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Introduction and Background

In spite of our ever-increasing knowledge of the health risks of obesity, people in the United States are getting fatter. This country is in the midst of an epidemic of obesity, as described in Chapter 2, with 35 percent of women and 31 percent of men aged 20 and older considered obese. The prevalence is even higher among those with lower levels of education, black women, and Mexican-Americans of both sexes.

Many individuals want to lose weight for a variety of reasons that include improving appearance, feeling better, and being healthier. Often a person's primary motivation for weight loss is to increase his or her perceived attractiveness and self-esteem. Health-care providers are most likely to recommend weight loss to help obese people decrease their risks of developing, and improve the management of, a variety of medical problems and chronic diseases that includes diabetes, hypertension, other cardiovascular diseases, sleep apnea, and osteoarthritis of weight-bearing joints.

It is paradoxical that obesity is increasing in the United States while more people are dieting than ever before, spending, by one estimate, more than $33 billion per year on weight-reduction products (including diet foods and soft drinks, artificial sweeteners, and diet books) and services (e.g., fitness clubs and weight-loss programs) (U.S. Congress, 1990). The majority of dieters have designed their own weight-loss programs (95 percent of men and 87 percent of women, according to one survey [Levy and Heaton, 1993]), which may be based on popular books, include over-the-counter diet aids, and consist of self-directed modifications



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Weighing the Options: Criteria for Evaluating Weight-Management Programs 1 Introduction and Background In spite of our ever-increasing knowledge of the health risks of obesity, people in the United States are getting fatter. This country is in the midst of an epidemic of obesity, as described in Chapter 2, with 35 percent of women and 31 percent of men aged 20 and older considered obese. The prevalence is even higher among those with lower levels of education, black women, and Mexican-Americans of both sexes. Many individuals want to lose weight for a variety of reasons that include improving appearance, feeling better, and being healthier. Often a person's primary motivation for weight loss is to increase his or her perceived attractiveness and self-esteem. Health-care providers are most likely to recommend weight loss to help obese people decrease their risks of developing, and improve the management of, a variety of medical problems and chronic diseases that includes diabetes, hypertension, other cardiovascular diseases, sleep apnea, and osteoarthritis of weight-bearing joints. It is paradoxical that obesity is increasing in the United States while more people are dieting than ever before, spending, by one estimate, more than $33 billion per year on weight-reduction products (including diet foods and soft drinks, artificial sweeteners, and diet books) and services (e.g., fitness clubs and weight-loss programs) (U.S. Congress, 1990). The majority of dieters have designed their own weight-loss programs (95 percent of men and 87 percent of women, according to one survey [Levy and Heaton, 1993]), which may be based on popular books, include over-the-counter diet aids, and consist of self-directed modifications

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Weighing the Options: Criteria for Evaluating Weight-Management Programs of diet and exercise. Despite efforts to improve the efficacy of treatments for obesity, no methods have emerged that offer a substantial chance of long-term weight loss except for surgery among the extremely obese. The fact is that despite the billions of dollars spent, few people reduce their body weight to a desirable or healthy level and even fewer maintain the weight lost beyond 2 or 3 years. Chapter 3 describes the abundance of weight-control services, programs, and products currently available, which range from popular books and over-the-counter diet aids to medically supervised weight-management programs, drugs, and surgery. For practical purposes, we have grouped the options into three major categories of programs: do-it-yourself, nonclinical, and clinical programs. We also identify and describe five broad approaches to treatment used by these programs: diet, physical activity, behavior modification, drug therapy, and gastric surgery. The related Appendixes A and B provide examples of assessment instruments that might be used in obesity treatment in clinical and research settings. Chapter 4 presents a simple conceptual overview of the factors relevant to decisionmaking, in this case, by a person making decisions about weight loss. It consists of the individual's choosing one or more weight-loss programs, undertaking the program, and experiencing the outcome of the undertaking. Three criteria were developed to be used by individuals in evaluating weight-loss programs: (1) the match between the program and consumer, (2) the soundness and safety of the program, and (3) outcomes of the program. Together, these criteria provide guidance for consumers to increase their chances of success at weight loss and for weight-loss programs to increase their ability to help individuals lose weight. Criterion 1, the subject of Chapter 5, pertains to the match between the individual and the program (i.e., trying to predict, with some degree of precision, which individuals will succeed in a given program). We describe many factors that influence the program choices of individuals and review a number of matching schemes proposed by others. Chapter 6 addresses Criterion 2, the soundness and safety of the program. A sound weight-loss program should give attention to diet and physical activity, be as safe as reasonably possible, and encourage clients to have some knowledge of their weight-related physical health and psychological status. Chapter 7 presents Criterion 3, the outcomes of the program. Here we identify the psychological and physiological factors associated with long-term success at weight loss. This chapter also presents a new concept of obesity treatment focused on the achievement or maintenance of health rather than on simple weight reduction. The concept is based on the scientific literature documenting that obese individuals do not need

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Weighing the Options: Criteria for Evaluating Weight-Management Programs to lose all or even most of their excess weight in order to improve risk factors (e.g., blood pressure and blood cholesterol and glucose concentrations) and, presumably, their health. Therefore, a primary goal of weight-loss programs in the future should be to help people lose enough weight to reduce the health risks associated with obesity rather than achieve a culturally defined ideal or desirable body weight. In effect, we are recommending that weight-loss programs evolve into weight-management programs. Chapter 8 synthesizes the criteria presented in Chapters 4–7 in the form of a model. Our Weighing the Options model can be used by an individual wishing to lose weight, ideally with the help of a health-care provider, to learn the legitimate options available, identify weight-management goals, and reevaluate goals and options on the basis of results obtained from specific programs. We hope our criteria and model will serve several purposes: (1) enable outside parties to evaluate programs in a consistent and comprehensive fashion, (2) stimulate programs to disclose important information to consumers as a matter of policy and to improve the quality of the programs, and (3) help consumers make informed choices in program selection with a focus on long-term weight management rather than simple weight loss. The chapter presents a framework for the conduct of weight-management programs so that they can be evaluated more uniformly and consumers can make informed choices. Current understanding in the treatment of obesity has led to questioning traditional beliefs about long-term weight management (i.e., the maintenance of weight loss)—particularly the view that successful weight loss requires a period of intense management that can be followed by much less attention during the maintenance phase. To the extent that powerful biological and environmental forces are at work to regain lost weight, weight can be kept down only by dealing with obesity as one would manage any chronic disease—by continuous treatment, lifelong efforts, and vigilance. We use the term weight management in this report to refer to weight loss over both the short term (the period of actual weight loss) and the long term (the long, indefinite period of effort aimed at minimizing the amount and rate of regain of lost weight). Successful weight management ultimately includes preventing obesity from developing in the first place. Chapter 9 focuses on the prevention of new cases of this disease at three levels by targeting (1) the general population, (2) high-risk subgroups, and (3) individuals who are overweight but not yet obese or who are otherwise known to be predisposed to obesity. Unfortunately, work-site- and community-based prevention programs have produced results no better than those of obesity treatment

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Weighing the Options: Criteria for Evaluating Weight-Management Programs programs. Hopes had been high that these low-cost programs, which have attracted large numbers of individuals, would be effective. The most optimistic feature of this report is surely found in the research agenda in Chapter 10. Learning more about how health-related behaviors develop and can be modified, together with the rapid growth of knowledge and better tools in areas such as molecular genetics and metabolic regulation, gives promise that at some point we will understand the underlying causes of obesity. This should ultimately lead to the development of programs that treat the underlying causes of obesity and not just the symptoms. INFLUENCING THE PRACTICES OF WEIGHT-LOSS COMPANIES Our charge was to develop criteria for evaluating weight-loss programs, and this is the focus of the middle and main section of our report. We began our efforts by reviewing earlier and ongoing efforts to influence and regulate the practices and advertising claims of the weight-loss industry. Specifically, we reviewed criteria for weight-loss programs established by the New York City Department of Consumer Affairs (Winner, 1991) and the Michigan Task Force to Establish Weight Loss Guidelines (Drewnowski, 1990); actions by the Federal Trade Commission to regulate deceptive claims by weight-loss programs (see, for example, Clark, 1993a, b); and guidelines from the National Institutes of Health (NIH) for evaluating weight-loss methods and programs (NIH Technology Assessment Conference Panel, 1993) and for choosing a weight-loss program (NIDDK, 1993a). We also considered an accreditation system for weight-management programs (see Appendix D). These important examples of efforts to influence or regulate the activities of the weight-loss industry do not imply any endorsement on our part, though they helped us in various ways in developing our recommendations throughout this report. Within the scientific community, there are varying opinions about the correctness and appropriateness of some of the statements and recommendations contained in these examples. New York City Department of Consumer Affairs (DCA) The DCA first documented some of the deceptive practices used by rapid-weight-loss centers by having DCA staff, posing as potential clients, visit 14 weight-loss centers. Staff members reported that (1) the vast

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Weighing the Options: Criteria for Evaluating Weight-Management Programs majority of centers did not discuss potential risks even when asked, (2) some centers counseled underweight individuals to lose weight, and (3) some centers made false and misleading statements going beyond scientific evidence and engaged in quackery (Winner, 1991). As a result of this 1991 investigation, the DCA put into effect the nation's first "Truth-in-Dieting" regulation on May 17, 1992. The ruling applies to more than 130 weight-loss centers in New York City that promote rapid weight loss. Rapid weight loss, using the DCA criteria, referred to "weight loss of more than 1 1/2 pounds to 2 pounds per week or weight loss of more than 1 percent of body weight per week after the second week of participation in a weight-loss program." The requirements of the four-step ruling included (1) posting of a "Weight-Loss Consumer Bill of Rights" sign; (2) handing the potential client a "palm-size" copy of the sign; (3) disclosing all the costs of the program, including those associated with purchase of products or laboratory tests; and (4) disclosing the duration of the recommended program (Winner, 1991). The required "Bill of Rights'' sign was to state: WARNING: Rapid weight loss may cause serious health problems. (Rapid weight loss is weight loss of more than 1 1/2 to 2 pounds per week or weight loss of more than 1 percent of body weight per week after the second week of participation in a weight-loss program.) Only permanent lifestyle changes—such as making healthful food choices and increasing physical activity—promote long-term weight loss. Consult your personal physician before starting any weight-loss program. Qualifications of this provider's staff are available on request. You have a right to ask questions about the potential health risks of this program, its nutritional content, and its psychological-support and educational components; know the price of treatment, including the price of extra products, services, supplements, and laboratory tests; and know the program duration that is being recommended for you. Although it is not required, at least one commercial program has been distributing the Bill of Rights sign to clients outside the New York City area (personal communication with Linda Webb Carilli, M.S., R.D., General Manager, Corporate Affairs, Weight Watchers International, Inc.).

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Michigan Department of Public Health In 1990, a task force appointed by the Michigan Department of Public Health developed a set of guidelines for adult weight-loss programs in that state (Drewnowski, 1990; Petersmarck, 1992). The guidelines, listed in Table 1-1, apply to nonclinical and clinical programs and are quite TABLE 1-1 Weight-Loss Guidelines for Michigan, 1990 Screening The client should be screened to verify that there are no medical or psychological conditions which could make weight loss inappropriate. The client's level of health risk should be identified: low-risk, moderate-risk, or high-risk. Level of Care The weight-loss program should provide the level of care appropriate to the client's level of health risk: Levels of Care 1, 2, or 3. Individualized Treatment Plan Factors contributing to the client's weight status should be identified. These factors should serve as the bases for each client's individualized weight-loss plan, which may include the weight goal, and plans for nutrition, exercise, behavioral change, medical monitoring or supervision, and health supervision. Staffing Weight-loss service providers should be trained and supervised adequately for the level of health risk of clients receiving care. Full Disclosure The client should give informed consent, having been informed of potential physical and psychological risks from weight loss and regain, likely long-term success of the program, full cost of the program, and credentials of the weight-loss care providers. Reasonable Weight Goal The weight goal for the client should be based on personal and family weight history, not exclusively on height and weight charts. Rate of Weight Loss The advertised and actual rate of weight loss, after the first two weeks, should not exceed an average of two pounds per week. Calories per Day The daily caloric level should be adjusted so that each client can achieve but not exceed the recommended rate of weight loss. The daily caloric intake should not be lower than 1,000 calories at Level 1; 800 calories at Level 2; and 600 calories at Level 3. If the daily caloric level is below 800 calories, additional safeguards should be in place.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Diet Composition • Protein: between 0.8 and 1.5 grams of protein per kilogram of goal body weight, but no more than 100 grams of protein per day. • Fat: 10–30 percent of calories as fat. • Carbohydrate: at least 100 grams per day for Level 1; at least 50 grams per day for Level 2. • Fluid: at least one quart of water daily. Nutritional Adequacy The food plan should allow the client to obtain 100 percent of the client's Recommended Dietary Allowances (RDA). If nutrition supplements are used, nutrient levels should not greatly exceed 100 percent of the RDA. Nutrition Education Nutrition education encouraging permanent healthful eating patterns should be incorporated into the weight-loss program. Formula Products The food plan should consist of a variety of foods available from the conventional food supply. Formula products are not recommended for the treatment of moderate obesity, and should not be used at low-calorie formulations without specialized medical supervision. Exercise Component The weight-loss program should include an exercise component that is safe and appropriate for the individual client: • The client should be screened for conditions which would make medical clearance before exercise appropriate. • The client should be instructed to recognize and deal with potentially dangerous physical responses to exercise. • The client should work toward 30–60 minutes of continuous exercise 5–7 times per week, with gradual increases in intensity and duration. Psychological Component Behavior modification techniques appropriate for the specific client should be taught. Appetite Suppressants Appetite suppressant drugs are not recommended, and should not take the place of changes in diet, exercise, and behavior. Weight Maintenance A maintenance phase should be included in the treatment program.   SOURCE: Drewnowski, 1990. Reprinted with permission.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs detailed. They have the advantage of screening prospective clients to assess their level of health risk and, on that basis, recommending individualized, multidisciplinary approaches that include nutrition, exercise, and behavior modification. The Michigan guidelines attempt to forge a match between program and client that is dictated by the client's health needs. It was the hope of the task force that its guidelines would be adopted as standards of health care in weight-loss programs throughout Michigan. Adoption of the guidelines would mandate that potential clients be screened for health risks prior to beginning a calorie-restricted diet and that weight-loss programs and clinics be staffed by qualified professionals capable of delivering appropriate levels of health care. Federal Trade Commission In contrast to guidelines aimed at defining essential components of programs, the Federal Trade Commission's (FTC) efforts address and challenge specific, allegedly deceptive advertising claims that companies have made to promote their weight-reduction programs and diet aids. The FTC actions seek to place the companies under an order designed to remedy those allegedly deceptive claims. By the end of December 1993, the FTC had either begun litigation or settled complaints it had issued against 11 commercial weight-loss companies (personal communication with Richard F. Kelly, Esq., Assistant Director for the Division of Service Industry Practices, Federal Trade Commission). In each of the cases that have been settled through a consent agreement, the FTC's order requires that any statements made about "success of participants of any weight loss program in achieving or maintaining weight loss or weight control" be based on data representative of either all participants or a clearly-defined subset of participants (personal communication with Richard F. Kelly, Esq.). When a claim is made that participants in a program successfully maintain lost weight, the order requires in most instances that the claim be accompanied by a disclosure of data that reflects the actual experience of program participants and a general statement about the temporary nature of most weight loss. An example given by FTC of "acceptable disclosure" is: "participants maintain an average of 60% of weight loss 22 months after active weight loss (includes 18 months on maintenance program). For many dieters weight loss is temporary" (FTC, 1993). NIH Guidelines for Evaluating Weight-Loss Programs The NIH Technology Assessment Conference on methods for voluntary

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Weighing the Options: Criteria for Evaluating Weight-Management Programs weight loss and control provided guidelines for evaluating weight-loss methods and programs (NIH Technology Assessment Conference Panel, 1993). According to the guidelines, information about program success that should be obtained includes the following: the percentage of all beginning participants who complete the program; the percentage of those completing the program who achieve various degrees of weight loss; the proportion of weight loss that is maintained at 1, 3, and even 5 years; and the percentage of participants who experienced adverse medical or psychological effects and the kind and severity. Valid and reliable statistics of this kind are important, but they are not routinely provided by commercial diet plans or programs. Such data, preferably in the form of peer-reviewed published studies, should be available for all supervised programs, including those based in hospitals, clinics, or private practice. According to the guidelines, additional information on program characteristics that should be obtained includes the relative mix of diet, exercise, and behavior modifications; the amount and kind of counseling: both individual counseling and closed groups (membership does not change except by attrition) are more successful than open groups (in which members may come and go); the nature of available multidisciplinary expertise (including medical, nutritional, psychological, physiologic, and exercise); the training provided for relapse prevention to deal with high-risk emotional and social situations; the nature and duration of the maintenance phase; and the flexibility of food choices and suitability of food types, and whether weight goals are set unilaterally or cooperatively with the program director. NIH Guidelines for Choosing a Weight-Loss Program The Obesity Task Force at the National Institutes of Health developed consumer guidelines for choosing a safe and successful weight-loss program (NIDDK, 1993a). The five program features include the following:

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Weighing the Options: Criteria for Evaluating Weight-Management Programs The diet should be safe and include all of the Recommended Dietary Allowances for vitamins, minerals, and protein. The program should be directed towards a slow, steady weight loss unless a more rapid weight loss is medically indicated. A doctor should evaluate health status if the client's weight-loss goal is greater than 15–20 pounds, if the client has any health problems, or if the client takes medication on a regular basis. The program should include plans for weight maintenance. The program should give the prospective client a detailed list of fees and costs of additional items. CONCLUDING REMARKS In this country, where successful weight management has proven an elusive goal for most obese individuals, the marketplace has provided many legitimate, as well as unfounded, products and services. The latter play legal tag with governmental regulatory agencies while taking financial advantage of a public desperate for answers. Improving the rate of success of weight management requires that would-be dieters understand that methods from thigh creams to esoteric diets must be substantiated by validated evidence of efficacy. They may represent no more than small countermeasures to an incompletely understood disorder of energy balance. In addition, obese individuals must learn to stay away from programs that give false hopes by suggesting that, compared to the programs of legitimate competitors, they are more effective at weight loss and that their unique methods ensure permanent loss. For its part, the scientific community must continue research that will provide us with a fundamental understanding of the basic causes of obesity; this understanding is essential if we are to design maximally effective obesity treatments and develop the means for preventing the disease.