3
Programs for and Approaches to Treating Obesity

The wide variety of weight-loss interventions can be placed along a continuum on the basis of many factors, including intensity of treatment, cost, nature of the intervention(s), and degree of involvement of health-care providers. So numerous are the options from which a person wishing to lose weight can choose that we consider them here only in summary form, illustrating three major categories of programs:

  • Do-it-yourself programs

  • Nonclinical programs

  • Clinical programs

This grouping is not meant to imply that one should progress from one category to the next (i.e., one with a higher level of treatment intensity) if weight loss was not successful or only somewhat so. The next treatment option to try depends on the individual's state of health, the amount of weight to lose, his or her evaluation of the need for outside help, and other considerations.

The first part of this chapter consists of brief descriptions of do-it-yourself, nonclinical, and clinical programs. Following this, we discuss the broad approaches to treating obesity used within each of these categories of programs. These approaches include diet, physical activity, behavior modification, drug therapy, and gastric surgery.



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Weighing the Options: Criteria for Evaluating Weight-Management Programs 3 Programs for and Approaches to Treating Obesity The wide variety of weight-loss interventions can be placed along a continuum on the basis of many factors, including intensity of treatment, cost, nature of the intervention(s), and degree of involvement of health-care providers. So numerous are the options from which a person wishing to lose weight can choose that we consider them here only in summary form, illustrating three major categories of programs: Do-it-yourself programs Nonclinical programs Clinical programs This grouping is not meant to imply that one should progress from one category to the next (i.e., one with a higher level of treatment intensity) if weight loss was not successful or only somewhat so. The next treatment option to try depends on the individual's state of health, the amount of weight to lose, his or her evaluation of the need for outside help, and other considerations. The first part of this chapter consists of brief descriptions of do-it-yourself, nonclinical, and clinical programs. Following this, we discuss the broad approaches to treating obesity used within each of these categories of programs. These approaches include diet, physical activity, behavior modification, drug therapy, and gastric surgery.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs TYPES OF WEIGHT-LOSS PROGRAMS Do-It-Yourself Programs Do-it-yourself programs are individually formulated and therefore extraordinarily varied. This category includes any effort by an individual to lose weight by himself or herself or with a group of like-minded others, through programs such as Overeaters Anonymous and TOPS (Take Off Pounds Sensibly) or community-based and work-site programs. Individual judgment, books, products, and group therapy may dispense good or bad advice. The common denominator of programs in this category is that outside resources are not used in a personalized or individualized manner. We have identified five general subcategories of self-help programs: One subcategory includes the individual who is losing weight with a personally formulated low-calorie program with or without exercise, regardless of the safety or other characteristics of this effort. A second subcategory involves those who derive guidance from popular published materials such as books or magazines with diet instructions. A third subcategory includes those who use any of a number of popularly promoted products such as diet aids, low-calorie foods, and meal replacements. A fourth subcategory includes those who participate in a group as a source of counseling, advice, structure, or reinforcement. The fifth subcategory includes those participating in community-based and work-site programs. Nonclinical Programs Nonclinical programs are popular and are often commercially franchised. They typically have a structure created by a parent company and often use instructional and guidance materials that are prepared in consultation with health-care providers. The qualifying characteristic of these programs is that they rely substantially on variably trained counselors (who are not health-care providers by our definition) to provide services to the individual client. However, these programs are often managed or advised by qualified and licensed health-care providers. They may or may not sell prepared food products, meal replacements, or other products to their clients. Many popular weight-loss centers offer advice on nutrition, physical activity, and behavior modification, which is provided at weekly classes or meetings. Specific outcomes of any of these programs are unknown, since little or no published data are available (Stunkard, 1992).

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Clinical Programs In clinical programs, services are provided by a licensed professional who may or may not have received special training to treat obese patients. The programs may or may not be a part of a commercial franchise system. There are two subgroups within this category. One is the program in which an individual professional provider is working alone. It is assumed that, although the provider has the ability to refer the patient for special consultation, the services are in fact provided by the individual professional (psychologist, dietitian, physician, etc.) who is the focus of the therapeutic effort. The service provider may be providing such services as a very-low-calorie (formula) diet or medications. The other subcategory is a program that includes a multidisciplinary group of professional providers working together and systematically coordinating their efforts, records, and patient base. Their efforts may include such services as nutrition, medical care, behavior therapy, exercise, and psychological counseling, and they may utilize very-low-calorie diets, medications, and surgery. For the most part, specific outcomes of these individual programs are unknown. We have provided characteristics of specific, well-known weight-loss programs in Table 3-1. We adapted and expanded this table, originally presented in Ward (1994), using materials and comments supplied by most of the programs described. The reader should not misconstrue this information as an endorsement or rejection by us of any of these programs. It was not the intent of this report to evaluate specific programs. TABLE 3-1 A Comparison of Popular Weight-Loss Programs DO-IT-YOURSELF PROGRAMS Overeaters Anonymous (OA) Approach/Method Nonprofit international organization that provides volunteer support groups worldwide patterned after the 12-step Alcoholics Anonymous program. Addresses physical, emotional, and spiritual recovery aspects of compulsive overeating. Members encouraged to seek professional help for individualized diet/nutrition plan and for any emotional or physical problems. Clients Individuals who define themselves as compulsive eaters.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Staff Nonprofessional volunteer group members who meet specific criteria lead meetings, sit on the board, and conduct activities. Expected Weight Loss/Length of Program Makes no claims for weight loss. Unlimited length. Cost Self-supporting with member contributions and sales of publications (includes workbooks, tapes, newsletters, and sponsor outreach programs. Its international monthly journal, Lifeline, costs $12.99/year. Healthy Lifestyle Components Recommends emotional, spiritual, and physical recovery changes. Makes no exercise or food recommendations. Comments Inexpensive. Provides group support. No need to follow a specific diet plan to participate. Minimal organization at the group level, so groups vary in approach. No health-care providers on staff. Availability 10,500 groups in 47 countries. Headquarters: Rio Rancho, NM (505) 891-2664. TOPS (Take Off Pounds Sensibly) Approach/Method Nonprofit support organization of 310,000 members who meet weekly in groups. Does not prescribe or endorse particular eating or exercise regimen. Mandatory weigh-in at weekly meetings. Provides peer support. Uses award programs for healthy lifestyle changes; special recognition given to best weight losers. Members who maintain their goal weight loss for 3 months become members of KOPS (Keep Off Pounds Sensibly). Clients Members must submit weight goals and diets obtained from a health professional in writing. Staff Each group elects a volunteer (non-health professional) to direct and organize activities

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Weighing the Options: Criteria for Evaluating Weight-Management Programs for one year. Health professionals, including R.D.s and psychologists, may be invited to speak at weekly meetings. Organization consults with a medical advisor. Expected Weight Loss/Length of Program No claims made for weight loss. Unlimited length. Cost First visit free. $16 annual fee ($20 in Canada) for the first 2 years; $14 annually thereafter ($18 in Canada). Includes 40-page quarterly magazine from company headquarters. Weekly meetings cost 50 cents to $1. Healthy Lifestyle Components No official lifestyle or exercise recommendations, but endorses slow, permanent lifestyle changes. Members encouraged to consult health-care provider for an exercise regimen to meet their needs. Comments Inexpensive form of continuing group support. Used as adjunct to professional care. Nonprofit and noncommercial, so no purchases required. Encourages long-term participation. Lacks professional guidance at chapter level since meetings run by volunteers. Groups vary widely in approach. Availability 11,700 chapters in 20 countries, mostly U.S. and Canada. Headquarters: Milwaukee, WI (800) 932-8677. NONCLINICAL PROGRAMS Diet Center Approach/Method Focuses on achieving healthy body composition through diet and personalized exercise recommendations under the name Exclusively You Weight Management Program. Diet based on regular supermarket food; Diet Center prepackaged cuisine is optional. Body-fat analysis via electrical impedance taken at start of program and every 4 to 6 weeks thereafter. Clients encouraged to visit center daily for weigh-in. Calorie levels individualized to meet client needs and goals. Minimum level: 1,200 kcal/day. Four phases: 2-day conditioning phase prepares dieter for reducing. Reducing phase used until goal achieved. Stabilization, the third phase, has clients adjusting calories and physical activity to maintain weight. Maintenance, the fourth phase, lasts for 1 year. One-to-one counseling. Some group meetings available.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Clients Not allowed to join: pregnant, lactating, anorectic, bulimic, and underweight individuals, and those under 18 years of age. Require physician's written approval: those with more than 50 pounds to lose, kidney or heart disease, diabetes, cancer, or emphysema. Staff Clients consult with nonprofessional counselors who typically are program graduates trained by Diet Center. Two staff R.D.s and scientific advisors made up of a variety of health professionals design program at corporate level. Expected Weight Loss/Length of Program Not more than 1.5 to 2 pounds weekly. Length will vary with individualized client goals, but 1-year maintenance program strongly encouraged. Cost Varies. Ranges from about $35 to $50/week. The 1-year maintenance is a one-time flat fee ranging from $50 to $200. Some centers charge additional one-time fee for all body composition analyses and adjustments in diet and exercise goals. Healthy Lifestyle Components Exclusively Me behavior management, as an ongoing part of the program, includes an activity book, audio tapes, and counseling. Used in conjunction with regular one-to-one sessions; counselor helps client design personal solutions to weight-control problems. Comments Emphasizes body composition, not pounds, as a measure of health. Does not require the purchase of Diet Center food for participation. Professional guidance lacking at the client level. Little group support available. Vitamin supplement required. Availability 700 centers in U.S., Canada, Bermuda, Guam, and South America. Headquarters: Pittsburgh, PA (800) 333-2581. Jenny Craig Approach/Method Personal Weight Management menu plans based on Jenny Craig's cuisine with additional store-bought foods. Diet ranges from 1,000 to 2,600 kcal, depending on client needs. Mandatory weekly one-to-one counseling; group workshops. After clients lose half their goal, they begin planning their own meals using their own foods.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Clients Not allowed to join: individuals who are underweight, pregnant, or those below age 13; those with celiac disease, diabetes (who inject more than twice daily or who are under 18 years of age), or allergies to ubiquitous ingredients in company's food products. Require physician's written permission: individuals with 18 additional conditions. Regardless of condition, clients encouraged to communicate with personal physician throughout program. Staff Program developed by corporate R.D.s and psychologists. Company consults with advisory board of M.D.s, R.D.s, and Ph.D.s on program design. Consultants trained by Jenny Craig to implement program and offer support and motivational strategies. Corporate dietitians available for client questions or concerns at no extra charge. Expected Weight Loss/Length of Program Clients encouraged to set reasonable weight goals based on personal history and healthy weight standards. Program designed to produce weight loss of 1 to 2 pounds/week. A separate, 12-month maintenance program is also offered. Cost To join: $99 to $299, depending on option. Prices vary per inclusion of home audio-and videocassettes. Most expensive price includes Lifestyle Maintenance program. Jenny Craig cuisine costs average $70 weekly. Healthy Lifestyle Components Clients use program guides to learn cognitive behavioral techniques for relapse prevention and problem management for lifestyle changes. Based on individual priorities, clients address major factors involved with weight management (e.g., exercise, which is addressed through a physical activity module and a walking program). Individual consultations; group workshops provide motivation and peer exchange. The Lifestyle Maintenance program addresses issues such as body image and maintaining motivation to exercise. Comments Little food preparation. Vegetarian and kosher meal plans available; also plans for diabetic, hypoglycemic, and breastfeeding clients. Recipes provided. Must rely on Jenny Craig cuisine for participation. Lack of professional guidance at client level. Availability 800 centers in five countries; 650 centers in U.S. Headquarters: Del Mar, CA (800) 94-JENNY.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Nutri/System Approach/Method Menu plans based on Nutri/System's prepared meals with additional grocery foods. Clients receive individual calorie levels ranging from 1,000 to 2,200 kcal/day. Multivitamin-mineral supplement available for clients. Personal counseling and group sessions available. Clients Not allowed to join: individuals who are pregnant, under 14 years of age, underweight, or anorectic. Require physician's written permission: lactating women and those with a variety of conditions including diabetes (if require insulin shots), heart disease (that limits normal activity), and kidney disease. Staff Staff dietitians, health educators, and Ph.D.s develop program at corporate level. Scientific Advisory Board consisting of M.D.s and Ph.D.s employed for program design. Counselors with education and experience in psychology, nutrition, counseling, and health-related fields provide weekly guidance to clients. Certified Personal Trainers administer the Personal Trainer Program developed in conjunction with Johnson & Johnson Advanced Behavioral Technologies, Inc. R.D.s available through a toll-free number to address client questions. Expected Weight Loss/Length of Program Averages 1.5 to 2 pounds/week. Clients select weight goal based on a recommended weight range using standard tables. Program length varies with weight-loss goals. Cost Varies. Clients can lose all desired weight for $99. Unlimited service program costs $249. Food costs average $49/week. Vitamin-mineral supplements, at-home cholesterol test, motivational audiotapes, and exercise audio/videocassettes available at additional cost. Healthy Lifestyle Components Wellness and Personal Trainer services developed in conjunction with Johnson & Johnson Health Management have been added to the program. Comments Few decisions about what to eat; relatively rigid diet with company foods. Portion-controlled Nutri/System foods allow dieters to focus more on making lifestyle changes than on the reducing diet. Program provides both Wellness and Personal Trainer services. Little contact with health professionals.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Availability 650 centers in U.S. and Canada. Headquarters: Horsham, PA (215) 442-5411. Weight Watchers Approach/Method Emphasis on portion control and healthy lifestyle habits. Dieters choose from regular supermarket food, Weight Watchers Personal Cuisine (available in select markets to members only), or both. Reducing phase: Women average 1,250 kcal daily; men, 1,600 daily. Levels for weight maintenance determined individually. Weekly group meetings with mandatory weigh-in. Must need to lose at least 5 pounds to join. Clients Not allowed to join: those not weighing at least 5 pounds above the lowest end of their healthy weight range and those with a medically diagnosed eating disorder. Require physician's written approval: pregnant and lactating women and children under 10 years of age. Staff Group leaders are non-health professional graduates of program (Lifetime Members) trained by Weight Watchers. Program developed by corporate R.D.s. Company consults with medical advisor and advisory board consisting of M.D.s and Ph.D.s on program design. Health professionals at corporate level, including R.D.s, direct program. Expected Weight Loss/Length of Program Up to 2 pounds weekly. Unlimited length. Special 2-week Superstart program offers more rapid initial weight loss. Maintenance plan is 6 weeks. Cost $17–$20 to join; $10–$13 weekly. Fee entitles member to unlimited meetings for that week. Monthly meetings are free for Lifetime Members who have completed maintenance plan and maintain their weight goal within 2 pounds. Personal Cuisine prices vary, averaging about $70 weekly. Healthy Lifestyle Components Emphasizes making positive lifestyle changes, including regular exercise. Encourages daily minimum physical activity level. Comments Flexible program offering group support and well-balanced diet. Vegetarian plan available, plus healthy eating plans for pregnant and breastfeeding women. Encourages

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Weighing the Options: Criteria for Evaluating Weight-Management Programs long-term participation for members to attain their weight-loss goals. Lacks professional guidance at client level. No personalized counseling except in select markets. Availability 29,000 weekly meetings in 24 countries. Headquarters: Jericho, NY (516) 939-0400. CLINICAL PROGRAMS Health Management Resources (HMR) Approach/Method Medically supervised very-low-calorie diet (VLCD) of fortified, high-protein liquid meal replacements (520 to 800 kcal daily) or a low-calorie option consisting of liquid supplements and prepackaged HMR entrees (800 to 1,300 kcal daily). Dieters receive HMR Risk Factor Profile that measures and displays an individual's medical and lifestyle health risks. Mandatory weekly 90-minute group meetings. Maintenance meetings are 1 hour per week. One-to-one counseling. Need to have BMI >30 for VLCD. Clients Contraindications: pregnancy, lactation, and acute substance abuse. Require physician's written approval: some with acute psychiatric disorders, recent heart disease, cancer, renal or liver disease, insulin-dependent diabetes mellitus, and those who test positive for acquired immunodeficiency syndrome (AIDS). Staff Program developed by M.D.s, R.D.s, R.N.s, and psychologists. Each location has at least one M.D. and health educator on staff. Participants assigned ''personal coaches" (R.D.s, exercise physiologists, health educators) who help dieters learn and practice weight-management skills. Dieters on VLCD see M.D. or R.N. weekly. Expected Weight Loss/Length of Program Averages 2 to 5 pounds weekly. Reducing phase varies according to weight-loss needs, but averages 12 weeks; refeeding phase (after liquids only) lasts about 6 weeks. Maintenance program recommended for up to 18 months. Cost Varies depending on diet chosen and medical conditions. Ranges from $80 to $130/week including medical visits. Cost may be covered by insurance. Maintenance is $60–$90/month. Healthy Lifestyle Components Recommends every client burn a minimum of 2,000 kcal in physical activity weekly.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Advocates consuming a diet with no more than 30 percent of calories from fat and at least 35 servings of fruits and vegetables per week. Emphasizes lifestyle issues in weekly classes and in personal coaching. Comments Emphasizes exercise as a means for weight loss and control. Few decisions about what to eat. Supervised by a health professional. Requires a strong commitment to physical activity. Side effects of VLCD may include intolerance to cold, constipation, dizziness, dry skin, and headaches. All options include liquid supplement; diet is very high in protein, even at higher calorie levels. Availability 180 hospitals and medical settings nationwide. Headquarters: Boston, MA (617) 357-9876. Medifast Approach/Method Medifast is a physician-supervised very-low-calorie diet program of fortified meal replacements containing 450-500 kcal/day. LifeStyles—The Medifast Program of Patient Support® prepares patients to maintain their goal weight after completing the VLCD. Medifast also provides a low-calorie diet of approximately 860 kcal/day for those not indicated for the VLCD. Clients Contraindications: those who are not at least 30 percent above ideal body weight, those who have not reached sexual and physical maturation, pregnant and lactating women, those with a history of cerebrovascular accident, and those with conditions such as anorexia nervosa, bulimia, recent myocardial infarction, unstable angina, insulin-dependent diabetes, thrombophlebitis, active cancer, and uncompensated renal or hepatic disease. Staff Program supervised by a physician. At the corporate level, a medical advisory board of M.D.s, Ph.D.s, and R.D.s is consulted on program development. Expected Weight Loss/Length of Program Physician and patient arrive at an individualized goal weight. Metropolitan Life Insurance Company tables, Dietary Guidelines for Americans, and BMI charts used as guides. Weight loss varies with individual; average weight loss is 3–5 pounds/week. Weight Reduction Phase lasts 16 weeks and Realimentation Phase lasts 4–6 weeks. Maintenance strongly encouraged for up to 1 year.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Staff Individual physicians possibly working with associates (e.g., nurses and physicians' assistants). Provision of services by licensed professional health-care providers. Expected Weight Loss/Length of Program Varies with patient. Program may be of indefinite length and should be coordinated with care of related or unrelated medical issues. Cost Varies. Fees will be comparable to those charged for comparable medical services. Cost may be reduced by reimbursement from health-insurance companies and avoidance of duplication of services in referrals for medical care by nonprofessional programs. Healthy Lifestyle Components Varies with the physician and weight-loss approach. Should include exercise and nutrition counseling. Comments Professional care. Coordination with other medical problems. Appropriate for patients with complex or serious associated medical problems. Long-term attention in the context of other medical care can be provided. The potential for using medications and/or surgery expands the opportunities for patients at varying stages of their disease. Individual physicians have the ability to vary the patient's care and intensity of the effort depending on the patient's life circumstances. Physicians often inadequately trained in nutrition and in low-calorie physiology. Cost for services can be high. Availability Generally available, but many physicians are reluctant to treat obesity because of their lack of interest or training, recognition that support services that they cannot provide are needed, and concern for the limited usefulness of their intervention.   SOURCE: Ward, 1994. Copyright 1994 by Environmental Nutrition, Inc., 52 Riverside Drive, New York, NY 10024-6599. Adapted and expanded with permission. Descriptions reviewed by organizations for accuracy.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs APPROACHES TO TREATMENT We have identified five broad approaches to treatment used by the do-it-yourself, nonclinical, and clinical programs: diet, physical activity, behavior modification, drug therapy, and gastric surgery. Not all approaches are used by, or available to, each category of programs. However, each program category uses one or more of these approaches. Diets Balanced-Deficit Diets Balanced-deficit diets provide 1,200 or more kcal/day and are usually nutritionally adequate, providing at least the minimum recommended number of servings from all major food groups. Many published diet books outline balanced-deficit diets, although not all are sensible (Dwyer and Lu, 1993). Balanced-deficit diets require little, if any, medical supervision except, for example, under circumstances in which the diet or resulting weight loss might alter a person's underlying medical condition and result in the need for management. Low-Calorie Diets Low-calorie diets provide approximately 800–1,200 kcal/day. Some of these diets utilize regular foods, while others are designed to use specially formulated or fortified products and prepackaged foods. A typical low-calorie diet is designed to provide no more than 25 percent of calories as fat, but many find it difficult to achieve and maintain such a low-fat intake. A low-calorie diet utilizing only regular foods may require vitamin-mineral supplementation to meet the nutritional needs of the client. Commercial low-calorie diet programs include Weight Watchers, Diet Workshop, Diet Center, Jenny Craig, and Nutri/System, all of which are based on the use of regular foods, prepackaged foods (which may be optional or required), and/or dietary supplements from the company. (These programs may provide balanced-deficit diets as well.) All of these programs use a multidisciplinary approach with combined diet, exercise, and behavior change. Many low-calorie diets are also self-administered. Some over-the-counter diet products include Sweet Success (Nestlé) and Slim Fast. These diet products are specially formulated powders or foods designed as meal replacements. Weight loss with low-calorie diets averages approximately 0.5 to 1.5 kg/week (8.5 kg over 20 weeks) (NTF, 1993). Other low-calorie diets described in books range from low-fat, high-carbohydrate diets to

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Weighing the Options: Criteria for Evaluating Weight-Management Programs nutritionally unbalanced diets void of any scientific basis (Dwyer and Lu, 1993). Low-calorie diets are safe for patients who have comorbid conditions such as diabetes, hyperlipidemia, or hypertension. However, they should be followed only with physician approval and supervision by a health-care provider since the patient may become ketotic and dehydrated, especially if the diet is very low in carbohydrate (Dwyer and Lu, 1993). In addition, patients on medication (e.g., oral glucose-lowering agents) may require changes in their medication schedule or amount because of energy restriction and weight loss. The overwhelming majority of participants on low-calorie diets regain their weight lost within 5 years (NIH Technology Assessment Conference Panel, 1993), and the attrition rate in commercial programs is very high (e.g., more than 60 percent over 20 weeks) (Stunkard, 1992). Very-Low-Calorie Diets Very-low-calorie diets (VLCDs) are modified fasts providing less than 800 kcal/day, and they replace usual food. Most VLCD programs are based in hospitals or clinics and include the commercial programs Opti-fast, Medifast, New Direction, and Health Management Resources (HMR) (Dwyer and Lu, 1993). They are medically supervised and administered by a multidisciplinary team including physicians, behavioral therapists, dietitians, exercise physiologists, and nurses. The most common VLCDs are formulations designed to supply 45–100 grams (0.8–1.5 g/kg of ideal body weight) per day of protein of high biological value (coming primarily from dairy sources, soy, or albumin); up to 100 grams of carbohydrate; a minimum of fat as essential fatty acids; and recommended allowances of vitamins, minerals, and electrolytes (NTF, 1993). VLCDs are generally limited to moderately and severely obese individuals with a body mass index (BMI) of greater than 30 who have failed to lose weight by more conventional methods, but they may be appropriate for patients with a BMI of 27 to 30 who have a comorbid condition. Designed to generate a larger and more rapid weight loss than low-calorie diets, they are usually prescribed for 12 to 16 weeks (NTF, 1993). VLCDs have rapid, positive effects on the health of obese patients with comorbid conditions (Kanders and Blackburn, 1993). Improvements in glycemic control, decreases in systolic and diastolic blood pressure, and decreases in serum concentrations of total cholesterol, low-density-lipoprotein cholesterol, and triglycerides occur within 3 weeks. In controlled clinical trials, VLCDs resulted in an average total loss of 20 kg over 12 weeks. In contrast, low-calorie diets combined with behavioral treatment produced an average loss of 8.5 kg over 20 to 24 weeks.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs However, the vast majority of patients on VLCDs regain the weight within 5 years (Miura et al., 1989; Sikand et al., 1988; Wadden et al., 1989; Wing et al., 1991a). VLCDs are quite expensive compared to low-calorie diets; out-of-pocket expenses can exceed $3,500 for the diet itself, medical evaluation and monitoring, individual counseling, and group classes. Physical Activity Although most of the do-it-yourself, nonclinical, and clinical programs mention physical activity, it frequently appears to be an afterthought, rather than an integral part of the intervention. Physical activity ranges in intensity from walking to vigorous activities, such as jogging and bicycling. The more vigorous the activity, the more the body's energy stores are utilized. Each individual should develop a realistic goal for increasing activity, starting with a low level that feels comfortable and progressing slowly to higher levels. One key to maintaining an increased level of physical activity is finding the kinds of activities that engage one's interests and can be fit into one's lifestyle and constraints on time. There are few studies of recidivism associated with exercise, though recidivism appears to be high (Dishman, 1988, 1991; Foreyt and Goodrick, 1994). Obesity treatment programs should include a systematically planned and integrated physical activity intervention in order to develop a lifestyle change associated with increased physical activity and thus energy expenditure. Behavior Modification Behavior modification is a methodology aimed at helping individuals identify the idiosyncratic problems and barriers interfering with their weight loss and management. Specific behavioral principles are used to solve these problems. No obesity-treatment program can afford to ignore this treatment approach. The principles used in behavior modification typically include self-monitoring, stimulus control, contingency management, stress management, cognitive behavioral strategies, and social support. Self-monitoring consists of two steps: self-observation and self-recording of those observations. Food and exercise diaries are used to assess the client's eating habits and activity levels. Stimulus control involves identifying the environmental cues associated with unhealthy eating and under-exercising. Modifying the cues often involves strategies such as limiting eating to specific times and places, buying food when not hungry, and laying out exercise clothing to encourage a regular habit of physical activity. Contingency management includes the use of rewards for appropriate

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Weighing the Options: Criteria for Evaluating Weight-Management Programs behavior changes, such as reducing grams of fat in the diet and increasing minutes of daily exercise. Stress management involves the use of problem-solving strategies to reduce or cope with stressful events. Meditation, relaxation procedures, and regular exercise are examples of stress-reducing techniques. Cognitive-behavioral strategies are used to help change a client's attitudes and beliefs about unrealistic expectations, appropriate goals, and body image. Examples include the use of affirmations (positive self-statements) and visual imagery (seeing oneself eating and exercising appropriately). The principles and techniques are tailored to each person's specific problems. Social support, usually from the family or a group, is used to maintain motivation and provide reinforcement for appropriate behavior changes. All behavioral principles are used to help individuals adhere to a healthy diet and exercise program. Drug Therapy There is increased interest in the use of medications to treat obesity, given the recent consensus that obesity is a chronic disease with biological and genetic bases that is affected by an environment promoting physical inactivity and consumption of energy-dense foods (Bouchard et al., 1990; Stunkard, 1990) (see Table 3-2). In reviews of short-term (< months), double-blind, placebo-controlled trials with 7,725 subjects, pharmacologic agents resulted in an average weight loss of 0.23 kg/week compared to placebo (Galloway et al., 1984; Goldstein and Potvin, 1994; Scoville, 1973). In a review of 27 weight-reduction studies reported between 1967 and March 1992, Goldstein and Potvin (1994) examined the effect of drug therapy of at least 6 months' duration on weight loss and maintenance. The studies reviewed used a variety of agents, including dexfenfluramine, fluoxetine, mazindol, phentermine, and varied experimental designs. In those subjects who responded to drug therapy, weight loss leveled off after approximately 6 months. Goldstein and Potvin recommend that future research focus on identifying subgroups of individuals who are responsive and unresponsive to specific drugs. If one compares obesity to other chronic diseases such as hypertension and non-insulin-dependent diabetes mellitus, obesity treatments should also include the option of using medication for periods longer than 6 months. However, few studies have investigated this option. In three studies, d-fenfluramine was studied for 52 weeks (Guy-Grand et al., 1989), fluoxetine for 52 weeks (Darga et al., 1991; Marcus et al., 1990), and the combination of phentermine and d,l-fenfluramine for 3.5 years (Weintraub et al., 1992a). In these studies, drugs helped to maintain lower body weight in a significant number of subjects without intolerable adverse

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Weighing the Options: Criteria for Evaluating Weight-Management Programs TABLE 3-2 Appetite-Suppressing Drugs Noradrenergic Agents DEAa Schedule Trade Name Half-Life (hours) Dosage Size (mg) Daily Dose Range (mg) Benzphetamine III Didrex 6–12 25; 50 25–150 Phendimetrazine III Anorex; Obalan; Phendiet; Plegine; Wehless; and others 5–12 35 70–210 Diethylpropion IV Tenuate; Tepanol 4–6 25; 75 (slow release) 75 Mazindol IV Mazanor; Sanorex 10 1 or 2 1–3 Phentermine IV Fastin; Ionamin; Phentrol; Adipex-P; and others 12–24 8; 15; 30 15–37.5 Phenylpropanolamine Over the counter Dexatrim 7–24 25 or 75 25–75 Serotonergic agents Fenfluramine (d- or d-l) IV Pondimin 11–30 20 60–120 Fluoxetine Not scheduled Prozac; Lovan 24–72 20; 60 60 a DEA = Drug Enforcement Agency. See box titled ''Unreasonable Standards for Anti-Obesity Drugs?" for an explanation of the schedule classification. SOURCE: Reproduced with permission, from G.A. Bray. Use and abuse of appetite-suppressant drugs in the treatment of obesity. Ann. Intern. Med. 1993;119:707–713.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs UNREASONABLE STANDARDS FOR ANTI-OBESITY DRUGS? Do the standards used to evaluate drugs for the treatment of obesity differ from those applied to drugs to treat other chronic diseases? A drug for treating hypertension, for example, is considered efficacious if blood pressure decreases when the drug is taken. The drug is not required to continue to lower blood pressure further as therapy continues, nor is the patient judged to have failed when blood pressure increases after the medication is withdrawn. This is also the case for drugs used to treat diabetes, asthma, and schizophrenia or to lower blood cholesterol concentrations. For any specific drug, however, a patient may or may not respond in the desired manner. In sharp contrast to antihypertensives and lipid-lowering drugs, anti-obesity drugs are expected to work for most obese patients independent of the etiology of the disease. Furthermore, there is an expectation that drugs will continue to lower body weight until a desirable weight is reached and will maintain the weight loss even after the drug is discontinued (Atkinson and Hubbard, 1994). One example of this expectation is the fact that medical practice review boards and/or state regulations in nearly all states prohibit prescribing anti-obesity drugs for longer than 3 months (personal communication, Richard L. Atkinson, M.D., Professor of Medicine and Nutritional Sciences, University of Wisconsin, Madison). These circumstances suggest that a double standard exists for the use of anti-obesity drugs. We suggest that these drugs be judged effective if they can produce small but medically significant weight losses and be used for maintenance of weight loss. After evaluating the views of Pi-Sunyer and Campfield (personal communications at committee workshop, December 1993), we believe that anti-obesity drugs should be considered effective when their use in combination with a sound program of diet and exercise results in (1) achievement of weight loss of at least 5 percent of initial body weight and maintenance of that loss; (2) reduced body weight through a reduction of body fat with a sparing of body protein; (3) reduction of comorbidities; and (4) minimum or tolerable side effects and low abuse potential. It should be noted that patients most appropriate for drug therapy include those with comorbidities (e.g., hypertension, hyperglycemia, dyslipidemias, and sleep apnea) that can be diminished with weight loss and those at high risk for obesity-related comorbidities. We recommend that the U.S. Food and Drug Administration (FDA), which must approve all prescription drugs, focus on the pathogenesis of obesity as a chronic disease and evaluate drugs for its treatment in that light. Drugs either approved or in development for treating obesity may decrease energy intake (e.g., serotonin uptake inhibitors, peptide-based appetite suppressants), increase energy expenditure or thermogenesis (e.g., beta-adrenergic receptor agonists), stimulate lipolysis (e.g., alpha-adrenergic receptor antagonists), or decrease fat or other macronutrient absorption (e.g., pancreatic lipase inhibitors) (Bray, 1993c; Goldstein and Potvin, 1994). A question arises as to why this country has lagged so far behind other countries in the approval and use of anti-obesity drugs. In the United States, no new drugs have been approved for the treatment of obesity since 1972 (Atkinson and Hubbard, 1994). For example, d-fenfluramine, approved in Europe and much of

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Weighing the Options: Criteria for Evaluating Weight-Management Programs the rest of the world for some years, is still pending approval in this country. Furthermore, fluoxetine, approved in this country to treat depression and obsessive-compulsive disorder, has been under consideration by FDA for the treatment of obesity for more than 6 years (personal communication, Richard L. Atkinson, M.D.). Some of the barriers include a common view shared by the lay public, health-care providers, and government administrators that obesity is not a disease (Atkinson and Hubbard, 1994). Atkinson and Hubbard (1994) note that "obesity drugs are held to higher standards than drugs used for other diseases. Although it is generally agreed that obesity is a chronic disease, obesity drugs are limited to short-term use, no longer than a few weeks. Physicians who prescribe obesity drugs for longer periods are subject to scrutiny by State Medical Review Boards and may face loss of licensure." In contrast to current medical practice, Stallone and Stunkard (1992) have proposed that appetite-suppressant medication be used on a long-term basis or not at all. Research on anti-obesity drugs has been hindered by fears of the abuse potential of these medications and previous indiscriminate prescription of these drugs by some physicians (Atkinson and Hubbard, 1994). This is also reflected in the Drug Enforcement Agency's classification of anti-obesity drugs. Schedule II drugs have a high abuse potential, Schedule III some abuse potential, and Schedule IV low abuse potential. The initial appetite-suppressant drugs (amphetamine, meth-amphetamine, and phenmetrazine), appropriately classified as Schedule II, are no longer in use. Other drugs in use, with little evidence of abuse potential, are still classified so that they are recommended for no more than a few weeks (personal communication, F. Xavier Pi-Sunyer, Chief, Division of Endocrinology, Diabetes, and Nutrition at St. Luke's/Roosevelt Hospital Center, New York City). In three major studies of longer-term drug therapy (Darga et al., 1991; Marcus et al., 1990; Weintraub et al., 1992a, b), drugs helped some subjects maintain lower weights, and there is some indication the drugs may help change behavior. According to the work of Weintraub et al. (1992a, b), a combination of two types of drugs may be more effective for long-term weight loss and weight maintenance than either used alone. Because of regulation, use of medications is limited to the short term, no longer than a few weeks (Atkinson and Hubbard, 1994). Some physicians, however, may prescribe such drugs "off label," meaning not approved by FDA, for longer periods of time. effects compared to controls. When medication was discontinued, weight was regained, and when medication was reintroduced, there was additional weight loss (Weintraub et al., 1992b). Not all individuals responded to drug treatment. As with other chronic diseases, it is unrealistic to expect that one therapeutic drug would be effective for all individuals. Weintraub (1994) suggests that the standard crossover design in evaluating the effectiveness of a weight-management drug, in which subjects initially receive the drug and others the placebo and then at some point are switched to the other modality, is not appropriate. Subjects do not return to their baseline state before starting the next treatment. Weintraub believes that some of the variability in response to drug treatment can be

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Weighing the Options: Criteria for Evaluating Weight-Management Programs reduced by a 3- to 6-week "run-in" period during which subjects are started on ancillary therapy, including calorie restriction, behavior modification, and exercise. One can then assess the degree of commitment of the subjects and their response to the ancillary therapy prior to drug treatment. Drug treatment is then added to the ancillary therapy. Weintraub encourages use of this approach when treating obese patients with drugs for weight management. A National Institutes of Health workshop on the pharmacological treatment of obesity concluded that "obesity drugs produce short-term weight loss and may remain effective for extended periods of time in some patients" (Atkinson and Hubbard, 1994). Nevertheless, drugs should be used as only one component of a comprehensive weight-reduction program that includes attention to diet, activity, and behavior modification. According to Silverstone (1993), these drugs should be limited to patients who are medically at risk because of their condition, among which he includes those with a BMI of 30 or greater or those with a comorbid condition. Gastric Surgery Because of its unique nature, the special requirements of participating patients, and the characteristics of the services implied in this type of program, the surgical treatment of obesity is a special subcategory of clinical programs. Two proven surgical procedures exist for the treatment of severe and very severe obesity: vertical banded gastroplasty and Roux-en-Y gastric bypass. Vertical banded gastroplasty consists of constructing a small pouch with a restricted outlet along the lesser curvature of the stomach. Roux-en-Y gastric bypass involves constructing a proximal gastric pouch whose outlet is a Y-shaped limb of small bowel of varying lengths (NIH, 1992). Vertical banded gastroplasty is less complex to perform and has fewer perioperative complications than gastric bypass, but produces less long-term weight loss (Sugerman et al., 1989). On the other hand, a higher risk of nutritional deficiencies exists following gastric bypass (NIH, 1992). Intestinal bypass surgery is no longer recommended as a surgical option to treat obesity (NIH, 1992). The risk-benefit ratio must be evaluated for each patient when deciding if surgery should be utilized. Patients who have failed with nonsurgical measures and who are well informed and motivated may be considered. They must be able to participate in treatment and long-term follow-up. A BMI greater than 40 indicates the patient may be a potential candidate for surgical treatment (NIH, 1992). Patients with a BMI between 35 and 40 may be considered if they have high-risk comorbid conditions such as life-threatening cardiopulmonary problems or severe diabetes

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Weighing the Options: Criteria for Evaluating Weight-Management Programs mellitus (NIH, 1992). Obesity-induced physical problems that interfere with lifestyle, for example, joint disease treatable but for obesity, may also be an indication for surgery for patients with a BMI between 35 and 40 (NIH, 1992). Substantial weight loss generally occurs within 12 months of the operation, with some of the weight being regained within 2 to 5 years. With weight loss comes improvement in the comorbid conditions that often accompany obesity. The risks associated with the surgical treatment of obesity include postoperative complications, micronutrient deficiencies, "dumping syndrome," and late postoperative depression (NIH, 1992). There is compelling evidence that comorbidities are reduced in severely obese patients who have lost weight as a result of gastric surgery. Therefore, it is puzzling that this treatment is not more widely used for severely obese individuals at very high risk for obesity-related morbidity and mortality. It is possible that health-care providers and individuals alike fail to fully understand the severity and costs of obesity in terms of both increased morbidity and mortality and its impact on the quality of life. Perhaps there is also an intrinsic fear of the dangers of surgery due in part to lack of knowledge. In fact, mortality associated with gastric surgery for obesity is less than 1 percent (Kral, 1992). It has been proposed that most of the complications associated with this type of surgery, unlike most other surgery, are modifiable by behavior. For example, Kral (1994) notes that the vomiting seen in approximately 10 percent of patients after surgery is due more to eating behavior than to stenosis or stricture of the gastroplasty stoma. Another reason for the limited use of gastric surgery for obesity is that it is not always reimbursable (Chase, 1994). In the Swedish Obesity Study, patients in the surgical intervention group reported marked improvements in health, mood, and obesity-specific problems compared to controls (Näslund, 1994). This same study estimated that 7 percent of the costs to the work force of lost productivity due to sick leave and disability pension are related to obesity. Obesity surgery would profit from cost-benefit analyses that include the social and psychological benefits that many experience from the procedure. Weight-loss surgery clearly involves hospital care. Any surgical program should be supported by appropriate nutritional, medical, and psychological counseling for the long-term management of the patients enrolled, although some programs of this kind in fact have no such support systems. CONCLUDING REMARKS This chapter has provided an overview of the many weight-loss programs, which are organized for convenience into three major categories,

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Weighing the Options: Criteria for Evaluating Weight-Management Programs and the five broad approaches to treatment used by them. In most cases, do-it-yourself, nonclinical, and clinical programs may be appropriate for people at any level of overweight, and some are also applicable for people who are not overweight but who want to obtain information and learn skills to keep from developing a weight problem. Anti-obesity drugs produce short-term weight loss and may remain effective for extended periods, so regulatory policies at the state and federal levels may need to be modified to permit use of these agents by appropriate individuals for longer periods of time than often allowed at present. Surgery is an option only for individuals whose BMI exceeds 40 or for those with a BMI of 35–40 suffering from high-risk comorbid conditions. Recommended programs will almost always include a focus on improving diet, increasing physical activity, and modifying behaviors that lead to weight gain. In the following section of this report, Chapters 4 through 8, we present a conceptual overview of decisionmaking and use it to develop criteria and a model for evaluating obesity-treatment programs. The Weighing the Options model presented in Chapter 8 provides a framework for the conduct of programs that should help consumers choose more wisely from among available programs and be more successful at long-term weight loss.