Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--Executive Summary

Summary of Evidence-Based Recommendations

A. ADVANTAGES OF WEIGHT LOSS

The recommendation to treat overweight and obesity is based not only on evidence that relates obesity to increased mortality but also on RCT evidence that weight loss reduces risk factors for disease. Thus, weight loss may not only help control diseases worsened by obesity, it may also help decrease the likelihood of developing these diseases. The panel reviewed RCT evidence to determine the effect of weight loss on blood pressure and hypertension, serum/plasma lipid concentrations, and fasting blood glucose and fasting insulin. Recommendations focusing on these conditions underscore the advantages of weight loss.

1. Blood Pressure

To evaluate the effect of weight loss on blood pressure and hypertension, 76 articles reporting RCTs were considered for inclusion in these guidelines. Of the 45 accepted articles, 35 were lifestyle trials and 10 were pharmacotherapy trials. There is strong and consistent evidence from these lifestyle trials in both overweight hypertensive and nonhypertensive patients that weight loss produced by lifestyle modifications reduces blood pressure levels. Limited evidence exists that decreases in abdominal fat will reduce blood pressure in overweight nonhypertensive individuals, although not independent of weight loss, and there is considerable evidence that increased aerobic activity to increase cardiorespiratory fitness reduces blood pressure (independent of weight loss). There is also suggestive evidence from randomized trials that weight loss produced by most weight loss medications, except for sibutramine, in combination with adjuvant lifestyle modifications will be accompanied by reductions in blood pressure. Based on a review of the evidence from the 45 RCT blood pressure articles, the panel makes the following recommendation:


Weight loss is recommended to lower elevated blood pressure in overweight and obese persons with high blood pressure. Evidence Category A.

2. Serum/Plasma Lipids

Sixty-five RCT articles were evaluated for the effect of weight loss on serum/plasma concentrations of total cholesterol, LDL-cholesterol, very low-density lipoprotein (VLDL)-cholesterol, triglycerides, and HDL-cholesterol. Studies were conducted on individuals over a range of obesity and lipid levels. Of the 22 articles accepted for inclusion in these guidelines, 14 RCT articles examined lifestyle trials while the remaining 8 articles reviewed pharmacotherapy trials. There is strong evidence from the 14 lifestyle trials that weight loss produced by lifestyle modifications in overweight individuals is accompanied by reductions in serum triglycerides and by increases in HDL-cholesterol. Weight loss generally produces some reductions in serum total cholesterol and LDL-cholesterol. Limited evidence exists that a decrease in abdominal fat correlates with improvements in lipids, although the effect may not be independent of weight loss, and there is strong evidence that increased aerobic activity to increase cardiorespiratory fitness favorably affects blood lipids, particularly if accompanied by weight loss. There is suggestive evidence from the eight randomized pharmacotherapy trials that weight loss produced by weight loss medications and adjuvant lifestyle modifications, including caloric restriction and physical activity, does not result in consistent effects on blood lipids. The following recommendation is based on the review of the data in these 22 RCT articles:


Weight loss is recommended to lower elevated levels of total cholesterol, LDL-cholesterol, and triglycerides, and to raise low levels of HDL-cholesterol in overweight and obese persons with dyslipidemia. Evidence Category A.

3. Blood Glucose

To evaluate the effect of weight loss on fasting blood glucose and fasting insulin levels, 49 RCT articles were reviewed for inclusion in these guidelines. Of the 17 RCT articles accepted, 9 RCT articles examined lifestyle therapy trials and 8 RCT articles considered the effects of pharmacotherapy on weight loss and subsequent changes in blood glucose. There is strong evidence from the nine lifestyle therapy trials that weight loss produced by lifestyle modification reduces blood glucose levels in overweight and obese persons without diabetes, and weight loss reduces blood glucose levels and HbAlc in some patients with type 2 diabetes; there is suggestive evidence that decreases in abdominal fat will improve glucose tolerance in overweight individuals with impaired glucose tolerance, although not independent of weight loss; and there is limited evidence that increased cardiorespiratory fitness improves glucose tolerance in overweight individuals with impaired glucose tolerance or diabetes, although not independent of weight loss. In addition, there is suggestive evidence from randomized trials that weight loss induced by weight loss medications does not appear to improve blood glucose levels any better than weight loss through lifestyle therapy in overweight persons both with and without type 2 diabetes. Based on a full review of the data in these 17 RCT articles, the panel makes the following recommendation:


Weight loss is recommended to lower elevated blood glucose levels in overweight and obese persons with type 2 diabetes. Evidence Category A.


B. MEASUREMENT OF DEGREE OF OVERWEIGHT AND OBESITY

Patients should have their BMI and levels of abdominal fat measured not only for the initial assessment of the degree of overweight and obesity, but also as a guide to the efficacy of weight loss treatment. Although there are no RCTs that review measurements of overweight and obesity, the panel determined that this aspect of patient care warranted further consideration and that this guidance was deemed valuable. Therefore, the following four recommendations that are included in the Treatment Guidelines were based on nonrandomized studies as well as clinical experience.

1. BMI To Assess Overweight and Obesity

There are a number of accurate methods to assess body fat (e.g., total body water, total body potassium, bioelectrical impedance, and dual-energy X-ray absorptiometry), but no trial data exist to indicate that one measure of fatness is better than any other for following overweight and obese patients during treatment. Since measuring body fat by these techniques is often expensive and is not readily available, a more practical approach for the clinical setting is the measurement of BMI; epidemiological and observational studies have shown that BMI provides an acceptable approximation of total body fat for the majority of patients. Because there are no published studies that compare the effectiveness of different measures for evaluating changes in body fat during weight reduction, the panel bases its recommendation on expert judgment from clinical experience:


Practitioners should use the BMI to assess overweight and obesity. Body weight alone can be used to follow weight loss, and to determine efficacy of therapy. Evidence Category C.

2. BMI To Estimate Relative Risk

In epidemiological studies, BMI is the favored measure of excess weight to estimate relative risk of disease. BMI correlates both with morbidity and mortality; the relative risk for CVD risk factors and CVD incidence increases in a graded fashion with increasing BMI in all population groups. Moreover, calculating BMI is simple, rapid, and inexpensive, and can be applied generally to adults. The panel, therefore, makes this recommendation:


The BMI should be used to classify overweight and obesity and to estimate relative risk of disease compared to normal weight. Evidence Category C.

3. Assessing Abdominal Fat

For the most effective technique for assessing abdominal fat content, the panel considered measures of waist circumference, waist-to-hip ratio (WHR), magnetic resonance imaging (MRI), and computed tomography. Evidence from epidemiological studies shows waist circumference to be a better marker of abdominal fat content than WHR, and that it is the most practical anthropometric measurement for assessing a patient's abdominal fat content before and during weight loss treatment. Computed tomography and MRI are both more accurate but impractical for routine clinical use. Based on evidence that waist circumference is a better marker than WHR--and taking into account that the MRI and computed tomography techniques are expensive and not readily available for clinical practice--the panel makes the following recommendation:


The waist circumference should be used to assess abdominal fat content. Evidence Category C.

4. Sex-Specific Measurements

Evidence from epidemiological studies indicates that a high waist circumference is associated with an increased risk for type 2 diabetes, dyslipidemia, hypertension, and CVD. Therefore, the panel judged that sex-specific cutoffs for waist circumference can be used to identify increased risk associated with abdominal fat in adults with a BMI in the range of 25 to 34.9. These cutpoints can be applied to all adult ethnic or racial groups. On the other hand, if a patient is very short, or has a BMI above the 25 to 34.9 range, waist cutpoints used for the general population may not be applicable. Based on the evidence from nonrandomized studies, the panel makes this recommendation:


For adult patients with a BMI of 25 to 34.9 kg/m2, sex-specific waist circumference cutoffs should be used in conjunction with BMI to identify increased disease risks. Evidence Category C.

C. GOALS FOR WEIGHT LOSS

The general goals of weight loss and management are to reduce body weight, to maintain a lower body weight over the long term, and to prevent further weight gain. Evidence indicates that a moderate weight loss can be maintained over time if some form of therapy continues. It is better to maintain a moderate weight loss over a prolonged period than to regain from a marked weight loss.

1. Initial Goal of Weight Loss from Baseline

There is strong and consistent evidence from randomized trials that overweight and obese patients in well-designed programs can achieve a weight loss of as much as 10 percent of baseline weight. In the diet trials, an average of 8 percent of baseline weight was lost. Since this average includes persons who did not lose weight, an individualized goal of 10 percent is reasonable. The panel, therefore, recommends that:


The initial goal of weight loss therapy should be to reduce body weight by approximately 10 percent from baseline. With success, further weight loss can be attempted if indicated through further assessment. Evidence Category A.

2. Amount of Weight Loss

Randomized trials suggest that weight loss at the rate of 1 to 2 lb/week (calorie deficit of 500 to 1,000 kcal/day) commonly occurs for up to 6 months.
Weight loss should be about 1 to 2 lb/week for a period of 6 months, with the subsequent strategy based on the amount of weight lost. Evidence Category B.


D. HOW TO ACHIEVE WEIGHT LOSS

The panel reviewed relevant treatment strategies designed for weight loss that can also be used to foster long-term weight control and prevention of weight gain. The consequent recommendations emphasize the potential effectiveness of weight control using multiple interventions and strategies, including dietary therapy, physical activity, behavior therapy, pharmacotherapy, and surgery, as well as combinations of these strategies.

1. Dietary Therapy

The panel reviewed 86 RCT articles to determine the effectiveness of diets on weight loss (including LCDs, very low-calorie diets (VLCDs), vegetarian diets, American Heart Association dietary guidelines, the NCEP's Step I diet with caloric restriction, and other low-fat regimens with varying combinations of macronutrients). Of the 86 articles reviewed, 48 were accepted for inclusion in these guidelines. These RCTs indicate strong and consistent evidence that an average weight loss of 8 percent of initial body weight can be obtained over 3 to 12 months with an LCD and that this weight loss effects a decrease in abdominal fat; and, although lower-fat diets without targeted caloric reduction help promote weight loss by producing a reduced caloric intake, lower-fat diets with targeted caloric reduction promote greater weight loss than lower-fat diets alone. Further, VLCDs produce greater initial weight losses than LCDs (over the long term of >1 year, weight loss is not different than that of the LCDs). In addition, randomized trials suggest that no improvement in cardiorespiratory fitness as measured by VO2 max appears to occur in obese adults who lose weight on LCDs alone without physical activity. The following recommendations are based on the evidence extracted from the 48 accepted articles:


LCDs are recommended for weight loss in overweight and obese persons. Evidence Category A. Reducing fat as part of an LCD is a practical way to reduce calories. Evidence Category A.


Reducing dietary fat alone without reducing calories is not sufficient for weight loss. However, reducing dietary fat, along with reducing dietary carbohydrates, can facilitate caloric reduction. Evidence Category A.


A diet that is individually planned to help create a deficit of 500 to 1,000 kcal/day should be an intregal part of any program aimed at achieving a weight loss of 1 to 2 lb/week. Evidence Category A.

2. Physical Activity

Effects of Physical Activity on Weight Loss

Twenty-three RCT articles were reviewed to determine the effect of physical activity on weight loss, abdominal fat (measured by waist circumference), and changes in cardiorespiratory fitness (VO2 max). Thirteen of these articles were accepted for inclusion in these guidelines. A review of these articles reveals strong evidence that physical activity alone, i.e., aerobic exercise, in obese adults results in modest weight loss and that physical activity in overweight and obese adults increases cardiorespiratory fitness, independent of weight loss. Randomized trials suggest that increased physical activity in overweight and obese adults reduces abdominal fat only modestly or not at all, and that regular physical activity independently reduces the risk for CVD. The panel's recommendation on physical activity is based on the evidence from these 13 articles:


Physical activity is recommended as part of a comprehensive weight loss therapy and weight control program because it: (1) modestly contributes to weight loss in overweight and obese adults (Evidence Category A), (2) may decrease abdominal fat (Evidence Category B), (3) increases cardiorespiratory fitness (Evidence Category A), and (4) may help with maintenance of weight loss (Evidence Category C).


Physical activity should be an integral part of weight loss therapy and weight maintenance. Initially, moderate levels of physical activity for 30 to 45 minutes, 3 to 5 days a week, should be encouraged. All adults should set a long-term goal to accumulate at least 30 minutes or more of moderate-intensity physical activity on most, and preferably all, days of the week. Evidence Category B.

Effects of Physical Activity and Diet on Weight Loss (Combined Therapy)

Twenty-three RCT articles were reviewed to determine the effects on body weight of a combination of a reduced-calorie diet with increased physical activity. Fifteen of these articles were accepted for inclusion in the guidelines. These articles contain strong evidence that the combination of a reduced-calorie diet and increased physical activity produces greater weight loss than diet alone or physical activity alone, and that the combination of diet and physical activity improves cardiorespiratory fitness as measured by VO2 max in overweight and obese adults when compared to diet alone. The combined effect of a reduced calorie diet and increased physical activity seemingly produced modestly greater reductions in abdominal fat than either diet alone or physical activity alone, although it has not been shown to be independent of weight loss. The panel's following recommendations are based on the evidence from these articles:


The combination of a reduced calorie diet and increased physical activity is recommended since it produces weight loss that may also result in decreases in abdominal fat and increases in cardiorespiratory fitness. Evidence Category A.

3. Behavior Therapy

Thirty-six RCTs were reviewed to evaluate whether behavior therapy provides additional benefit beyond other weight loss approaches, as well as to compare various behavioral techniques. Of the 36 RCTs reviewed, 22 were accepted. These RCTs strongly indicate that behavioral strategies to reinforce changes in diet and physical activity in obese adults produce weight loss in the range of 10 percent over 4 months to 1 year. In addition, no one behavior therapy appeared superior to any other in its effect on weight loss; multimodal strategies appear to work best and those interventions with the greatest intensity appear to be associated with the greatest weight loss. Long-term follow-up of patients undergoing behavior therapy shows a return to baseline weight for the great majority of subjects in the absence of continued behavioral intervention. Randomized trials suggest that behavior therapy, when used in combination with other weight loss approaches, provides additional benefits in assisting patients to lose weight short-term, i.e., 1 year (no additional benefits are found at 3 to 5 years). The panel found little evidence on the effect of behavior therapy on cardiorespiratory fitness. Evidence from these articles provided the basis for the following recommendation:


Behavior therapy is a useful adjunct when incorporated into treatment for weight loss and weight maintenance. Evidence Category B.

There is also suggestive evidence that patient motivation is a key component for success in a weight loss program. The panel, therefore, makes the following recommendation:


Practitioners need to assess the patient's motivation to enter weight loss therapy; assess the readiness of the patient to implement the plan and then take appropriate steps to motivate the patient for treatment. Evidence Category D.

4. Summary of Lifestyle Therapy

There is strong evidence that combined interventions of an LCD, increased physical activity, and behavior therapy provide the most successful therapy for weight loss and weight maintenance. The panel makes the following recommendation:


Weight loss and weight maintenance therapy should employ the combination of LCD's, increased physical activity, and behavior therapy. Evidence Category A.

5. Pharmacotherapy

A review of 44 pharmacotherapy RCT articles provides strong evidence that pharmacological therapy (which has generally been studied along with lifestyle modification, including diet and physical activity) using dexfenfluramine, sibutramine, orlistat, or phentermine/fenfluramine results in weight loss in obese adults when used for 6 months to 1 year. Strong evidence also indicates that appropriate weight loss drugs can augment diet, physical activity, and behavior therapy in weight loss. Adverse side effects from the use of weight loss drugs have been observed in patients. As a result of the observed association of valvular heart disease in patients taking fenfluramine and dexfenfluramine alone or in combination, these drugs have been withdrawn from the market. Weight loss drugs approved by the FDA for long-term use may be useful as an adjunct to diet and physical activity for patients with a BMI of >= 30 with no concomitant obesity-related risk factors or diseases, as well as for patients with a BMI of >= 27 with concomitant risk factors or diseases; moreover, using weight loss drugs singly (not in combination) and starting with the lowest effective doses can decrease the likelihood of adverse effects. Based on this evidence, the panel makes the following recommendation:


Weight loss drugs approved by the FDA may be used as part of a comprehensive weight loss program, including dietary therapy and physical activity for patients with a BMI of >= 30 with no concomitant obesity-related risk factors or diseases, and for patients with a BMI of >= 27 with concomitant obesity-related risk factors or diseases. Weight loss drugs should never be used without concomitant lifestyle modifications. Continual assessment of drug therapy for efficacy and safety is necessary. If the drug is efficacious in helping the patient to lose and/or maintain weight loss and there are no serious adverse effects, it can be continued. If not, it should be discontinued. Evidence Category B.

6. Weight Loss Surgery

The panel reviewed 14 RCTs that examined the effect of surgical procedures on weight loss; 8 were deemed appropriate. All of the studies included individuals who had a BMI of 40 kg/m2 or above, or a BMI of 35 to 40 kg/m2 with comorbidity. These trials provide strong evidence that surgical interventions in adults with clinically severe obesity, i.e., BMIs >= 40 or >= 35 with comorbid conditions, result in substantial weight loss, and suggestive evidence that lifelong medical surveillance after surgery is necessary. Therefore, the panel makes the following recommendation:


Weight loss surgery is an option for carefully selected patients with clinically severe obesity (BMI >= 40 or >= 35 with comorbid conditions) when less invasive methods of weight loss have failed and the patient is at high risk for obesity-associated morbidity or mortality. Evidence Category B.


E. GOALS FOR WEIGHT LOSS MAINTENANCE

Once the goals of weight loss have been successfully achieved, maintenance of a lower body weight becomes the challenge. Whereas studies have shown that weight loss is achievable, it is difficult to maintain over a long period of time (3 to 5 years). In fact, the majority of persons who lose weight, once dismissed from clinical therapy, frequently regain it--so the challenge to the patient and the practitioner is to maintain the weight loss. Successful weight reduction thus depends on continuing a maintenance program on a long-term basis. In the past, obtaining the goal of weight loss has been considered the end of weight loss therapy. Observation, monitoring, and encouragement of patients who have successfully lost weight should be continued long term. The panel's recommendations on weight loss maintenance are derived from RCT evidence as well as nonrandomized and observational studies.

1. Weight Maintenance Phase

RCTs from the Behavior Therapy section above suggest that lost weight usually will be regained unless a weight maintenance program consisting of dietary therapy, physical activity, and behavior therapy is continued indefinitely. Drug therapy in addition may be helpful during the weight maintenance phase. The panel also reviewed RCT evidence that considered the rate of weight loss and the role of weight maintenance. These RCTs suggest that after 6 months of weight loss treatment, efforts to maintain weight loss are important. Therefore, the panel recommends the following:


After successful weight loss, the likelihood of weight loss maintenance is enhanced by a program consisting of dietary therapy, physical activity, and behavior therapy which should be continued indefinitely. Drug therapy can also be used. However, drug safety and efficacy beyond 1 year of total treatment have not been established. Evidence Category B.


A weight maintenance program should be a priority after the initial 6 months of weight loss therapy. Evidence Category B.

Strong evidence indicates that better weight loss results are achieved with dietary therapy when the duration of the intervention is at least 6 months. Suggestive evidence also indicates that during dietary therapy, frequent contacts between professional counselors and patients promote weight loss and maintenance. Therefore, the panel recommends the following:


The literature suggests that weight loss and weight maintenance therapies that provide a grater frequency of contacts between the patient and the practitioner and are provided over the long term should be utilized whenever possible. This can lead to more successful weight loss and weight maintenance. Evidence Category C.


F. SPECIAL TREATMENT GROUPS

The needs of special patient groups must be addressed when considering treatment options for overweight and obesity. The guidelines focus on three such groups including smokers, older adults, and diverse patient populations.

1. Smokers

Cigarette smoking is a major risk factor for cardiopulmonary disease. Because of its attendant high risk, smoking cessation is a major goal of risk-factor management. This aim is especially important in the overweight or obese patient, who usually carries excess risk from obesity-associated risk factors. Thus, smoking cessation in these patients becomes a high priority for risk reduction. Smoking and obesity together apparently compound cardiovascular risk, but fear of weight gain upon smoking cessation is an obstacle for many patients. Therefore, the panel recommends that:


All smokers, regardless of their weight status, should quit smoking. Evidence Category A. Prevention of weight gain should be encouraged and if weight gain does occur, it should be treated through dietary therapy, physical activity, and behavior therapy, maintaining the primary emphasis on the importance of abstinence from smoking. Evidence Category C.

2. Older Adults

The general nutritional safety of weight reduction at older ages is of concern because restrictions on overall food intake due to dieting could result in inadequate intake of protein or essential vitamins or minerals. In addition, involuntary weight loss indicative of occult disease might be mistaken for success in voluntary weight reduction. These concerns can be alleviated by providing proper nutritional counseling and regular body weight monitoring in older persons for whom weight reduction is prescribed. A review of several studies indicates that age alone should not preclude treatment for obesity in adult men and women. In fact, there is evidence from RCTs that weight reduction has similar effects in improving cardiovascular disease risk factors in older and younger adults. Therefore, in the panel's judgment:


A clinical decision to forgo obesity treatment in older adults should be guided by an evaluation of the potential benefits of weight reduction for day-to-day functioning and reduction of the risk of future cardiovascular events, as well as the patient's motivation for weight reduction. Care must be taken to ensure that any weight reduction program minimizes the likelihood of adverse effects on bone health or other aspects of nutritional status. Evidence Category D.

3. Diverse Patient Populations

Standard obesity treatment approaches should be tailored to the needs of various patients or patient groups. It is, however, difficult to determine from the literature how often this occurs, how specific programs and outcomes are influenced by tailoring, and whether it makes weight loss programs more effective. After reviewing two RCTs, four cross-sectional studies, and four intervention studies, as well as additional published literature on treatment approaches with diverse patient populations, the panel recommends the following:


The possibility that a standard approach to weight loss will work differently in diverse patient populations must be considered when setting expectations about treatment outcomes. Evidence Category B.


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