Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults ENDORSED 18 SEPTEMBER 2003 © Commonwealth of Australia 2003 Paper-based publications This work is copyright Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth available from the Department of Communications, Information Technology and the Arts Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Intellectual Property Branch, Department of Communications, Information Technology and the Arts, GPO Box 2154, Canberra ACT 2601 or posted at http://www.dcita.gov.au/cca © Commonwealth of Australia 2003 Electronic documents This work is copyright You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, non-commercial use or use within your organisation Apart from any use as permitted under the Copyright Act 1968, all other rights are reserved Requests for further authorisation should be directed to the Commonwealth Copyright Administration, Intellectual Property Branch, Department of Communications, Information Technology and the Arts, GPO Box 2154, CanberraACT 2601, or posted at http://www.dcita.gov.au/cca ISBN Print: 864961 90 ISBN Online: 864961 96 Disclaimer This document is a general guide to appropriate practice, to be followed only subject to the clinician’s judgement in each individual case The guidelines are designed to provide information to assist decision-making and are based on the best information available at the date of compilation It is planned to review this Guideline in 2006 For further information regarding the status of this document, please refer to the NHMRC web address: http://www.nhmrc.gov.au For copies of this document contact: Phone: 1800 020 103 extension 8654 (toll free number) Email: phd.publications@health.gov.au Website: www.obesityguidelines.gov.au CONTENTS CONTENTS Preface vii Summary ix Evidence-based statements and recommendations xv Setting the scene 1.1 The obesity epidemic 1.2 The health burden 1.3 The financial burden 1.4 The benefits of weight loss 1.5 Possible detrimental effects of weight loss 1.6 Normal regulation of body weight 1.7 Abnormal regulation of body weight and the aetiology of obesity 1.8 At-risk groups 1.9 Obesity and eating disorders 1 7 8 10 Assessment 2.1 How is energy balance disturbed? 2.2 Why is energy balance disturbed? 2.3 Other considerations 21 21 22 31 Measuring overweight and obesity 3.1 'Gold standard' measures 3.2 Anthropometric measures 43 43 44 Treatment: general 4.1 A global approach to treatment and prevention 4.2 A treatment model 4.3 Treatment expectations 4.4 Treatment goals 4.5 Treatment duration 4.6 Treatment providers 4.7 Treatment emphasis 4.8 Selection of patients for treatment 4.9 The quality of obesity treatment studies 53 53 54 55 56 58 58 59 60 60 11 12 Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults iii CONTENTS Treatment: energy intake 5.1 Existing evidence of the effectiveness of diet therapy 5.2 Recent evidence on dietary therapy 5.3 Types of dietary approaches 5.4 Summary 5.5 Gaps in knowledge Treatment: physical activity 6.1 Secular changes in obesity and physical activity 6.2 Recent findings on physical activity 6.3 Summary 6.4 Gaps in knowledge 91 92 94 109 109 Treatment: behavioural therapy 7.1 Approaches to behavioural therapy 7.2 Behavioural treatment outcomes 7.3 Behavioural-drug combination therapy 7.4 Other psychological factors 7.5 Gaps in knowledge 119 119 121 129 129 131 Treatment: pharmacotherapy 8.1 Who should be treated with pharmacotherapy? 8.2 Pharmacotherapy treatment options 8.3 Drugs that inhibit nutrient absorption 8.4 Combined drug therapy 8.5 Potential new compounds 8.6 The ability of drugs to sustain weight loss 8.7 Cost-effectiveness of weight-loss drugs 8.8 Summary 8.9 Gaps in knowledge 137 139 139 145 148 148 149 150 150 151 Treatment: surgery 9.1 Who should be treated with surgery? 9.2 The effectiveness of bariatric surgery 9.3 Types of procedures 9.4 Benefits of surgical intervention 9.5 Risks of surgical intervention 9.6 Summary 9.7 Gaps in knowledge 157 157 158 158 168 169 170 170 10 Weight-loss supplements and alternative treatments 10.1 Weight-loss supplements 10.2 Commercial weight-loss programs 10.3 Gaps in knowledge 177 177 188 188 iv Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults 65 66 67 67 80 80 CONTENTS Appendix A The guideline-development methodology 197 Appendix B Diet therapy evidence (1997-2001) 206 Appendix C Physical activity evidence (1996-2001) 220 Appendix D Behavioural therapy evidence 228 Appendix E Sibutramine therapy evidence 234 Appendix F Orlistat therapy evidence 238 Appendix G Surgical treatment evidence 246 Appendix H Sources for appendixes 258 Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults v PREFACE P R E FAC E In recent decades the number of Australians who are overweight or obese has continued to increase: in 1999-2000 an estimated 67 per cent of adult males and 52 per cent of adult females were classified as overweight or obese In 1992-93, it was estimated that obesity was costing Australia $840 million a year, of which about 63 per cent was being directly borne by the health care system In 1997 the National Health and Medical Research Council’s Expert Panel on Prevention of Obesity and Overweight prepared Acting on Australia’s Weight: a strategic plan for the prevention of overweight and obesity The primary outcomes of that plan were the goals to ‘prevent further weight gain in adults and eventually reduce the proportion of the adult population that is overweight or obese; and to ensure healthy growth of children’ Undoubtedly, most of the work required to tackle overweight and obesity in Australia will take the form of population-wide strategies seeking to modify the ‘obesogenic’ modern social environment However, during the development of Acting on Australia’s Weight and the subsequent strategy, the need for clinical practice guidelines for the management of overweight and obesity in Australian adults and children became apparent So, in 2000, in collaboration with the Population Health Division of the Commonwealth Department of Health and Ageing, the NHMRC initiated the development of the guidelines In working on the project, and having determined that separate guidelines were required for adults and for children and adolescents, the NHMRC researched practices for managing overweight and obesity and ensured that the practices identified were multi-faceted—for example, strategies that span physical activity, diet and self-esteem These guidelines for adults are the result of a comprehensive assessment of the current scientific evidence They provide detailed evidence-based guidance for assessing and managing overweight and obesity in Australia They also highlight important health concerns associated with overweight and obesity and, through the provision of clinical practice information for at-risk groups, aim to improve health outcomes for people with conditions such as diabetes, cardiovascular disease and some cancers The evidence has been reviewed in detail up to January 2002 After review of the document by stakeholders, only key additional references to March 2003 have been added, in order to expedite the process of publication The guidelines focus primarily on the majority population in Australia It should be recognised that the problem among specific groups, and Aboriginal and Torres Strait Islander peoples in particular, has distinct characteristics that are currently less well understood and need urgent, detailed examination Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults vii PREFACE The guidelines are designed for use by general practitioners and allied health professionals when providing advice to patients in the clinical setting Information for consumers is also being developed It is stressed that the guidelines are for clinical practice They not represent a comprehensive population-based approach to overweight and obesity in adults: that was the task of Acting on Australia’s Weight, and it will be addressed again in future NHMRC publications It is recommended that these guidelines be updated and revised by 2006 viii Clinical Practice Guidelines for Management of Overweight and Obesity in Adults SUMMARY S U M M A RY B AC K G RO U N D Overweight and obesity are in epidemic proportions throughout Australia: it is estimated that 67 per cent of adult males and 52 per cent of adult females were overweight or obese in 1999-2000 The figures are even higher for some ethnic and age groups This epidemic of overweight and obesity is part of a worldwide trend, and it is contributing to increasing levels of non-communicable metabolic and mechanically induced disorders such as diabetes, cardiovascular disease, joint problems, obstructive sleep apnoea, and some cancers While the causes of the problem are diverse, it is the interaction between humans’ varying levels of genetic, cultural and socio-economic predisposition to weight gain, and an increasingly ‘obesogenic’ modern environment, that is propelling the epidemic and explains the inter-individual differences in response ASSESSMENT As well as the assessment of weight related co-morbidities (such as dislipidaemia, hypertension and hyperglycaemia), clinical assessment of overweight and obesity requires two other important aspects: examining energy intake and physical activity levels to assess how energy imbalance has occurred; and considering the nature of the environment, personal reasons and other factors to understand why it has occurred Clinicians should take into account a person’s weight history, background, family, work and social environments, the presence of medical co-morbidities, motivation and readiness to change, and the costs and benefits of weight loss before prescribing any treatment MEASUREMENT There are no perfect measures of overweight and obesity in the clinical situation The most useful absolute indicator of risk and relative change is a combination of anthropometric measures such as body mass index (BMI) or weight and waist circumference Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults ix SUMMARY T R E AT M E N T : G E N E R A L Obesity is a chronic problem There is no single, effective treatment for all overweight and obese people, and the problem tends to recur after weight loss Some treatments (such as surgery) may be more effective than others in terms of total weight loss in certain circumstances People’s expectations of weight loss often exceed the capabilities of available programs, making successful treatment more difficult However, weight loss has a strongly beneficial effect on the co-morbidities of obesity, with the degree of benefit usually related to the amount of weight loss Even a modest loss of to 10 per cent of starting weight can result in significant health benefits All successful treatments involve some form of lifestyle change affecting energy intake (food) or energy expenditure (physical activity), or both Among the aids to treatment are behaviour modification, some medications, low-energy or very low energy diets, and surgery Treatment can be considered in a step-wise fashion, as shown in the following figure The bottom steps suggest that that the clinical role must be supported by public health measures for an integrated approach to the problem A stepped model for clinical management of overweight and obesity Target population Intervention Obese or overweight with risk factors (BMI >30 or BMI >27 with risk factors) Medical surgical Rx Overweight/obese (with disordered eating patterns or cognitions) Overweight/obese General population Behaviour modification Individual education and skills training Population education and awareness raising Source: Reproduced with permission—reference 10, Chapter x Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults SUMMARY T R E AT M E N T : E N E R G Y I N TA K E The effectiveness of any diet depends on the energy imbalance produced by a reduction in energy intake in relation to energy expenditure This can be done in many ways, but some methods are more effective and have less deleterious effects than others A variety of diets involving a reduction in energy intake lead to short-term weight loss The current evidence base indicates that low-fat ad libitum eating plans, resulting in a daily energy reduction of to megajoules a day, in combination with increased physical activity, appear to be the most effective for long-term weight loss It is possible that the primary mechanism through which low-fat diets exert their influence is reduction of energy density Other forms of low-energy density diets are being researched and may prove equally effective However, the evidence is not currently available Low-energy (that is, to megajoules a day) and very low energy (1.7 to 3.3 megajoules a day) formula diets can lead to significant weight loss in the short term in motivated people under strict supervision In the long term (say, five years), however, they result in no greater weight losses than an ad libitum low-fat eating plan T R E AT M E N T : E N E R G Y E X P E N D I T U R E It is more difficult to cause an energy imbalance leading to short-term weight loss through physical activity than it is through dietary restriction A regular pattern of physical activity is, however, one of the key factors involved in long-term maintenance of weight loss Lifestyle-based changes that increase the volume of physical activity (where volume = frequency x duration x time) significantly above the baseline level are likely to be best for long-term weight loss Regular, weight-bearing exercise (for example, walking) that the person enjoys is most effective for weight loss A non-weight bearing form of activity (such as swimming, walking in water or cycling) may, however, be best for very immobile, obese patients until their level of fitness increases and weight-bearing activities can be more easily carried out T R E AT M E N T : B E H AV I O U R A L T R E AT M E N T S Behavioural therapy can increase the effectiveness of other weight-loss treatments, and the duration of the therapy influences the ability to maintain the weight loss No single behavioural therapy strategy appears to be superior for long-term weight loss Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults xi APPENDIX G – SURGICAL TREATMENT EVIDENCE Follow-up Weight-loss difference (EBW=excess body weight) Mortality/morbidity/complications 98% follow-up Maximum follow-up was 12.9y % loss of EBW was 74% at 2y (n = 1284) and sustained through to 12y (78%, n=58), with no differences between morbidly obese and super-obese patients In a subgroup of 53 patients, body weight fell from 127.6kg to 83kg at 1y and 79.4kg at 3y Serum glucose and cholesterol normalised In the first post-operative months early satiety may be association with epigastric pain and vomiting These symptoms regress with time For the rest of their lives, patients can absorb only minimal fat, little starch, and sufficient protein The vasomotor phenomena characterising the dumping syndrome are absent after BPD At full resumption of food intake, BPD subjects have 2-4 daily bowel movements of soft stools All have foul-smelling stools, and most have flatulence These problems tend to decrease with time Operative mortality was 0.4%, general complications were 0.4% and surgical complications were 1.2% between 1991 and 1997 (these values are half those reported between 1984 and 1991) Specific late complications include anaemia (40% but 60% of patients observed BMI at 1y was 35.1 at each follow-up BMI 4y it was 31.5 No intra-operative or complication-related mortality Post-operative mortality was 0.55% for causes not specifically realted to LASGB implantation The laparotomic conversion rate was 1.7% Complications occurred in 143 patients (11.3%) Pouch dilatation was diagnosed in 65 patients (5.2%) and 28 of these underwent reoperation Band erosion occurred in 1.9% Port or connecting tube-port complications occurred in 4.2% Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults 255 APPENDIX G – SURGICAL TREATMENT EVIDENCE Reference Subjects Age BMI or weight (baseline) Intervention 97 40 subjects (26F, 14M) 34y (19-51) 50kg/m2 (39-75) Adjustable silicone gastric band 98 36 patients (the first of any kind of LASGB procedure attempted by this group) Included males, and were African-American 39y (23-53) 44.5kg/m2 (125kg) Laparoscopic adjustable silicone gastric banding 99 Assessment of 25 VBG over 13y in a community hospital practice 44.3kg/m2 Vertical banded gastroplasty 100 125 patients: 80 morbidly obese 45 super-obese Vertical banded gastroplasty 101 166 morbidly obese subjects (35 had VBG) Vertical banded gastroplasty 102 67 morbidly obese patients 103 68 patients (59F, 9M) 256 47.5kg/m2 36y (17-60) Vertical banded gastroplasty 43kg/m2 (37-66) 123kg (89-188) Randomised prospective trial of: laparoscopic vertical banded gastroplasty (n = 34) open vertical banded gastroplasty (n = 34) Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults APPENDIX G – SURGICAL Follow-up TREATMENT EVIDENCE Mortality/morbidity/complications Mean BMI at follow-up was 38.4 at 1y, 40.4 at 4y Excess weight loss was 41% for subjects who had an intact gastric band and continued in the study No deaths 32 reoperations were necessary to maintain efficacy or correct complications At the 4y interval the reoperation rate of 80% was unsatisfactory African-Americans had poor weight loss compared with whites Only subjects achieved a BMI less than 35 and/or at least a 50% reduction in excess weight Average BMI at 1y was 37kg/m2 (n = 28), at 3y was 35.8kg/m2 (n = 15) Average weight loss at 1y was 20kg, at 3y was 27.7kg EBW loss was 38.4% at 3y LASGB devices were removed in 15 patients 10d to 42mo after surgery (mainly due to inadequate weight loss) Complications included oesophageal dilatation, band leakage, infection, erosion, and slippage The authors of this paper did not find LASGB to be an effective procedure After 6.2y, BMI was 34.9kg/m2 (decrease of 9.4kg/m2) 56% of patients were fully satisfied with the results patients lost to follow-up but at last follow-up (3-18mo) they had achieved only 18% EBW loss Weight-loss difference (EBW=excess body weight) No fatalities, no splenic tears, no stomal stenosis, no symptomatic gastroesophageal reflux reoperations, incisional hernias At 2y, greater weight loss in terms ofkg was seen in group 2, although BMI did not fall below 35 Patients in group had a mean BMI below 35 In group many comorbidities completely resolved; however, there was a 2-fold higher remaining morbidity after surgery 100% follow-up % EBW loss was 61% at 1y, 56% at 4y, and 37% at 5y 25% had an overall unsatisfactory outcome Early post-operative morbidity was 5.7% Late post-operative morbidity was 22.8% Many patients had some degree of stomal stenosis No mortality A significant number of patients with excellent weight loss had a high frequency of vomiting Anaemia and iron deficiency were found in 46% and 32% of patients respectively 32.1kg/m2 at 1y but mean BMI was above 35 at 5y Success of laparoscopic gastroplasty was 88.2% (30 out of 34) No difference between procedures in terms of patient’s reduced body weight, BMI or % EBW but data not given in paper Length of follow-up not clear (appears to be 1y) No mortality Intra-operative complications: only one case of gastric bleeding in group Early major complications were 6.6% and 7.8% in groups and 2, respectively Early minor post-operative complications were wound infections only, seen in group patient and group patients At longer follow-up, incisional hernias occurred in 15.8% of patients in group vs none in group Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults 257 APPENDIX H – SOURCES FOR APPENDIXES APPENDIX H 10 11 12 13 14 258 SOURCES FOR APPENDIXES US National Institutes of Health Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: executive summary Expert Panel on the Identification, Evaluation, and Treatment of Overweight in Adults Am J Clin Nutr 1998;68(4):899–917 National Health and Medical Research Council How to review the evidence: systematic identification and review of the scientific literature Canberra: NHMRC, 2000 Egger G, Cameron-Smith D, Stanton R The effectiveness of popular, non-prescription weight loss supplements Med J Aust 1999;171:604–8 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and Obesity in Adults 1—SETTING THE SCENE Evidence-based statement Overweight and obesity. .. is so difficult for obese individuals to maintain weight loss in the long term Clinical Practice Guidelines for the Management of Overweight and Obesity in Adults 1—SETTING 1.7 THE SCENE A B N... Ageing, the NHMRC initiated the development of the guidelines In working on the project, and having determined that separate guidelines were required for adults and for children and adolescents, the