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1 OBESITY /00 $ OO BEHAVIORAL TREATMENT OF OBESITY Thomas A. Wadden, PhD, and Gary D. Foster, PhD Americans are struggling with their weight. Twenty-five percent of women and 20% of men are now obese, as judged by a body mass index (BMI) of 30 kg/m2 or greater.43 An additional 40% of men and 25% of women are overweight, defined as a BMI of 25 to 29.9 kg/m2. The figures for obesity represent an astonishing 75% increase in the prevalence of this disorder in the last 15 years As a result, millions of more Americans are likely to experience weight-related health complications, including coronary heart disease, hypertension, non-insulin-dependent diabetes, and osteoarthritis, which cost the United States $40 to $70 billion a year.l6* 48 Investigators have not identified the precise causes of the weight problem in the United States but believe it is attributable to an increasingly sedentary lifestyle and consumption of a high-fat, high-sugar diet.31 Of the two, decreased physical activity is probably the greater culprit. Daily energy expenditure has declined with each major shift in the national economy-from agriculture to manufacturing to service industry to the current information economy.12 Leisure activities have become similarly more sedentary. The average child watches 28 hours of television a week and logs additional downtime playing video games and listening to music.12 These changes, when combined with food and restaurant industries that serve supersized portions of tasty, high-calorie foods, have produced what Brownelllo has called a toxic environment. This article was supported by a National Institute of Mental Health Research Scientist Development Award, NIH grant DK , and NIMH grant P30 MH From the Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania MEDICAL CLINICS OF NORTH AMERICA VOLUME 84 * NUMBER 2 * MARCH

2 442 WADDEN & FOSTER Although some may question this particular characterization, there is no denying the U.S. epidemic of overweight and The behavioral treatment of obesity refers to a set of principles and techniques designed to help overweight individuals reverse the abovedescribed maladaptive eating and activity habits.'" This article describes the components of this approach, reviews the short-term and long-term results of treatment, and examines the combination of behavioral and pharmacologic therapies. It concludes with a discussion of methods to improve the treatment of obesity in primary care practice. The results of behavioral and pharmacologic therapies are evaluated in light of the new goals of obesity management, which are to help overweight individuals achieve a healthier weight, not an ideal one. A growing literature has shown that weight losses as little as 5% to 10% of initial weight are frequently sufficient to improve weight-related complications, including hypertension, type I1 diabetes, and dyslipidemia.3z, 43, It is not necessary to reduce to ideal weight to achieve such benefits, and for most significantly obese individuals, it is not possible.62 A new goal of behavioral treatment, discussed later, is to help obese individuals accept more modest weight losses. ASSUMPTIONS AND PRINCIPLES OF BEHAVIORAL TREATMENT Goal The goal of behavioral treatment is to help obese patients identify and modify eating, activity, and thinking habits that contribute to their excess weight. This approach recognizes that body weight is affected by factors other than behavior. These factors include genetic, metabolic, and hormonal influences14, 53, 57 that likely predispose some persons to obesity and may set the range of possible weights that an individual can achieve. While recognizing that biology may set a range of possible weights, behavior therapy helps obese individuals develop a set of skills (e.g., a low-fat diet, a high-activity lifestyle, a realistic cognitive style) to regulate weight at the lower end of that range, even though patients may remain overweight after treatment. Behavioral approaches are based on the principles of classic conditioning, which posit that behaviors are often prompted by antecedent or simultaneous events, which, if repeated, become strongly linked. For example, eating may be triggered by negative emotions, long periods of dietary restriction, watching a favorite TV show, or socializing with friends. The more often two things are paired together, the stronger the connection between the two so that, eventually, the presence of one triggers the other. For example, after repeatedly eating ice cream while watching a favorite TV show, just seeing a commercial for the favorite show may trigger a craving for ice cream. Behavioral treatment, as described subsequently, attempts to identify and disconnect the triggers

3 BEHAVIORAL TREATMENT OF OBESITY 443 and overeating. The strength of the trigger diminishes over time as the two events are uncoupled. Although eating can be triggered by one factor, it is more typical that a number of factors lead to overeating, as illustrated in the behavior chain in Figure l.lo Only during the last 15 years have cognitive approaches been incorporated into behavioral treatments for obesity. These approaches recognize the importance of thinking patterns in behavior change. The underlying assumption of cognitive approaches is that thoughts (or cognitions) directly affect feelings and behaviors. Simply put, how people think about a situation determines how they feel and what they do about it. What and how obese individuals think are important for behavior change. This basic premise is the foundation of cognitive therapy, which has been shown to be effective across a variety of psychiatric conditions, including depression, anxiety, and bulimia nervosa.6, 7, 23 Hallmarks Behavioral treatment has several distinguishing hallmarks. First, it is goal-directed. It specifies clear goals in terms that can be easily Figure 1. Example of a behavior chain, showing how one behavior, linked to another, can contribute to an overeating episode. What appears to be unexpected dietary lapse can be traced to a whole series of small decisions and behaviors. The behavioral chain also reveals where the individual can intervene in the future to prevent unwanted eating. Thus, this individual might avoid bringing cookies into the house or at least store them out of sight to reduce impulse eating. (From Brownell KD, Wadden TA: The LEARN Program for Weight Control: Special Medication Edition. Dallas, American Health, 1999; with permission.)

4 444 WADDEN & FOSTER measured. A specific goal can be walking three times per week, lengthening meal duration by 5 minutes, or decreasing the number of selfcritical comments. Specific goals facilitate a clear assessment of goal attainment and targeted problem solving. Second, treatment is process oriented. It is more than helping people to decide what they want to accomplish; it is helping them to find how to do so. Once a goal is specified, patients are encouraged to examine factors that help or hinder goal achievement. In cases in which behavior is not implemented, attention is devoted to finding new strategies or to removing roadblocks. This skill-building philosophy conceptualizes weight management as a set of skills to be learned rather than as willpower. Third, behavioral approaches advocate small rather than large changes. This approach is based on the learning principle of successive approximation, in which incremental steps are taken to achieve more distant goals. Making small changes gives patients successful experiences on which to build, rather than attempting drastic changes, which are typically short-lived. COMPONENTS OF BEHAVIORAL TREATMENT Behavioral treatment usually includes multiple components, such as self-monitoring, nutrition, stimulus control, slowing eating, exercise, problem solving, and cognitive restructuring. These components comprise the behavioral package, which has been summarized in self-help manuals, such as the LEARN Program for Weight ControZ.lo Given the availability of such manuals, as well as extensive reviews of behavioral 77 here only three components of behavioral treatment are briefly reviewed: self-monitoring, exercise, and cognitive restructuring. Self-Monitoring Self-monitoring is the cornerstone of behavioral treatment.'l, 68 Although self-monitoring is used for eating, exercise, and thinking patterns, the focus here is on the self-monitoring of food intake. Several studies have shown that self-monitoring of intake correlates with successful long-term weight Initially, patients are instructed to keep daily records of their food intake (without attempting to change their diet), including the type, amount, and caloric content. Patients then reduce their calorie intake by approximately 500 to 700 kcal (2093 to 2930 kj) per day to achieve a weight loss of approximately 1 lb (0.45 kg) per week. Over time, patients record information about times, places, and feelings associated with eating. Such records are critical because they provide the information necessary to identify the various components of the behavior chain (see Fig. 1) and provide targets for interventions. Accurate record keeping also serves to decrease, although not eliminate,

5 BEHAVIORAL TREATMENT OF OBESITY 445 the tendency of lean and obese persons to underestimate their food intake (by approximately 20% and 40%, respectively5). Exercise Although counterintuitive, the addition of regular exercise to a balanced deficit diet increases weight loss only slightly (i.e., 2 kg) over 16 to 20 weeks,45, 71 as compared with diet alone. This finding is not entirely unexpected, given that it requires more than 40 miles of walking to burn 1 kg of fat. Unrealistic expectations about the effects of exercise on weight loss need to be corrected to prevent patients from becoming disappointed and discontinuing exercise. The true benefits of exercise are for improving health and facilitating the maintenance of weight IOSS.~~, 51, Numerous studies have shown that persons who maintain their weight loss exercise regularly, whereas weight regainers do not:5, Establishing a regular pattern of physical activity is among the most important goals of the behavioral treatment of obesity. The behavioral approach to physical activity is that any activity is better than none. Rather than worrying about reaching some activity threshold (e.g., 30 minutes at 80% of maximum heart rate), efforts are directed toward increasing activity along a continuum. This goal can be accomplished by increasing programmed or lifestyle activity. Programmed activity typically consists of aerobic exercise (e.g., walking, biking, or swimming), engaged in for a set period of time (i.e., 20 to 40 minutes) at a relatively high-intensity level (i.e., 60% to 80% of maximum heart rate) that is planned ahead of time. Lifestyle activity involves becoming more active during the course of one s daily routine, as follows: Take the stairs Stand while on the telephone Put away the remote control Get off the bus a stop early Choose active vacations Avoid using children as fetch-its Take the long way around Choose outdoor activities Make several trips up the stairs Answer the phone in another room Hand deliver messages Park further away from entrances Use a bathroom further away Go out for entertainment (i.e., museums, fairs) Move during commercials Wash the car The principal goal of lifestyle activity is to increase energy expenditure, without concern for the intensity of activity.22 Andersen et ap

6 446 WADDEN & FOSTER reported that programmed and lifestyle activity (when combined with a 1200 kcal/ d diet) produced similar weight losses-approximately 8.5 kg-during a 16-week behavioral program. There was a (nonsignificant) trend for lifestyle activity to be associated with better maintenance of weight loss 1 year after treatment. In addition, Jakicic et ap3 have shown that several short bouts (i.e., four bouts of 10 minutes) of daily walking may be associated with better exercise adherence than a single long bout (i.e., 40 minutes). Clinical experience suggests that lifestyle activity provides an excellent alternative for obese individuals who report that they "hate to exercise." Cognitive Restructuring Cognitive restructuring teaches patients to identify, challenge, and correct the irrational thoughts that frequently undermine weight control efforts. These thoughts tend to occur in two principal areas: dealing with setbacks and accepting less-than-desired weight losses. Cognitive techniques are particularly helpful in dealing with lapse or setback situations. The interventions focus on accurately identifying the setback for what it is-a temporary lapse from which it is possible to recover. Once the event has been realistically assessed, efforts are directed at examining how the lapse occurred and how it can be prevented in the future. These strategies help to avoid the cognitive styles of catastrophizing ("I've blown it") and denial ("It's nothing to worry about"), neither of which is helpful for long-term weight control. Cognitive techniques have been used to help patients accept smaller-than-desired weight losses. It has been shown that, before treatment, patients chose goal weights that would have required a 32% reduction in body weight to achieve.26 Weight losses of 25% were considered only acceptable, and a 17% weight loss was classified as disappointing and unsuccessful in any way. Most behavioral programs now incorporate education about factors that may limit weight loss as well as skillbuilding to counter unrealistic cognitions (e.g., "I won't be happy until I can wear a size 6 dress"; "If a 20-lb weight loss is good, a 40-lb weight loss will be twice as good"; "I can weigh whatever I want if I work hard enough). Cognitive approaches to improving body image and fostering a weight-independent sense of self appear to be helpful in modifying unrealistic expectations. Two self-help books for patients are extremely useful in this regard.l5* 34 RESULTS OF BEHAVIORAL TREATMENT Short-Term Results Table 1 summarizes the results of behavioral treatment from 1974 to 1995, as determined from randomized clinical trials published in

7 BEHAVIORAL TREATMENT OF OBESITY 447 Table 1. SUMMARY ANALYSIS OF RANDOMIZED CLINICAL TRIALS OF GROUP BEHAVIOR THERAPY FOR OBESITY No. studies Sample size Initial weight (kg) Length of treatment (wk) Weight loss (kg) Loss per week (kg) Attrition (%) Length of follow-up (wk) Loss at follow-up (kg) *All studies sampled were published in the following four journals: Addictive Behaviors, Behavior Therapy, Behaviour Research and Therapy, and Journal of Consulting and Clinical Psychology. All values, except for number of studies, are weighted means. Studies with larger sample sizes had a greater impact on the mean values than did studies with smaller sample sizes. Data adapted and updated from Brownell KD, Wadden TA: The heterogeneity of obesity: Fitting treatments to individuals. Behav Ther 22: four journals-addictive Behaviors, Behavior Research and Therapy, Behavior Therapy, and Journal of Consulting and Clinical Psychology. Only studies representative of standard behavioral treatment are included in the table. The data indicate that patients currently treated by a comprehensive group, behavioral approach lose approximately 8.5 kg (about 9% of initial weight) in 20 weeks of treatment.62 About 80% of patients who begin treatment complete it. Behavior therapy yields favorable results as judged by the new criteria for success (i.e., a 5% to 15% reduction in initial weight) proposed by the World Health Organization the Dietary Guidelines for Americans,2 and the Institute of Medicine of the National Academy of Sciences.32 A comparison of early (i.e., 1970s) and more recent ( ) studies reveals that weight losses have more than doubled over the past 20 years as treatment duration has doubled. For example, in 1974, treatment of 8.4 weeks was associated with a mean loss of 3.8 kg, whereas therapy from averaged 22.2 weeks and produced a mean loss of 8.5 kg. Although several new components, including cognitive therapy, have been added to the behavioral approach since 1974, the most parsimonious explanation for the larger weight losses is the longer duration of treatment. The rate of weight loss has remained constant over the past two decades at about 0.4 to 0.5 kg per week. The desire for larger weight losses led, beginning in the mid-l980s, to the use in behavioral programs of portion-controlled, very-low-calorie diets (VLCD), usually served in liquid form.4l. 63 These diets provide large amounts of dietary protein, to spare the loss of lean body mass, and induce weight losses of 20 to 25 kg (about 20% of initial weight) in 12 to 16 weeks. At least seven studies have compared the results of a VLCD with those of a 1200 to 1500 kcal/d balanced deficit diet (BDD) composed of conventional foods.21, 39, 59, 66* 70, 78, 79 With one exception, 39 the

8 448 WADDEN & FOSTER studies found that patients treated by the VLCD lost approximately twice as much weight as those who received the 1200 to 1500 kcal/d BDD. One or more years after treatment, however, patients who received the VLCD had regained significantly more weight than those treated by the BDD, such that the long-term weight losses produced by the two interventions were essentially equal. Cost-effectiveness studies are needed to compare the benefits and risks of these two approaches over a period of 3 or more years. Such data could reveal whether it is beneficial to induce losses greater than the 5% to 10% currently recommended by WHOB1 and other scientific bodies. Long-Term Results Weight regain is a problem following virtually all diet and exercise interventions, not only a VLCD. As shown in Table 1, patients treated for 20 weeks by behavior therapy typically regain about 30% to 35% of their weight loss in the year after treatment.62 By 5 years, 50% or more of patients are likely to have returned to their baseline Although these results are discouraging, they are not entirely surprising when the treatment of obesity is compared with that of other chronic disorders. Few practitioners, for example, would expect 20 weeks of antihypertensive medication to provide adequate control of blood pressure 1 year, or even 1 month, after medication was terminatedp The same holds true of the treatment of type I1 diabetes. In both cases, continuous, long-term care is needed.47 When long-term treatment-in the form of behavior therapy, pharmacotherapy, or the combination-is similarly applied to obesity, the maintenance of weight loss improves significantly. LONG-TERM BEHAVIORAL TREATMENT Several studies have demonstrated the benefits of long-term behavioral treatment.46, 76 Perri and for example, found that patients who attended every-other-week group maintenance sessions for the year after weight reduction maintained 13.0 kg of their 13.2-kg endof-treatment weight loss, whereas those who did not receive such therapy maintained only 5.7 kg of a 10.8-kg loss. Studies by Wadden et ap and Wing et a176 similarly showed excellent maintenance of weight loss while subjects attended either weekly or biweekly follow-up sessions. Maintenance sessions appear to provide patients with the support and motivation needed to continue to practice weight-control skills, which include keeping food records, exercising regularly, eating a low-fat diet, and measuring and recording their weight at least once weekly (if not more often).61 Table 2 summarizes the results of four studies in which patients were treated for 1 year or more by weekly or biweekly group behavior therapy.

9 BEHAVIORAL TREATMENT OF OBESITY 449 Table 2. MEAN PERCENTAGE REDUCTION IN INITIAL WEIGHT FOR PATIENTS TREATED FOR 1 OR MORE YEARS BY WEEKLY OR EVERY-OTHER-WEEK BEHAVIOR THERAPY Maximum % Lost During % Lost At Study N* Treatment Treatmentt Last Visit* Perri et a146 25/19 wk 1-20: LCD + weekly 14% at wk 20 13% at wk 72 group behavior therapy; wk 21-72: LCD + biweekly Viegener et a160 43/30 maintenance therapy wk 1-26: LCD + weekly group behavior therapy; wk 27-52: LCD + biweekly maintenance therapy 9% at wk 26 9% at wk 52 Wadden et ap7 21/17 wk 1-52: LCD + weekly 14% at wk 52 12% at wk 78 group behavior therapy; wk 53-78: LCD + biweekly maintenance therapy Wing et a178 48/41 wk 1-52: LCD + weekly 13% at wk 26 10% at wk 52 group behavior therapy *Number of patients who began and completed treatment. tmaximum percentage reduction in initial weight and the time at which it occurred. Percentages were calculated by dividing mean weight loss by patients mean initial weight. $Percentage reduction in initial weight at time that patients were assessed at the last weight maintenance visit. LCD = Low-calorie diet (i.e., kcal/d) of conventional foods. Long-term behavioral treatment clearly improves the maintenance of weight loss, but it does not increase the magnitude of weight loss. The authors research team had anticipated that patients treated weekly for 1 year by group behavior therapy would lose 20 to 25 kg, equal to a 20% to 25% reduction in initial weight.66 This loss was expected based on multiplying the average weekly loss of 0.4 to 0.5 kg (shown in Table 1) by 52 weeks. Instead, patients reduced a maximum of 14.4 kg (13.6% of initial weight) and lost most of this during the first 26 weeks. These findings are consistent with others summarized in Table 2 and indicate that there are limits to the size of the weight losses than can be expected (for most patients) with long-term behavioral treatment. NATIONAL WEIGHT CONTROL REGISTRY Larger long-term weight losses have been reported for participants enrolled in the National Weight Control Registry, directed by Wing and Hill.36 The Registry seeks to identify individuals nationwide who have lost a minimum of 13.6 kg (i.e., 30 lb) and maintained the loss for at

10 450 WADDEN & FOSTER least 1 year. The approximately 800 individuals identified to date have lost a mean of 30 kg, which they have maintained for 5 years. With weight loss, women achieved an average BMI of 24 kg/m2 and men a BMI of 26 kg/mz. Participants uniformly report that they consume a low-calorie diet (i.e., 1300 kcal/d for women and 1725 kcal/d for men) and expend about 2825 kcal a week in purposeful physical activity. This expenditure is the equivalent of walking about 28 miles a week. Thus, participants in the National Registry engage in the activities that are encouraged by long-term behavioral treatment.47 Results of the Weight Control Registry may provide hope and inspiration to significantly obese individuals who wish to reduce closer to average or ideal weight. Further studies, however, are needed to determine how representative the experiences of Registry participants are of obese individuals in the general population who attempt to lose weight. The results are not representative of those achieved with university-based and hospital-based programs. LONG-TERM BEHAVIORAL AND PHARMACOLOGIC TREATMENT Long-term group behavioral treatment is effective but has two significant shortcomings. First, it is offered by only a small number of university and hospital clinics, limiting patients access to care. Second, patients appear to tire of behavioral treatment after the first 6 months or so. This tiring is suggested by poor treatment attendance rates during the latter half of programs. Several studies found that patients attended approximately half as many sessions during the last several months of treatment as compared with the first several months.44, 66, These shortcomings have led the authors research team to explore alternative methods of facilitating the maintenance of weight loss. Pharmacotherapy holds promise in this regard. Fen-Phen Experience Interest in the pharmacologic treatment of obesity was awakened in 1992 by the demonstration of Weintraub et a174 that small doses of fenfluramine and phentermine (i.e., fen-phen), when combined with a comprehensive program of group behavior modification, induced an average loss of 16% of initial weight in approximately 6 months. More impressive was the finding that patients who remained on medication for 3 years maintained approximately two thirds of their weight loss at the end of this time, an outcome substantially more favorable than that for traditional group behavior m~dification.~~ The subsequent withdrawal from the market of fenfluramine and dexfenfluramine, because of their association with valvular heart disease,* negated the clinical significance of Weintraub s findings. The fenfluramines clearly were the

11 BEHAVIORAL TREATMENT OF OBESITY 451 wrong medication; Weintraub, however, may have identified the right model of care-long-term pharmacotherapy-provided that safe and effective medications could be identified. Two such medicationssib~tramine~~ and orlistap4 have been approved for long-term use in the United States and various European nations, and numerous other agents are under development. Sibutramine and Orlistat Sibutramine is associated with losses of approximately 7% to 8% of initial weight in 6 months and with the maintenance of these losses at 1 year in patients who remain on medi~ation.~~ The medication, which is a combined serotoninergic-noradrenergic reuptake inhibitor, reduces food intake, apparently by enhancing satiety. Orlistat is a gastric lipase inhibitor, which inhibits the absorption of approximately 30% of the fat contained in a The medication induces a weight loss of approximately 10% of initial weight in the first 6 to 12 months of treatment. With continued use of orlistat, patients in two studies maintained a loss of approximately 8% of initial weight at 2 years.19, 54 Several reviews of the pharmacologic treatment of obesity have appeared,9,28,42,49 including one in this volume. An article by the National Task Force on the Prevention and Treatment of Obesity provides detailed recommendations for identifying patients for whom medications may be appro~riate.~~ Discussion here is limited to the relationship between behavioral and pharmacologic interventions for obesity and potential methods of combining these two interventions in primary care practice. Pharmacologic Versus Behavioral Treatment Current pharmacologic agents induce weight loss by modifying internal signals that regulate hunger or satiety (as with sibutramine) or by causing nutrient malabsorption (as with orlistat). Several patients, for example, whom the authors have treated with sibutramine, have reported that the medication decreased their preoccupation with food and blunted their responsiveness to the sights and smells of food. Behavior modification, by contrast, induces weight loss by helping patients modify the external en~ir0nment.l~ Patients, for example, are instructed to take smaller portion sizes, to avoid convenience stores and fast-food restaurants, to store foods out of sight, and to avoid engaging in other activities while eating. The desire to eat is controlled by limiting exposure to events that precipitate eating. Pharmacotherapy and behavior therapy would appear to induce weight loss by different but potentially complementary Combining the two approaches could produce better weight management than either intervention alone. This belief is supported by the results of a study by Craighead et a1.18 Patients who were treated weekly for 26 weeks by group behavior

12 452 WADDEN & FOSTER modification alone (i.e., without medication) lost an average of 11% of initial weight. Those treated for the same duration by pharmacotherapy alone (up to 120 mg/d dl-fenfluramine), in brief monthly office visits, lost a significantly smaller 7%. The combination of dl-fenfluramine plus weekly group behavior modification resulted in a mean weight loss of 16% of initial weight. Medication and behavior therapy appeared to have additive effects. The authors research team has obtained similar effects in a study of sibutramine. Fifty-five obese women all were prescribed 15 mg/d of sibutramine and were randomly assigned to one of three conditions. Those in a medication-alone group met with a physician approximately once a month for 5- to 10-minute visits during which their weight and vital signs were measured. Patients were instructed to consume approximately 1200 kcal/d and to walk (eventually) 150 minutes a week. The physician did not provide any behavioral counseling (i.e., patients were not given treatment manuals, and no food or activity records were collected). Patients in a second condition received the same medical monitoring and diet and exercise prescription but also attended weekly group behavior modification (BMOD) sessions for the first 5 months and monthly sessions thereafter. Treatment sessions for this medication-plus- BMOD condition were conducted using the LEARN Program for Weight Control (Special Medication Edition),I3 a copy of which was provided to participants. Patients in a third condition received this same intervention but, for the first 4 months, were also given a 1000 kcal/d portioncontrolled diet. It consisted of four servings daily of a nutritional supplement (OPTIFAST 800, Novartis Nutrition, Minneapolis, MN), which was combined with an evening meal of food (which included a frozen food entree and a vegetable and a fruit serving). Participants in this combinedtreatment condition completed weekly food and exercise logs, as did those in the second condition. After the first 6 months, patients in the three conditions had reduced their initial weight by 5.9%, ll.6yo, and 17.8%. Participants who received medication plus BMOD lost significantly more weight (i.e., 11.6%) than those treated by medication alone (i.e., 5.9%). This finding underscores the importance of combining medication with patients own efforts to improve their eating and activity habits; medication alone is unlikely to yield optimal results. Patients who received combined treatment lost significantly more weight than those in the two other conditions, revealing the benefits of using a portion-controlled diet. These patients are being followed for an additional 6 to 12 months to determine whether sibutramine facilitates the maintenance of weight loss induced by combined treatment. The study design does not include a placebo and cannot provide a definitive test of the benefits of sibutramine for weight maintenance. Patients in previous studies, who were treated by a 1000 kcal / d portion-controlled diet but without medication, regained 40% to 55% of their weight loss in the year after treatment. If patients in the current study regain less than 25% of their weight, the combined behavioral-pharmacologic treatment would appear promising.

13 BEHAVIORAL TREATMENT OF OBESITY 453 BEHAVIORAL AND PHARMACOLOGIC TREATMENT OF OBESITY IN PRIMARY CARE Although behavior modification may improve the results of pharmacotherapy, few primary care practices are equipped to provide such group treatment, and individual physicians may be similarly unprepared to provide lifestyle counseling during routine office visits. The authors' research team investigated the feasibility of combining medication with lifestyle counseling provided during brief individual office visits.65 This approach was compared with medication combined with traditional group behavior modification. Because this study used the fenfluraminephentermine combination, the results are of limited clinical value. The findings reported here, however, are representative of those that may be obtained using newer weight-loss agents, such as sibutramine or orlistat. Twenty-six obese women were prescribed 60 mg / d of fenfluramine and 15 mg/d of phentermine, as well as a 1200-kcal/d diet. In addition, all women were provided copies of the LEARN Program for Weight Control.lo Treatment differed in that half the women, assigned at random, attended a total of 32 (75-minute) group behavior modification sessions during the year of treatment. Participants in a second condition met individually with a physician (i.e., a psychiatrist) for 15 to 20 minutes on each of only 10 occasions (weeks 1, 2, 4, 6, 10, 18, 26, 34, 42, and 52). They, similar to the patients in group treatment, were given specific homework assignments to be completed before their next office visit. All participants were asked to keep records of their food intake and to increase their walking (to an eventual goal of 150 to 180 minutes a week). At the end of 1 year, patients in both conditions had lost large amounts of weight-about 16% of initial weight for those who received group behavior modification and 15% for those treated in individual physician visits. Patients treated in 10 brief but structured physician visits achieved the same highly successful results at 1 year as persons who attended 32 group behavior therapy sessions. These results need to be replicated in a larger sample (which includes men and women), using safe medication and using primary care physicians rather than psychiatrists as treatment providers. The findings, however, strongly suggest that primary care physicians could effectively treat obese patients by combining medication with brief, protocol-guided lifestyle counseling. Facilitating Medication Adherence In addition to improving patients' eating and exercise habits, behavioral principles may help facilitate medication adherence. This is an important issue, given findings, for example, that as many as half of persons prescribed antihypertensive agents do not achieve optimal control of blood pressure because of inadequate medication adherence.20

14 454 WADDEN & FOSTER Practitioners may wish to review several issues with patients when prescribing weight loss agents? 27 as follows: 1. Discussing the mechanism by which the weight-loss medication works. This includes describing what the medication will do (i.e., increase satiety or block fat absorption), as well as what the patient should do (i.e., decrease exposure to food triggers, record food intake). 2. Noting the medication s possible side effects and how the patient should respond to them. This includes having patients call the practitioner before they stop taking the medication. 3. Asking whether the patient or the patient s family has any healthrelated concerns about the use of medications (particularly in view of the adverse effects of the fenfluramines) or about the costs of medication (which are not covered by most insurance plans). 4. Describing the course of treatment, at least for the first year, and outlining medication use, the frequency of office visits, and behavioral goals of treatment. 5. Developing a medication schedule that identifies when and where patients will take the medication and what they should do in the event of missed doses. The more concrete the schedule, the better patients adherence. 6. Having patients keep a daily medication log, at least during the first few months.20 This log should be reviewed at subsequent office visits. The best adherence usually occurs when the patient and provider discuss the aforementioned issues in a collaborative manner. The practitioner can actively involve the patient in deciding whether to use medication, as well as in developing a medication schedule. IMPROVING WEIGHT MANAGEMENT IN PRIMARY CARE PRACTICE This section reviews some practical aspects of providing obesity treatment in primary care practice, including conducting a behavioral assessment, talking empathically with patients about weight control, and creating an office that is user-friendly for obese individuals. Assessment A National Institutes of Health report, prepared by the National Heart, Lung, and Blood 1nstitute:O provides an excellent summary of the physical examination and risk assessment that should be conducted on obese individuals before their beginning weight reduction.

15 BEHAVIORAL TREATMENT OF OBESITY 455 Mood and Behavior Approximately 30% of obese patients who seek weight reduction suffer from significant depression or other psychologic disturban~e.~~ Emotional distress is frequently associated with binge eating, in which an individual eats a large amount of food in a short period of time and feels out of control while doing so.82 The presence of binge eating may be assessed using the Questionnaire on Eating and Weight Patterns, developed by Spitzer et ap5 Practitioners are encouraged to inquire routinely about the obese patient s mood, sleep, appetite, and enjoyment of activities, as well as pattern of eating. Overweight individuals with symptoms of depression, anxiety, or binge eating may require pharmacotherapy or treatment by a mental health professional before attempting to lose weight. Readiness A patient may need to lose weight but not be ready to make a commitment to doing so. It is important for the practitioner to assess if patients are ready for weight loss, rather than implicitly assuming that they are. Reviewing findings of the physical examination, laboratory tests, and history can help educate patients about the need for weight reduction. It is also important to determine whether it is a favorable time for the patient to lose weight. Weight loss requires concentration and sustained effort, which are often impaired by the occurrence of life stressors, such as a job change, financial problems, or a major family illness.67 If such stressors are present, the immediate goal of treatment is the prevention of further weight gain rather than the induction of weight loss. Setting Realistic Goals and Treatment Expectations Before initiating treatment, the practitioner should examine patients reasons for and expectations of weight loss. This examination includes determining how much weight patients expect to lose, as well as changes in physical or psychological status that are anticipated. Patients satisfaction with treatment is based on comparing what is obtained with what was expected. From this perspective, patients probably will be happier with their weight loss if the provider first helps them set realistic expectations. As noted previously, a realistic goal, for most obese individuals, is to lose 5% to 10% of initial weight. In addition to clarifying patients expectations for weight loss, practitioners should outline the prescribed course of treatment, describe the behavioral demands of the program (e.g., self-monitoring, decreasing energy intake, and increasing activity), and discuss the risks and benefits of the approach selected.

16 456 WADDEN -31 FOSTER Talking With Patients About Weight Control No matter what type of obesity treatment is ultimately recommended, effective and compassionate treatment of obese patients requires an understanding of the cultural context in which treatment occurs.73 As Stunkard and S0ba1~~ have suggested, disparagement of obese individuals is the last socially acceptable form of prejudice. A My Turn column in Newsweek exemplifies society s contempt for the obese: This information [about genetic determinants of obesity] should be withheld from the fat multitudes because the obese will latch onto any excuse for failing to lose weight.... Face it Chubbo, when was the last time you were f~rce-fed?~~ Health care providers seem to share society s negative view of the overweight. Although the literature on this topic suffers from the use of unvalidated questionnaires, unspecified definitions of obesity, and nonrandom samples, the findings are remarkably consistent. Maddox and Liederman38 found that more than half of physicians described their obese patients as weak-willed (60%), ugly (54%0), or awkward (55%). In a more recent study, 63% of family practice physicians attributed obesity to a lack of willpower, and more than a third described their obese patients as lazy.50 The experience of obese patients in a medical setting has been less examined. In a study by Rand and Ma~Gregor,~~ morbidly obese patients were asked a series of questions about how they had been treated by various members of society. One such item was, I have been treated disrespectfully by the medical profession because of weight. Only 6% of patients responded never, whereas 77% responded either usually or always. Participants in that study also reported that they had been the target of rude and degrading remarks by professionals, such as: How can I tell if you re pregnant? With this mountain of fat I can t feel anything and All your problems are due to your gross fat. It is possible that negative experiences may prevent obese person from obtaining medical care. Adams et all found that only 47.5% of very overweight women received annual pelvic examinations in the last 2 years as compared with 68.1% of average-weight women, a disturbing tendency given the higher rate of gynecologic concerns in obese women.48 Toward More Empathic Encounters It can be argued that overweight patients are just too sensitive, and their perceptions about medical visits reflect their own frustration with their weight, rather than any systemic bias by health care professionals. Even if patients bad experiences are, in part, due to their inaccurate perceptions, such experiences need to be remedied because they lead to interactions that, at best, provide medical care at the expense of a patient s self-esteem or, at worst, prevent obese patients from seek-

17 BEHAVIORAL TREATMENT OF OBESITY 457 ing health care alt~gether.~~ The following recommendations, based on the available research, as well as the authors own clinical experience, seek to put obese patients at ease in the medical setting and promote competent, compassionate care: Assume that obese individuals know they are overweight. If they have not heard it from a health care professional, they have probably been told by friends, family, or even strangers. Listen carefully to the patient s presenting problem, independent of weight. Few patients consider weight to be their primary problem. As St~nkard~~ points out, patients define the presenting problem. If weight is a precipitating factor, focus on the factors that affect the presenting problem and weight. For example, it is not likely to be useful to tell an obese patient with dyslipidemia to lose weight. Encouraging the same patient to decrease the intake of saturated fat and make small changes in activity, however, will likely influence weight and lipids. Such advice is better received by patients who are often told to lose weight in response to many medical problems. Provide the same care to obese individuals as to nonobese patients. Lean individuals with hypertension or type 2 diabetes are encouraged to watch their diet but are also provided appropriate medication for their conditions. Obese patients with these complications should be provided the same medications. Too often they are told to lose weight, and appropriate pharmacologic care is not provided in a timely manner. Do not blame patients for a less-than-desired outcome. If patients do not lose weight, do not give up on them. Help them understand what got in the way and how such barriers could be removed. Patients benefit more from examining how behavior changed or did not change rather than focusing on why things did not go as planned. Creating a User-Friendly Office Just as airline seats are frequently too small for significantly obese patients, so are the equipment and furnishings found in many medical practices. Attention to the following details facilitates patient care: Have a scale that can weigh all patients. Getting weighed is among the most unpleasant experiences for an obese patient in the medical setting; it becomes tortuous and humiliating if a patient weighs more than the scale can accommodate. Have gowns available that fit larger patients. Many obese patients report the experience of waiting for a physician examination in a gown that barely covers them. Use larger blood pressure cuffs when appropriate. Office staff should know when to use larger cuffs with patients. Inappropriate cuff sizes lead to inaccurate measurements and treatment recommendations. Provide some armless chairs in the waiting room. Obese patients should not be made to feel uncomfortable in chairs made for lean persons.

18 458 WADDEN & FOSTER CONCLUSION The use in primary care practice of behavior modification or behavior modification combined with pharmacotherapy holds promise of improving the treatment of significantly obese patients. In addition, practitioners owe it to their obese patients to stay current on the latest research and to be sure that society s prejudices against obese persons do not influence their clinical care. In short, obese patients deserve to be treated with the same respect and concern as individuals with other chronic disorders. The more practitioners communicate that they understand what a challenging and frustrating problem weight control is, the more obese patients will feel supported and understood. ACKNOWLEDGMENTS The authors thank Suzanne Phelan, MA, for her excellent editorial assistance. The authors both serve on the speakers bureaus of Knoll Pharmaceutical Co. and Roche Laboratories, which manufacture sibutramine and orlistat, respectively. References 1. Adams CH, Smith NJ, Wilbur DC, et al: The relationship of obesity to the frequency of pelvic examinations: Do physician and patient attitudes make a difference? Women Health 20:45-57, Agricultural Research Service: Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans Andersen RE, Wadden TA, Bartlett SJ, et al: Effects of lifestyle activity vs. structured aerobic exercise in obese women: A randomized trial. JAMA 281: , Baldessarini RJ: Enhancing the treatment with psychotropic medications. Bulletin of the Menninger Clinic , Bandini LG, Schoeller DA, Cyr HN, et al: Validity of reported energy intake in obese and non-obese adolescents. Am J Clin Nutr 121:91-106, Beck AT, Emery G, Greenberg R Anxiety Disorders and Phobias: A Cognitive Perspective. New York, Basic Books, Beck AT, Rush A, Shaw 8, et al: Cognitive Therapy of Depression. New York, Guilford Press, Bowen R, Glicklich A, Kahn M, et al: Cardiac valvulopathy associated with exposure to fenfluramine or dexfenfluramine: U.S. Department of Health and Human Services Interim Public Health Recommendations. MMWR Morb Mortal Wkly Rep 46: , Bray GA: Use and abuse of appetite-suppressant drugs in the treatment of obesity. Ann Intern Med 119: , Brownell KD: The LEARN Program for Weight Control, ed 7. Dallas, American Health, Brownell KD, Wadden TA: The heterogeneity of obesity: Fitting treatments to individuals. Behav Ther 22: , Brownell KD, Wadden TA: Understanding and treating obesity: A serious, prevalent, and refractory disorder. J Consult Clin Psycho1 60: , Brownell KD, Wadden TA: The LEARN Program for Weight Control: Special Medication Edition. Dallas, American Health, Campfield LA, Smith FJ, Guisez Y, et al: Recombinant mouse OB protein: Evidence for a peripheral signal linking adiposity and central neural networks. Science 269: , 1995

19 BEHAVIORAL TREATMENT OF OBESITY Cash TF: The Body Image Workbook: An 8-Step Program for Learning to Like Your Looks. Oakland, New Harbinger, Colditz GA: Economic costs of obesity. Am J Clin Nutr 55: , Craighead LW, Agras WS: Mechanisms of action in cognitive-behavioral and pharmacological interventions for obesity and bulimia nervosa. J Consult Clin Psychol 59: , Craighead LW, Stunkard AJ, OBrien RM: Behavior therapy and pharmacotherapy for obesity. Arch Gen Psychiatry 38: , Davidson MH, Hauptman J, DiGirolamo M, et al: Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: A randomized controlled trial. JAMA 281: , Dunbar JM, Stunkard AJ: Adherence to diet and drug regimen. In Levy R, Rifkind B, Dennis B, et a1 (eds): Nutrition, Lipids and Coronary Heart Disease. New York, Raven Press, 1979, pp EDIC Research Group: Manual of Operations. Rockville, MD, EDIC, Epstein LH, Cluss PA, Wing R, et al: A comparison of lifestyle change and programmed aerobic exercise on weight and fitness changes in obese children. Behav Ther 13: , Fairbum CG, Wilson GT Binge Eating: Nature, Assessment and Treatment. New York, Guilford Press, Fitzgibbon ML, Stolley MR, Kirschenbaum DS: Obese people who seek treatment have different characteristics than those who do not seek treatment. Health Psychol 12: , Foster GD, Johnson C: Facilitating health and self-esteem among obese patients. Prim Psychiatry 5:89-95, Foster GD, Wadden TA, Vogt RA, et al: What is a reasonable weight loss? Patients expectations and evaluations of obesity treatment outcomes. J Consult Clin Psychol 65:79-85, Frank E: Alliance not compliance: A philosophy of outpatient care. J Clin Psychiatry , Goldstein DJ, Potvin JH: Long-term weight loss: The effect of pharmacologic agents. Am J Clin Nutr 60: , Grilo CM, Brownell KD, Stunkard AJ: The metabolic and psychological importance of exercise in weight control. In Stunkard AJ, Wadden TA (eds): Obesity: Theory and Therapy, ed 2. New York, Raven Press, 1993, pp Hecht K Oh, come on fatties. Newsweek, Sept. 3, p 8, Hill JO, Peters JC Environmental contributions to the obesity epidemic. Science 280: , Institute of Medicine: Weighing the Options: Criteria for Evaluating Weight Management Programs. Washington, D.C., Government Printing Office, Jakicic JM, Butler BA, Robertson RJ: Prescribing exercise in multiple short bouts versus one continuous bout: Effects on adherence, cardiorespiratory fitness, and weight loss in overweight women. Int J Obes Relat Metab Disord 19: , Johnson CA: Self-Esteem Comes in All Sizes: How to Be Happy and Healthy at Your Natural Weight. New York, Doubleday, Kayman S, Bruvold W, Stem JS: Maintenance and relapse after weight loss in women: Behavioral aspects. Am J Clin Nutr 52:80&807, Klem ML, Wing RR, McGuire MT, et al: A descriptive study of individuals successful at long-term maintenance of substantial weight loss. Am J Clin Nutr 66: , Lean MEJ: Sibutramine-a review of clinical efficacy. Int J Obes Relat Metab Disord 21:30%36S, Maddox GL, Liederman VR: Overweight as a social disability with medical implications. J Med Edu 44: , Miura J, Arai K, Ohno M, et al: The long term effectiveness of combined therapy by behavior modification and very low calorie diet: 2 year follow-up. Int J Obes Relat Metab Disord 13:73-77, National Heart, Lung, and Blood Institute: Clinical Guidelines on the Identification,

20 460 WADDEN & FOSTER Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report. Obes Res 6:51S-210S, National Task Force on the Prevention and Treatment of Obesity: Very low calorie diets. JAMA 270: , National Task Force on the Prevention and Treatment of Obesity: Long-term pharmacotherapy in the management of obesity. JAMA 276: , NHLBI Obesity Education Initiative Expert Panel: Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: The evidence report. Obes Res 6:51S-209S, Perri MG, Martin AD, Leermakers EA, et al: Effects of group- versus home-based exercise training in healthy older men and women. J Consult Clin Psychol 65: , Perri MG, McAdoo WG, McAllister DA, et al: Enhancing the efficacy of behavior therapy for obesity: Effects of aerobic exercise and a multi component maintenance program. J Consult Clin Psychol 54:67&675, Perri MG, McAllister DA, Gange JJ, et al: Effects of four maintenance programs on the long-term management of obesity. J Consult Clin Psychol 56: , Perri MG, Nezu AM, Viegener BJ: Improving the Long-Term Management of Obesity: Theory Research and Clinical Guidelines. New York, John Wiley & Sons, Pi-Sunyer FX Medical hazards of obesity. Ann Intern Med 119: , Pi-Sunyer FX: Guidelines for the approval and use of obesity drugs. Obes Res 3: , Price JH, Desmond SM, Krol RA, et al: Family practice physicians beliefs, attitudes and practices regarding obesity. Am J Prev Med 3: , Pronk NP: Physical activity and long-term maintenance of weight loss. Obes Res 2~ , Rand CSW, MacGregor AMC: Morbidly obese patients perceptions of social discrimination before and after surgery for obesity. South Med J 83: , Ravussin E, Lillioja S, howler WC, et al: Reduced rate of energy expenditure as a risk factor for body weight gain. N Engl J Med 318:462468, Sjostrom L, Rissanen A, Andersen T, et al: Randomized placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. Lancet , Spitzer RL, Yanovski SZ, Wadden TA, et al: Binge eating disorder: Its further validation in a multisite study. Int J Eat Disord 13: , Stunkard A: Talking with patients. In Stunkard AJ, Wadden TA (eds): Obesity: Theory and Therapy, ed 2. New York, Raven Press, Stunkard AJ, Harris JR, Pederson NL, et al: The body-mass index of twins who have been reared apart. N Engl J Med 322: , Stunkard AJ, Sobal J: Psychosocial consequences of obesity. In Brownell KD, Fairburn CG (eds): Eating Disorders and Obesity. New York, Guilford Press, 1995, pp Torgerson JS, Lissner L, Lindross AK, et al: VLCD plus dietary and behavioral support versus support alone in the treatment of severe obesity: A randomised two-year clinical trial. Int J Obes Relat Metab Disord , Viegener BJ, Perri MG, Nezu AM, et al: Effect of an intermittent, low-fat, low-calorie diet in the behavioral treatment of obesity. Behav Ther 21: , Wadden TA: Characteristics of successful weight loss maintainers. In Allison DB, Pi- Suyner FX (eds): Obesity Treatment: Establishing Goals, Improving Outcomes, and Reviewing the Research Agenda. New York, Plenum Press, 1995, pp Wadden TA: New goals of obesity treatment: A healthier weight and other ideals. Prim Psychiatry 5:45-54, Wadden TA, Bartlett SJ: Very-low-calorie diets: An overview and appraisal. In Wadden TA, Van Itallie TB (eds): Treatment of the Seriously Obese Patient. New York, Guilford Press, 1992, pp Wadden TA, Berkowitz RI: Behavior therapy and behavior therapy for obesity: A winning combination. Weight Control Digest 8: , Wadden TA, Berkowitz RA, Vogt RA, et al: Lifestyle modification in the pharmacologic

21 BEHAVIORAL TREATMENT OF OBESITY 461 treatment of obesity: A pilot investigation of a primary care approach. Obes Res , Wadden TA, Foster GD, Letizia KA: One-year behavioral treatment of obesity: Comparison of moderate and severe caloric restriction and the effects of weight maintenance therapy. J Consult Clin Psychol , Wadden TA, Letizia KA: Predictors of attrition and weight loss in persons treated by moderate and severe caloric restriction. In Wadden TA, VanItallie TB (eds): Treatment of the Seriously Obese Patient. New York, Guilford Press, 1992, pp Wadden TA, Sarwer DB: Behavioral treatment of obesity: New approaches to an old disorder. In Goldstein D (ed): The Management of Eating Disorders. Totowa, NJ, Humana Press, 1999, pp Wadden TA, Sternberg JA, Letizia KA, et al: Treatment of obesity by very low calorie diet, behavior therapy, and their combination: A five-year perspective. Int J Obes Relat Metab Disord 13:39-46, Wadden TA, Stunkard AJ: A controlled trial of very-low-calorie diet, behavior therapy, and their combination in the treatment of obesity. J Consult Clin Psychol 4: , Wadden TA, Vogt RA, Anderson RE, et al: Exercise in the treatment of obesity: Effects of four interventions on body composition, resting energy expenditure, appetite and mood. J Consult Clin Psychol 65: , Wadden TA, Vogt RA, Foster GD, et al: Exercise and the maintenance of weight loss: 1-year follow-up of a controlled clinical trial. J Consult Clin Psychol 66: , Wadden TA, Wingate BJ: Compassionate treatment of the obese individual. In Brownell KD, Fairbum CG (eds): Eating Disorders and Obesity, A Comprehensive Handbook. New York, Guilford Press, 1995, pp Weintraub M, Sundaresan PR, Madan M, et al: Long-term weight control study I (weeks 0 to 34). Clin Pharmacol Ther 51: , Weintraub M, Sundaresan PR, Schuster B, et al: Long-term weight control study 111 (weeks 104 to 156). Clin Pharmacol Ther 51:602407, Wing R, Blair EH, Marcus MD, et al: Year-long weight loss treatment for obese patients with Type I1 diabetes: Does inclusion of an intermittent very low calorie diet improve outcome? Am J Med , Wing RR: Behavioral approaches to the treatment of obesity. In Bray GA, Bouchard C, James WPT (eds): Handbook of Obesity. New York, Marcel Dekker, 1998, pp Wing RR, Blair EH, Marcus MD, et al: Year-long weight loss treatment for obese patients with type 2 diabetes: Does including an intermittent very-low-calorie diet improve outcome? Am J Med , Wing RR, Marcus MD, Salata R, et al: Effects of a very-low-calorie diet on long-term glycemic control in obese type 2 diabetic subjects. Arch Intern Med , Wing RR, Venditti EM, Jakicic JM, et al: Lifestyle intervention in overweight individuals with a family history of diabetes. Diabetes Care 21: , World Health Organization: Obesity: Preventing and Managing the Global Epidemic. Geneva, World Health Organization, Yanovski SZ: Binge eating disorder: Current knowledge and future directions. Obes Res 1: , 1993 Address reprint requests to Thomas A. Wadden, PhD University of Pennsylvania 3600 Market Street, Suite 738 Philadelphia, PA waddenqmail.med.upenn.edu

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