Draft 4: July 2004

Diabetes in Specialist Care: Obesity Management

(D.I.S.C.O) Project

Project Document

Jacqueline Anne Troughton asserts the right to be identified as the author of this work.

May 2004

Contents Page

1. General background2. Local needs3. Project definition4. Project scope5. Project organisation structure6. Project terms of reference and constraint7. Quality plan8. Audit Criteria9. Risk management10.Outline of plan (control plan)11.Exit Strategy

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Diabetes service development in a Secondary Care Trust

EXECUTIVE SUMMARY

The scene is set over the next ten years for a dramatic increase in the prevalence of diabetes. Leicestershire could face nearly 10, 000 new cases by 2010 attributable to weight alone.

Currently people with diabetes using the Secondary Care Diabetes service may be restricted in their choice of management options as there is limited resource and lack of infra structure to support those individuals who wish to engage in weight loss programmes

It is felt that there is a need to develop the existing diabetes service to encompass obesity/lifestyle management as an integral part of diabetic care to enable choice for people with diabetes.

An Advanced Diabetes Practitioner has been appointed for eleven hours a week to develop and manage the implementation of a diabetes specific strategy for the management of obesity in the Secondary Care Service, which complements the Leicestershire and Rutland Obesity Strategy.

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Diabetes service development in a Secondary Care Trust

1. General Background

1.1 Diabetes

Diabetes is a serious global health problem, predicted to present one of the largest medical challenges of the 21st century. It is a lifelong disease, which has a major impact on mortality and is a significant cause of severe morbidity and serious physical and emotional distress.

The prevalence of type 2 diabetes currently estimated at 4% of the world population is projected to increase by over 120% between 1994 and 2025 (from 235 million to 300 million). Although this burden is likely to fall disproportionately on developing countries with a 170% rise, industrialised countries may also face a 41% increase. The increase is partly due to epidemiological transition but other factors such as observed reduction in physical activity and a corresponding increase in obesity are likely to be implicated

Type 2 Diabetes currently accounts for 4.7% of the annual NHS budget, representing £2 billion a year (T2ARDIS 2000). The greatest part of these costs is related to the dealing with the complication of diabetes, including coronary heart disease, stroke, renal disease, diabetic foot problems and eye disease. It is estimated, for instance, that the average cost of treating a diabetic foot ulcer is £3,600 a year. Complications of diabetes can lead to premature death, blindness and amputations.

The UKPDS clearly indicated that intensive blood glucose control, compared with conventional diabetes treatment, can reduce the risk of micro vascular and macro vascular morbidity and mortality in people with type 2 diabetes. These benefits were seen despite an increase in body weight.

1.2 Obesity:

The World Health Organisation has defined obesity as a’ disease state in which excess fat has accumulated to an extent that health may be adversely affected’, and has categorised normal weight, overweight, obesity and severe obesity using the body mass index. (BMI, kg/m2). However BMI takes no account of the distribution of body fat. It is well recognised that it is obesity with an abdominal distribution (also termed central or visceral obesity) rather than gluteal fat accumulation, which is associated with insulin resistance, a very atherogenic lipid profile and other features of the metabolic syndrome.Diabetes UK recommends assessment using both BMI and waist circumference (WC).

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Highest Health Risk Associated with waist circumference:

Men greater than 102 cm (greater than 40in)Women greater than 88 cm (greater than 35in)Asian men greater than 90 cm (greater than 36in)Asian women greater than 80 cm (greater than 32 in)

Health risk associated with Body Mass Index (BMI):

BMI is weight (kg)Height (m)squared

BMIKg/m2

BMI Asianorigin

Obesity Class Health Risk

Underweight Less than 18.5 Less than 18.5Normal 18.5-24.9 18.5-22.9Overweight 25-29.9 23-24.9 increasedObese 30.0-34.9 25.0-29.9 1 high

35.0-39.9 30.0-34.9 11 Very highMorbid Greater than 40 Greater than35 111 Extremely high

The prevalence of obesity and overweight has increased rapidly over the past two decades in the developed world and it has been described by the World Health Organisation as ‘ a global epidemic’ ( WHO 1998). The prevention and management of obesity has been a national government policy concern for a number of years; the Chief Medical Officers Annual Report 2002 (Department of Health, 2003) highlighted obesity as ‘the health time bomb’ and recognised that obesity is a growing challenge for government as a whole.

Since 1980 the prevalence of obesity has nearly trebled in the UK and is continuing to increase. When combining the overweight and obese groups nearly two thirds of men and half of women were either overweight or obese in 2001 (Joint Health Surveys Unit 2002).

Being obese or overweight means a higher risk of suffering a range of serious chronic diseases, including type 2 diabetes, cardiovascular disease, hypertension and stroke, and certain forms of cancer. Analyses carried out for World Health Report 2002 found that approximately 58% of diabetes, 21% of ischaemic heart disease and 8-42% of certain cancers globally were attributable to a BMI above 21 kg/m.

Obesity and overweight is a considerable burden to England economically (National Audit Office 2001). In 1998, over 18 million days of sickness were attributable to obesity and the total cost of obesity was £2.6 billion for England.

More recently (2004), the report – “Storing up Problems: the medical case for a slimmer nation; recommends that ‘the prevention and management of overweight and obesity should be included in all NHS plans, policies and clinical care strategies. Appropriate training programmes for doctors, nurses and other health professionals should be established’

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1.3 Benefits of weight loss 

Weight loss in overweight and obese adults has been shown to have various health benefits. SIGN guidelines report the following benefits from a 10kg weight loss in people with an initial weight of 100kg and co-morbidities:

Mortality

Blood pressure

Diabetes

Lipids

>20% reduction in total mortality>30% reduction in diabetes-related deaths>40% reduction in obesity-related cancer deaths

Reduction in systolic and diastolic blood pressure by about 10mmHg

Reduction in fasting blood glucose by 50%

Reduction in total blood cholesterol by 10%Reduction in blood low density lipoproteins by 15%Reduction in blood triglyceride levels by 30%Increase of 8% in blood high-density lipoproteins.

For very obese people a 10kg loss in weight will not take them out of the “at riskCategory. However, this will still result in significant health gains for these individuals.

Much evidence exists that effective obesity treatment may delay or even prevent diabetes in the ‘at risk’ obese subjects (Finnish Prevention Programme, Diabetes Prevention Program, XENDOS study , SOS study), yet so far there has been little concerted effort nationally to manage this growing health problem.

1.4 Is obesity realistically treatable in those with type 2 diabetes?

Both peripheral insulin sensitivity and the ability of insulin to suppress hepatic blood glucose output are improved as weight is lost. The insulin response to a glucose load tends towards normalisation after weight reduction, whether it is elevated (as in people with IGT) or blunted (as in people with frank diabetes). Plasma free fatty acid and lipid oxidation are reduced after weight loss, leading to improved glucose storage and glucose uptake.

‘Obesity is arguably the greatest challenge in the management of diabetes, yet it is often conveniently dismissed as being untreatable, leading to almost total nihilism, or at best a referral to the dietitian’ (Wilding)Weight gain is a major obstacle to the successful treatment of people with both type 1 and type 2 diabetes, with weight gain being only second to hypoglycaemia as complication of treatment with insulin and sulphonylureas.

Many of the complications associated with diabetes, including dyslipidaemia, hypertension and stroke could be considered as much complications of the obesity as they are of the diabetes. One could argue that although we have modern pharmacology to treat these complications these ignore the mechanical, psychological and quality of life effects of obesity that is often the major concern of obese patients. Despite scepticism, there is a growing body of evidence that obesity is treatable in many patients with type2 diabetes, and that effective management of this problem can improve short tem outcome measures, such as HbA1c, hypertension and dyslipidaemia.

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In the largest published study of weight loss in overweight people with diabetes, intentional weight loss (from a mean of 100 kg down to 89 kg) was associated with a 25% reduction in total mortality and a 28% reduction in cardiovascular and diabetes mortality. The greatest reduction in mortality was associated with intentional weight loss of 9-13 kg, but lesser degrees of weight loss were seen to be beneficial

Achieving long-term weight loss can be notoriously difficult and there is no blue print strategy for success. The NHS Health Development Agency recently produced an evidence briefing summary for the management of obesity and overweight. Although the document is not specific to people with diabetes, the findings are relevant.The Evidence briefing document presents an overview of the findings and recommendations from a systematic review of selected systematic and other reviews and meta analyses published since 1996.

For treatment with diet, there is evidence to: Support the effectiveness of low calorie diets ( 1000-1500 kcals) Suggest clinically prescribed very low calorie diets (400-500 kcals per day) are more

effective for acute weight loss than low calorie diets. However there is conflicting evidence regarding long term effect.

Support the effectiveness of low fat and low energy diets combined with energy restriction, and low fat diets alone (where 30% or less total daily energy is derived from fat). However there is conflicting evidence regarding their relative effectiveness.

For treatment with Physical Activity, there is evidence that: Increased physical activity is effective in producing a modest weight loss. However diet

alone was more effective than exercise alone Physical activity alone, diet alone and physical activity and diet combined are effective

interventions

For behavioural and/ or cognitive therapy techniques, there is evidence that: A combination of behavioural techniques in conjunction with other weight loss

approaches is effective for the treatment of adult obesity over a one year period

Limited evidence of effectiveness supports: Extending the length of behavioural therapy Group behavioural therapy Correspondence courses Provision of structured meal plans and grocery lists Cue avoidance ( cognitive therapy) Rehearsal of ones thoughts and behaviours prior (cognitive rehearsal)

The Diabetes National Service Framework (2003), standard 3 makes recommendations about empowering people with diabetes that ‘All children, young people and adults with diabetes will receive a service which encourages partnership in decision-making, supports them in managing their diabetes and helps them to adopt and maintain a healthy lifestyleAchieving this standard will be reflected in an agreed and shared care plan in an appropriate format and language. Where appropriate, parents and carers should be fully engaged in this process

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2. Local Needs

Precise local figures of obesity in Leicestershire are unfortunately unknown, but Leicestershire is unlikely to be different to England’s average. In fact, due to large proportion of South Asian population the effect of obesity may be even exaggerated in urban areasAssuming that the expected prevalence of diabetes in obese subjects is 10% and 6% in overweight subjects, Leicestershire could face nearly 10, 000 new cases (or an additional 1% in prevalence) by the year 2010 attributable to weight alone.

2.1. Implications for Secondary Care

It is likely that a greater proportion of the increase in work -load due to diabetes will fall on primary care. However it is probable that more people with diabetes will access the system overweight or obese. In UHL, we do not currently have a clear strategy in place to deal with this expected problem. Within secondary care diabetes service, it appears that there is no systematic and standardised approach to the management of obesity within this patient group.

The obesity strategy for Leicestershire and Rutland (June 2003) does not appear to have a gold standard of treatment on which to audit. The only recommendations for Secondary Care are for ‘Secondary care to establish specialist weight management clinics for the morbidly obese and identify training needs for healthcare professionals and others’. It gives no specific recommendations for Diabetes Services.

The National Obesity Forum (NOF) 2003 gives us guidance on who we should be targeting with weight management/ lifestyle advice, but it is felt unlikely that the present service is set up to enable the achievement of these recommendations.

NOF 2003 Recommendations are that:

Treatment or advice should be offered to: Patients with a BMI> or equal to 30kgm2 Patients with a BMI > or equal to 28kgm2 with co morbidities Patients with any degree of overweight coinciding with diabetes, other risk factors or

serious disease. Patients who self refer where appropriate Parents of families with one or more obese or overweight member may need special

consideration and more intensive support Preventative advice should be offered all high risk individuals e.g. those with a family

history of obesity, smokers, and people with learning disabilities, low income groups

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2.2. Staffing Levels (taken from Diabetes Health Needs Assessment for Leicestershire 2003

Specialist Diabetes UK recommended level (WTE)

Diabetes UK recommended level (WTE)

Current level

Per 250k population

Leics(1min)

LRI (540 k) GH (360k)

GGH LRI LGH Across UHL

Consultant physicians with responsibility for diabetes

2.5 10 5.4 3.6 3 3 6

Diabetes Specialist Nurses

4 16 8.6 5.8 1.6 6.3 5.5 11.8

Dietitians 1.5 6 3.2 2.2 1.4 1.5 2.9

Podiatrists 2.5 10 5.4 3.6 1 0 1

In the recent Health Needs Assessment for people with diabetes in Leicester, Leicestershire and Rutland, April 2003, the dietetic service (LNDS) reported that there is an inequity of access to see a dietitian and inequity of dietetic resource across hospital sites. LNDS doesnot currently have enough staff to cover the increased workload of the diabetes service within the UHL

Secondary care may need to adopt new ways of working to cope with this epidemic, which may involve moving some work out to primary care, but in terms of offering lifestyle advice, dietitians may need to consider new ways of delivering care, and upskilling other members of the multi disciplinary team

Currently people with diabetes using the Secondary Care Diabetes service may be restricted in their choice of management options as there is limited resource and lack of infra structure to support those individuals who wish to engage in lifestyle changes, for example weight loss

It is proposed there is a need to develop the existing a diabetes service to encompass weight /obesity/lifestyle management as an integral part of diabetic care to enable choice for people with diabetes.

3. Project Definition

3.1 Project objectives

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Evaluation of current service provision re lifestyle management offered as part of service to people with diabetes to include HCP attitudinal survey. With reference to national standards. (Baseline)

Develop and implement a Care Pathway for a management of people with obesity and diabetes. To create a standardised approach to referral, screening and management of people with diabetes who are obese to incorporate existing guidelines & standards national guidelines, standards (i.e. NSFs, NICE) and best practice.

To develop and run lifestyle/weight management programmes (group sessions) for people with diabetes who have chosen this option.

Upskilling of all HCPs within the service re understanding of relevance of lifestyle /obesity in the management of diabetes to effect a change in clinical practice.

Evaluation of the impact of the above on the care and experience of the service users. (Clinical & QOL)

Evaluation if the project impact on HCPs (attitude/ job satisfaction)

Engage with Primary Care and Leicestershire Nutrition & Dietetic Service (LNDS) to inform re the project and work jointly to share “best practice” to identify how the project can inform development and implementation of Leics Obesity Strategy

3.2 Project approach

Provision of “advanced diabetes practitioner (J.Troughton)”resource for 11 hours per week to develop, implement and manage the D.I.S.C.O project over a 3-year period.

And more specifically

To conduct assessment of current service provision re lifestyle management offered as part of service to people with diabetes to include HCP attitudinal survey to obesity and its management. This will also include audit of what protocols /guidelines/educational resources currently available.

To develop protocols/guidelines standardising approach to referral, screening and management of people with diabetes who are overweight & obese. (To include pharmacotherapy)Referral & screening: -development of motivational assessment tool – to determine individual’s readiness to change.Management : to develop integrated care pathway which incorporates those already in existence (to include lifestyle & weight management.)

To act as resource to healthcare professionals within the Diabetes service. To develop resources and source materials to support project. To engage with HCPs within the diabetes service to up skill in understanding of

relevance of obesity in management to effect clinical practice. To provide people with diabetes the opportunity to access educational/lifestyle

programmes.All patients with BMI 28 (BMI 25+ indo-Asian) to be screened via diabetes educator using assessment tool to evaluate readiness for lifestyle change.

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Options available to be signposted to the individual (i.e. exercise on prescription) to include attending group sessions being piloted by diabetes service. Clinicians to discuss options with individual and agree care plan.

To organise and run weight management programmes (group sessions) for people with diabetes who have chosen this option: -

Initially group sessions to be run by J.Troughton with another HCP, as a pilot (subject to funding-supported by Chas Skinner –Psychologist Univ Southampton). Following evaluation of group’s pilot, it is envisaged that other HCPs will be trained to facilitate group sessions to increase capacity.

Approval will need to gain from management for HCP time to be available for training and delivery of group sessions.

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4. Project Scope

Job Title: Advanced Diabetes Practitioner

Base: Leics General / Univ. Hosp Leics

Reports to: Diabetes Service Manager

Accountable to: Head of Service Diabetes – Melanie Davies

Salary: H Grade

Hours: 11 hours per week.

4.1 Outline of Job Purpose

To develop and manage the implementation diabetes specific strategy for the management of obesity in the secondary care diabetes service, which compliments the Leics & Rutland Obesity strategy. This will take the form of a pilot project.

This post requires a high level of vision and experience of diabetes/dietetic practice, within secondary care. Evidence of higher-level learning.

4.2 Responsibilities

To produce a Project Plan detailing the planned milestones for the duration of the project.

To act as project manager for the project and produce regular updates / reports both to the Project Board and the stakeholders as required

To conduct assessment of current service provision To develop protocols/guidelines standardising approach to referral, screening and

management of people with diabetes who are overweight & obese. To act as resource to healthcare professionals within the Diabetes service. To develop resources and source materials to support project. To engage with HCPs within the diabetes service to up skill in understanding of

relevance of obesity in management to effect clinical practice. To provide people with diabetes the opportunity to access educational/lifestyle

programmes To organise and run lifestyle/weight management programmes (group sessions) for

people with diabetes who have chosen this option Engage with Primary Care and Leicestershire Nutrition & Dietetic Service (LNDS) to

inform re the project and work jointly to share “best practice” to identify how the project can inform development and implementation of Leics Obesity Strategy.

To access clinical supervision and support from the Dietetic service and the Diabetes service team

This list is by no means exhaustive.

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4.3 Time

3 years commencing 1st March 2004.

4.4 Support and Resource

Office /desk space to work PC /Laptop with intra & Internet email access, supplied with word, excel &

PowerPoint in order to manage project, audit data etc. Secretarial /admin support. (Hours?) Room to run group sessions Equipment to run group sessions: scales; support materials (leaflet, food diaries etc);

pedometers; waist tape measures. Research team support –re evaluation and writing up project. Establishment of Project Steering group. Project management support.

5. Project Organisational Structure

5.1 Project Board

Proposal as follows: -

Dr.M.Davies (Head of Service –Diabetes) Denise Hatton (Business services manager) H.Daly (Nurse Consultant –Diabetes) Dr S.Jackson (Consultant –Diabetes) Anita Khulphatea / Rosie Gorrard (DSN nurse managers) Sherry Waldron (Representative from Diabetes Dietician Service) LNDS representative on obesity strategy Janet Jarvis (Research) Service user?(co-pt)

The Project Board is accountable for the success of the project, and has responsibility and authority for the project within the remit of relevant organisations.

5.2 Review Meeting

Project review meetings will be arranged monthly The Project Board will be supplied with a regular progress update on the project

5.3.Project Management

Project Manager =J.Troughton

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Project management has been offered by RocheHealthcare management (Carl Needham)

The project manager’s prime responsibility is to ensure that the project produces the required outcomes, to the required standards of quality within the specified constraints.

5.4. Project viability

Adherence to quality assured standards Adherence to project plan Project fit to strategy Checks on expenditure and schedule

6. Project Terms of Reference and Constraints

6.1 General

The project board agree to the following:

Clear key milestones and objectives will be established and reviewed at agreed intervals

To ensure Caldicott Principles are strictly adhered to.

7. Quality Plan

Quality Systems in place -audit

Trust clinical governance systems in place

Clinical Governance leads maintain quality assurance in respective organisations reviewing project stage reports and ensuring audit processes operate at acceptable levels

8.0 Audit Criteria

To be agreed by the project board and to be guided by research staff

Hard measures: Changes in BMI / BP /HbA1cChanges in medication requirements

Soft measures: User experience. / QOLHCP confidence /attitude in managing obesity.

Further work to be completed on this based upon what group sessions programme looks like.

9. Risk management

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The Project Manager is responsible for ensuring that risks are identified, recorded and reviewed.

The Project Board is responsible for:

Notifying project manager of external risks i.e. financial constraints Making decisions from the project managers recommended actions Notifying all stake holders of any risks which may affect the projects ability to

meet its acceptance criteria Note further risk analysis recommended for following: Inadequate resource to manage functional day to day running of diabetes service

once project complete Exit Strategy

10. Outline of Plan (Control plan)

The project board will guide the timing of the project plan.

12.Exit Strategy:

To be completed

13.References

1. Fuller JH, Stevens LK, Wang SL. International variations in cardiovascular mortality associated with diabetes mellitus; The WHO multi national Study of Vascular disease in diabetes. Ann Med 1996; 28:310-322

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2. Zimmett P, Alberti KGMM, Shaw J. Global and societal implications of the diabetes epidemic. Nature 2001, 414, 782-7

3. Baghurst A, Hopkinson PK, Maslove L, CurrieCJ. The projected healthcare burden of Type 2 diabetes in the UK from 2000 to 2060. Diabetic Med 2002 Jul Suppl 4 1-5

4. Audit Commission. Testing times: A review of diabetes services in England and Wales. 2002. London, Audit Commission

5. T2ARDIS Steering committee. The economic impact of type 2 diabetes on the individual and their carer are far reaching. Abstract 968 Brighton BDA 2000

6. Gray A, Clarke P, Farmer A, Holman R on behalf of the UKPDS group. Implementing Intensive control of blood glucose concentration and blood pressure in type 2 diabetes in England: Cost analysis. BMJ 2002 325, 860-863

7. World Health Organisation. Obesity: Preventing and Managing the Global Epidemic. WHO technical report Series 894.World Health Organisation. Geneva 2000

8. Nutrition Subcommittee of the Diabetes Care Advisory Committee of Diabetes UK. The implementation of nutritional advice for people with diabetes. Diabetic Medicine 2001 20, 786-807

9. WHO/FAO Joint Expert Consultation into diet, nutrition and Prevention of chronic diseases. WHO Report series 916, March 2003

10. National Audit Office. Tackling Obesity in England. The Stationary Office 2001

11. Joint Health Surveys Unit on behalf of the Department of Health (2002). Health Survey for England 2001. London Stationary Office.

12. Report of the working party of the Royal College of Physicians, Royal College of Paediatrics and Child Health and the Faculty of Public Health Medicine  Storing up Problems: the medical case for a slimmer nation “ Feb 2004

13. Scottish Intercollegiate Guidelines Network (SIGN) Obesity in Scotland, Integrating Prevention with weight management. SIGN Report No 8, 1996, Edinburgh, Royal College of Physicians

14. Toumilhto J, Lindstrom J, Erriksson JG, et al. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Eng J Med 2001, 245,790-797

15. Diabetes Prevention Program Research group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Eng J Med 2002, 346, 393-403

16. Torgerson JS, Hauptman J, Boldrin MN et al. XENical in the prevention of diabetes in obese subjects (XENDOS) study. A randomised study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients. Diabetes Care 2004, 27 155-161

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18. Pinkney JH, Sjostrom L. Should surgeons treat diabetes in severely obese people? Lancet 2001, 357,1357-9

19. Wilding JPH.I s diabetes realistically treatable in type 2 diabetes? In: Difficult Diabetes, Eds G Gill, J Pickup and G Williams. Oxford: Blackwell Sciences, 2001

20. Williamson DF Thompson DJ Thun M, Flanders D, Pamuk E, Byers T. Intentional weight loss and mortality in overweight individuals with diabetes. Diabetes Care 2000 23, 1499-1504

21. Lean MEJ, Powrie JK, Anderson AS, Garthwaite PH. Obesity, weight loss and prognosis in type 2 diabetes. Diabetic Med 1989, 7 228-233

22. Erikkson KF, Lindgarde F. Prevention of type 2 (non insulin dependent) diabetes mellitus by diet and physical exercise: the 6 year Malmo feasibility study. Diabetologia 1991, 34 891-898

23. Wing RR, Koeske R, Epstein LH, Norwark MP, Gooding W, Becker D. Longterm effects of modest weight loss in type 2 diabetes. Arch Int Med 1987, 147, 1749-1753

24. Mulvihill C and Quigley R. The management of obesity and overweight: an analysis or reviews of diet, physical activity and behavioural approaches. London: HAD 2003

25. Department of Health: National Service Framework for Diabetes: Standards.2002.http://www,doh.gov.uk/nsf/diabetes

26. Health Needs Assessment for people with diabetes in Leicester, Leicestershire and Rutland. April 2003

27. National Obesity Forum Guidelineshttp:// www.national obesity forum

28. Must A et al. The disease burden Associated with Overweight and Obesity. JAMA 1999; 282:1523-9

29. Frost G, Dornhurst A, Moses R. (2003) Nutritional Management of Diabetes Mellitus. Wiley Publishers

30. Ha TKK, Lean MEJ. Technical Review. Recommendations for the nutritional management of people with diabetes. Eur J Clin Nutrition 1998 52 467-481

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