together with the data on which such models are based. Exceptionally, data within a model can be treated as confidential if they contain or make practical the reverse engineering of confidential data inputs which are credibly specified as confidential by the organisation or company.

15. Model structures will not be accepted as confidential information, and by submitting a model the manufacturers/sponsor will be taken to have agreed that the model structure may be put into the public domain.

Disclosure of confidential data

16. NICE is challenged that confidential information it has received should be released in the interests of fairness, during the guidance development process or otherwise, data owners must on request promptly reconsider whether it is in fact necessary to maintain confidentiality.

17. NICE does not intend to make repeated requests for a prima facie tenable claim of confidentiality to be abandoned or modified, and it will accept the data owner’s judgement in that regard.

18. NICE cannot ‘second guess’ the motives of a data owner. If a data owner would not agree to the specific request for disclosure made, but would agree to some more limited disclosure (for example to a “confidentiality club”) then it is asked itself to suggest the disclosure it would find acceptable, rather than wait for NICE to propose the specific formula it may have in mind and discuss and agree a potential solution with NICE.

19. If disclosure is not possible the data owner must be prepared to assert  publicly that the information is considered to be confidential, and must submit evidence giving the justification for maintaining confidentiality in defence of NICE's maintenance of that confidentiality. In the absence of any such assertion and evidence, NICE shall be entitled to conclude that the information is no longer confidential.