8
Weighing the Options: Application of Committee's Criteria

Chapters 4 through 7 present and expand upon a decisionmaking framework to describe the thought processes of an individual embarking on and evaluating a weight-management program. This chapter summarizes that information in a model we call Weighing the Options (see Figure 8-1). It is a conceptual model of the decisionmaking process leading to treatment and outcome. Outcome, in turn, leads to evaluation or reevaluation of the choice of program, whereby one returns to the beginning of the model. It is our attempt to combine, in graphic form, consumer choice with program options and evaluations.

DERIVATION OF THE MODEL

The Weighing the Options model emphasizes implicitly that weight management for obese individuals requires a lifelong plan. It shows explicitly that the individual is at the center of decisionmaking, with input received from a variety of sources. A central feature of the model is that it broadens the definition of a successful outcome. The model emphasizes that weight management is a dynamic process in which both individuals and programs set and evaluate goals periodically and employ a variety of strategies for attaining these goals. It is meant to be used by both a program and an individual.

Our recommendations for evaluating weight-management outcomes (Criterion 3) include both specific (quantitative) and more general (qualitative) ones. We have identified common goals for all weight-management



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Weighing the Options: Criteria for Evaluating Weight-Management Programs 8 Weighing the Options: Application of Committee's Criteria Chapters 4 through 7 present and expand upon a decisionmaking framework to describe the thought processes of an individual embarking on and evaluating a weight-management program. This chapter summarizes that information in a model we call Weighing the Options (see Figure 8-1). It is a conceptual model of the decisionmaking process leading to treatment and outcome. Outcome, in turn, leads to evaluation or reevaluation of the choice of program, whereby one returns to the beginning of the model. It is our attempt to combine, in graphic form, consumer choice with program options and evaluations. DERIVATION OF THE MODEL The Weighing the Options model emphasizes implicitly that weight management for obese individuals requires a lifelong plan. It shows explicitly that the individual is at the center of decisionmaking, with input received from a variety of sources. A central feature of the model is that it broadens the definition of a successful outcome. The model emphasizes that weight management is a dynamic process in which both individuals and programs set and evaluate goals periodically and employ a variety of strategies for attaining these goals. It is meant to be used by both a program and an individual. Our recommendations for evaluating weight-management outcomes (Criterion 3) include both specific (quantitative) and more general (qualitative) ones. We have identified common goals for all weight-management

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Weighing the Options: Criteria for Evaluating Weight-Management Programs FIGURE 8-1

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Weighing the Options: Criteria for Evaluating Weight-Management Programs CHOOSING A WEIGHT-MANAGEMENT OPTION: AN ANALOGY Perhaps a helpful analogy to choosing a weight-management option is deciding how to approach financial planning. An individual may not want to have a financial plan, may have a variety of specific financial goals, or may wish simply to achieve financial security but have no strategy for doing so. He or she initiates the process by deciding what techniques to use to manage assets. An individual may choose to manage them personally with help from articles, books, or self-help groups; with others by joining an investment club or taking a class in financial planning; or by going to a professional for help. Two or more options might be combined. And, for some individuals, life circumstances force them to react to financial issues as they arise, when planning is not a realistic option. An individual meeting with a financial planner is often asked to complete a questionnaire that helps the planner to evaluate the client's assets, past history, and projected gain, and to identify appropriate long- and short-term goals. Since there is the implicit assumption that financial management also requires lifelong planning, some individuals work in partnership with financial planners, and goals are reviewed and redefined periodically as circumstances and income change. efforts. The means of evaluating these outcomes will vary depending on the type of program (do-it-yourself, nonclinical, or clinical) and the claims it makes for success. Three criteria, introduced in Chapter 4, are used to structure the evaluation of weight-management programs: Criterion 1, the match between the program and consumer; Criterion 2, the soundness and safety of the program; and Criterion 3, the outcomes of the program. The programs themselves are characterized as do-it-yourself, nonclinical, and clinical (see Chapter 3). The recommendations presented in the next section are both quantitative and qualitative, depending on the information base pertaining to each criterion, and may vary with the type of program. Generally, conservative treatments should be used for mildly obese individuals without comorbidities, whereas more aggressive treatments such as surgery should be reserved for those at high or very high risk. For example, a person with a body mass index (BMI) greater than 40 who has hypertension and has failed in attempts at weight loss might be a potential candidate for gastric surgery. Surgery would not be an option for an individual with a BMI of 28, even with obesity-related comorbidities. Readers should not interpret these remarks as an endorsement of a stepped-care approach to weight management. We do not, for example, recommend that individuals try a clinical program only after they fail at do-it-yourself or nonclinical programs. We are well aware that the recommendations in this chapter will

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Weighing the Options: Criteria for Evaluating Weight-Management Programs elicit a variety of reactions. Some will consider them to be overly general and not providing sufficiently detailed guidance to consumers for selecting a program and to programs for improving the quality of their services. Others will see the recommendations as being too prescriptive—too much like implicit standards of care that regulatory agencies or consumer-protection bodies at the national, state, or local levels might turn into regulations resulting in potentially onerous and expensive limitations on the conduct of major commercial weight-loss programs. We developed our recommendations without engaging in this debate and based them on the scientific research available and the deliberative judgment of the committee. As one expert committee, we think it likely that implementing the recommendations in this chapter will help more people to lose weight successfully, improve overall health, and keep off excess weight over the long term. How they are implemented, however, should be decided not by us but by broad constituencies through an interactive process of public discussion. Consumers, weight-management programs, and regulatory agencies should all find these recommendations of use in somewhat different ways. Our recommendations are meant to apply to the weight-management programs that use data or testimonials in their advertising and promotional activities to suggest that weight loss is likely to be successful with them or that they are more effective than competing programs. Programs that engage in these activities should be held to some level of proof of their contentions, so they must be encouraged to collect certain types of information in standardized ways and to provide certain kinds of information to potential clients. Potential clients, in turn, should be encouraged to expect this information from programs, so that programs that do not comply may be put at a competitive disadvantage and thereby become motivated to rethink their position. This information is needed so that consumers can make informed choices and there can be reasonable oversight of programs by regulatory agencies such as the Federal Trade Commission, the Food and Drug Administration, and state medical practice review boards, as well as by interested biomedical scientists. Weight-management programs that do not make claims of success—such as classes provided by a community YMCA or YWCA, counseling by dietitians at a local hospital, or meetings of a local chapter of Overeaters Anonymous—should not be required to assume the data-collection burdens and expense of meeting our recommendations, but should endeavor to do so if resources permit. Given that the loss of even a small amount of weight may benefit health, we want interested clients to have many options in their communities to receive help in achieving a healthful life-style. We are, as some critics would assert, singling out weight-loss programs

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Weighing the Options: Criteria for Evaluating Weight-Management Programs for special attention in contrast to, for example, smoking-cessation or alcohol treatment programs. We believe strongly that weight-loss programs require special attention. Unfortunately, our health-care system has not treated obesity as a chronic disease requiring long-term management, even as the prevalence of this disease continues to increase. We believe that a new concept of obesity treatment is needed, and this report represents a first effort by a group of multidisciplinary biomedical experts convened by the Food and Nutrition Board of the Institute of Medicine to stimulate this process. As detailed in Chapter 7, we have proposed expanding the concept of weight loss to include long-term weight management with the ultimate goal of improved health. This report provides clients, obesity-management programs, researchers, and policymakers with recommendations by which to evaluate programs and outcomes. Although there will undoubtedly be discussion about the specific details of our recommendations, we believe that consensus exists about the need for them. APPLICATION OF OUR CRITERIA This section describes our recommendations for satisfying the three criteria described in Chapters 4–7 and illustrated in Figure 8-1. Programs could use these criteria to enhance quality control; monitor adherence to national, state, or local regulations; and conduct research and market analyses (or permit them to be conducted by outside scientists) on their effectiveness. Individuals would use these criteria to help them select a program and to evaluate periodically whether the program meets their changing needs. Criterion 1: Match Between Program and Consumer Weight-loss programs attempt to meet consumer needs and desires, and consumers determine their goals for weight loss partly on the basis of program claims. In Chapter 5, we describe three sets of factors that influence an individual's choice of programs: (1) personal, situational, and global factors (e.g., age, gender, motivation, readiness to change, views about weight and appearance, and the cost and ready availability of a program); (2) health status and weight-related risk factors (e.g., presence or absence of hypertension, dyslipidemias, and diabetes and family history or other comorbidities); and (3) information and guidance (e.g., from family, friends, books, magazines, advertising, and health-care professionals). Consumers choose a program based on some combination of these factors. In Chapter 7, we identify factors most frequently linked

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Weighing the Options: Criteria for Evaluating Weight-Management Programs with success at weight loss and maintenance of that loss. These include a habit of regular exercise, continued contact with the treatment program, reasonable and nutritious eating patterns, continued self-monitoring of diet and exercise, a positive problem-solving attitude toward life's stressors, and positive changes in physiological factors that are often adversely affected by obesity. Given that the goal in matching consumers with programs is to maximize the chances of achieving long-term weight loss, it is unfortunate that the ability of consumers and health-care providers to make successful matches is limited at present. The complex interactions that occur between an individual and the many factors that influence program choice are beyond the current ability of biomedical science to explain, much less predict. Clearly, there is a need for future research to reduce the chances of mismatches. Nevertheless, it is possible to make some prudent qualitative recommendations to increase the likelihood of a successful match. Program's Perspective: Who Is Appropriate for This Program? Each program decides what types of clients are appropriate and inappropriate given its specific philosophies, protocols, and treatment approaches. Pregnant women and individuals who are underweight or anorectic are inappropriate candidates for any weight-loss program. Nonclinical programs should require (and do-it-yourself programs should advise) that lactating women, children, and adolescents, as well as those with bulimia; significant cardiovascular, renal, or psychiatric disease; diabetes; or other significant medical problems undertake weight loss only under medical supervision. Nonclinical programs should encourage clients with obesity-related comorbidities or other health problems to maintain contact with their health-care provider for the duration of the program. Both nonclinical and clinical programs should obtain some information on the state of health and weight-loss goals of potential clients to determine if they are appropriate for a specific program and what types of individualized attention they may require. Do-it-yourself programs such as those provided in diet books, diet plans in magazines, or over-the-counter weight-loss devices or products should provide information in the text or other instructional materials on who might and who should not use the program. Since there is usually no legal obligation that this information be provided or that it be true and complete, it is the responsibility of the publisher or manufacturer of the program to provide it voluntarily. In general, the lack of such information or the suggestion that the program is for anyone who wishes to

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Weighing the Options: Criteria for Evaluating Weight-Management Programs lose weight (no matter how much one desires or needs to lose or one's age, state of health, or stage of life) should arouse suspicion that the program might not be sound. Consumer's Perspective: Should I Be in This Program Given My Goals and Characteristics? Because consumers decide on their own or with the help of others (e.g., family, friends, or health-care providers) whether to enter a weight-loss program and which one to choose, they must consider carefully their weight-loss goals and whether they are appropriate candidates for weight loss, and decide whether the time is right for them to devote the considerable attention and effort required to succeed. It is important that consumers commit time and energy to losing weight and maintaining the weight loss; they will fail if they do not make sincere efforts, no matter how good the program. We believe that individuals should have the right to select the therapeutic modality they believe to be most suited to their needs or to select no treatment—although we hope they will seek guidance from health-care providers in making their decision. Some individuals may find treatment too onerous or otherwise unsuitable. In this case, they should expect that the provider will not withhold medical assistance required to treat any medical problems that might be related to their weight or hold them accountable for those problems. Individuals should expect a program to provide them with sufficient information to help assess whether they are appropriate or inappropriate potential candidates. We strongly recommend that those contemplating a do-it-yourself or nonclinical program be evaluated first by a health-care provider (or have been assessed in the recent past) before proceeding. They should discuss the program or product with their health-care provider to determine whether it is sound and appropriate. Individuals who are extremely obese (i.e., BMI >40) and have failed at attempts to lose weight should discuss with their health-care provider the risks they face and the options available to them, such as gastric surgery and medications. These two options should be used as appropriate with a program of diet, physical activity, and behavior modification. Criterion 2: Soundness and Safety of the Program Weight-management programs should be based on sound biological and behavioral principles and should be relatively safe for their intended

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Weighing the Options: Criteria for Evaluating Weight-Management Programs participants. Each of the following components is essential to address in applying the criterion. Health and Weight Status Healthy weights are generally associated with a BMI of 19–25 in those 19–34 years of age and 21–27 in those 35 years of age and older (USDA and DHHS, 1990). However, individuals with a BMI of 25–27 are at slight risk from obesity if they have no comorbidities and at moderate risk if they do (see Figure 2-6). Beyond these ranges, health risks increase as BMI increases. Health risks also increase with excess visceral fat (waist-to-hip ratio [WHR] >1.0 for males and >0.8 for females), high blood pressure (>140/90), dyslipidemias (total cholesterol and triglyceride concentrations of >200 and >225 mg/dl, respectively), non-insulin-dependent diabetes mellitus, and a family history of premature death due to cardiovascular disease (e.g., parent, grandparent, sibling, uncle, or aunt dying before age 50). Weight loss usually improves the management of obesity-related comorbidities or decreases the risks of their development. Psychological Status Psychological status can be assessed by using the tools listed in Appendix A. At this time, we recommend that prior to beginning a weight-management program, all individuals take the Dieting Readiness Test (discussed in Chapter 6 and presented in Appendix B) or some comparable test, which can be administered and scored by the individual or appropriate staff at a nonclinical program. Such a test helps to point out potential problems with motivation and attitudes toward dieting and exercise. Clinical programs should also administer the General Well-Being Schedule (also discussed in Chapter 6 and presented in Appendix B) or a comparable test to identify frank psychological pathologies (e.g., depression) and determine whether an individual should be referred for more in-depth psychological assessment before beginning the program. Diet Consumption of a calorically modified diet containing a variety of foods is required for long-term weight management in individuals with or tending toward obesity. For practical purposes, we define a good dietary pattern as one in which the individual meets the Food Guide Pyramid guidelines on at least 4 of 7 days. A few nonclinical but many clinical programs put their clients on diets that are based on the use of special nutritional products and dietary supplements; this is generally appropriate during the treatment phase but is often difficult to sustain for long periods of time. Decreasing total energy intake and the consumption of dietary fat, sugar, and alcohol, while providing adequate nutrients, dietary fiber, and protein to maintain nitrogen balance and limit the loss of lean body mass, is a time-tested way to lose weight safely.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs Although we do not prescribe a minimal level of energy intake for safe weight loss, clients should be made aware that energy intakes of less than 1,200 kcal/day will usually not meet nutrient requirements and that a vitamin-mineral supplement will be needed. Diets of less than 800 kcal/day should not be used except under a physician's supervision. Physical Activity Regular physical activity is also essential for long-term weight management because it helps to promote weight loss and decrease regain, reduce obesity-related risk factors, and decrease morbidity and mortality. For practical purposes, we define a minimal level of physical activity as the accumulation of one-half hour or more of moderate-intensity activity (such as brisk walking) four or more times a week. Safety All programs should be reasonably safe and pose minimal untoward health risks to clients. Risks vary by program. Generally, approaches that require oversight by physicians (e.g., use of drugs and surgery) or special diets that deviate substantially from healthy eating patterns, or are very low in energy content, pose the most risk. The nature of complications varies with the weight-loss method used. Diets that are not nutritionally adequate in protein, vitamins, minerals, and dietary fiber should be used only for compelling reasons—on a temporary basis and with appropriate supplementation—during the treatment phase of weight loss. Program's Perspective: Is My Program Based on Sound Biological and Behavioral Principles, and Is It Safe for Its Intended Participants? All providers should take steps to ensure that their programs are safe and sound. Nonclinical and clinical programs can provide information about the qualifications and training of staff as well as appropriate corporate managers and, if desired, consultants involved in developing the program. Authors and other originators of do-it-yourself programs should cite their credentials, qualifications, and experiences in managing obesity. Clinical programs should be able to assess the physical and psychological health of their patients. Nonclinical and do-it-yourself programs, in contrast, can only encourage clients to have such an assessment conducted by their health-care providers. All programs should encourage individuals to know their blood pressure and blood lipid concentrations; whether or not they have diabetes, osteoarthritis in weight-bearing joints, or sleep apnea; and whether a family member has died prematurely from coronary heart disease. Do-it-yourself and nonclinical programs should strongly encourage individuals who have one or more of these risk factors to be under the care of a health-care provider. These programs should

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Weighing the Options: Criteria for Evaluating Weight-Management Programs develop simple checklists for clients to highlight the importance of routinely monitoring health status. Clinical programs should assess all clients for these risk factors. Nonclinical and clinical programs should measure the height and weight of clients and calculate their BMI and WHR, providing both the results and the information to interpret those results. Do-it-yourself programs should encourage their clients to take these measurements and make these calculations, instruct them how to do so, and explain the results. Clients in nonclinical and clinical programs should have their diets and physical activity patterns evaluated at least at the beginning and end of the treatment phase of the program and every 6 months during any maintenance phase (see Appendix A for various assessment tools). Nonclinical programs should assess the psychological status of clients with the Dieting Readiness Test; clinical programs should use it along with the General Well-Being Schedule (see Appendix B; however, comparable assessment tools are appropriate). Do-it-yourself programs should inform clients about the importance of attention to diet, physical activity, and psychological assessment (by providing, for example, the Dieting Readiness Test), and give explicit guidance in how to do so (as discussed above and in earlier chapters). Since no weight-loss attempt is risk free, it is incumbent on each program to inform potential clients about the known and hypothetical risks of that program. Clinical programs have special responsibilities to assess and manage potential risks, especially when special diets (such as very-low-calorie diets), drugs, or surgery are used as part of the treatment. For example, if a diet is not nutritionally adequate, clients should be given or advised to take dietary supplements. Potential side effects of the dietary program and of specific drugs used for treating obesity should be explained, including the potential for drug-drug interactions. Patients considering gastric surgery should be counseled on the operative and perioperative surgical risks (NIH, 1992). Consumer's Perspective: Is the Program Safe and Sound for Me? Given the limitations of do-it-yourself and nonclinical programs to assess health compared to clinical programs, consumers choosing the former have a greater responsibility for self-monitoring their health. Consumers should have a good understanding of the program of interest and what they can expect from it throughout the treatment and any maintenance phase. They should have access to information about the qualifications and training of staff in nonclinical and clinical programs and the

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Weighing the Options: Criteria for Evaluating Weight-Management Programs credentials and qualifications of the author/originator of a do-it-yourself program. Clients should expect that the program of interest will be a safe and sound one (by meeting our recommendations for them as detailed above). We recommend that they monitor their weight weekly and continue to assess (or have assessed) their diet and physical activity patterns at 6-month intervals or more frequently after the weight-loss phase of a program. This will act as a useful periodic check on these two major influences of weight and will help to maintain weight loss. Criterion 3: Outcomes of the Program In Chapter 7, we recommend that weight-loss programs be judged by how well individuals do in four areas: (1) long-term weight loss, (2) improvement in obesity-related comorbidities, (3) improved health practices, and (4) monitoring of adverse effects that might result from the program. We note that potential clients should expect that a high-quality program will attend to, or urge attention be paid to (since most of these components are not under the direct control of the program), each of these areas. For practical purposes, we have developed qualitative and quantitative measures for each of these components of successful weight management (see box titled ''Measures of Successful Weight Management"). Achieving these outcomes is a joint responsibility of the program and the individual. A program, for example, can provide exemplary information and guidance on healthful eating, incorporating more activity into one's life, and enhancing self-esteem, but it is the individual's responsibility to put this into practice. Also, do-it-yourself and nonclinical programs can encourage an individual to be screened by a health-care provider, but they may not be able to provide such screening nor should they be expected to find a provider for someone without medical insurance. Program's Perspective: What Is the Evidence for Success of My Program? It is not cost effective or practical for most do-it-yourself programs to evaluate their outcomes. Nevertheless, they can make sure that they cover the importance of long-term weight loss and the reduction of obesity-related comorbidities, provide information and guidance on improving health behaviors, and discuss in detail the potential health risks from weight loss in general and their program in particular. Because clients come physically to nonclinical and clinical programs,

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Weighing the Options: Criteria for Evaluating Weight-Management Programs MEASURES OF SUCCESSFUL WEIGHT MANAGEMENT Long-Term Weight Loss Long term means 1 year or more, and weight loss of any significance is the loss of ≥ 5 percent of body weight or a reduction in BMI by 1 or more units. Improvement in Obesity-Related Comorbidities One or more associated risk factors (e.g., high blood pressure; elevated blood concentrations of cholesterol, triglycerides, or glucose; and non-insulin-dependent diabetes mellitus), if present, should be improved to a degree considered clinically significant. Improved Health Practices Obtaining health-related knowledge may be assessed indirectly by evaluating whether basic information about obesity is presented by the program and whether the individual reads or hears it. Engaging in good eating habits may be assessed by using a dietary assessment tool such as those cited in Appendix A or evidence that the individual meets the recommendations of the Food Guide Pyramid on at least 4 of 7 days. Engaging in regular physical activity involves one-half hour or more of moderate-intensity activity (such as brisk walking) four or more times a week and preferably daily. Obtaining regular medical attention includes seeing a physician at yearly intervals, particularly if the individual has not achieved a healthy weight. Regular screening of these individuals by a health-care provider will help to identify as early as possible the presence of comorbid conditions and lead to the initiation or continuation of appropriate treatment. Improved well-being can be assessed through questionnaires described in Appendix A. For all programs, we recommend a test such as the Dieting Readiness Test and, in addition, for clinical programs only, the General Well-Being Schedule (see Appendix B). Monitoring of Adverse Effects That Might Result from Program Clinical and nonclinical programs should question their clients periodically about any changes in health while on the program and should encourage them to volunteer such information if changes do occur. A do-it-yourself program should inform consumers that because the program may potentially have adverse health effects, they should be attentive to any changes in their health while on it. the programs can monitor and document their weight loss over time. Such programs should have quality control procedures in place to ensure that protocols are adhered to by staff and to modify those protocols as warranted given the experiences and feedback of clients. They should also have mechanisms to evaluate the success of their programs. If the company is organized as a franchise, mechanisms should be available to evaluate the program as a whole and at individual sites. All programs should also provide information and guidance on improving health behaviors and should discuss the potential risks of dieting, including those from their programs. Do-it-yourself and nonclinical

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Weighing the Options: Criteria for Evaluating Weight-Management Programs programs should encourage clients (and strongly encourage those with obesity-related comorbidities) to have regular contact with a health-care provider throughout the treatment and maintenance phases of their weight loss so that their overall health can be monitored as well as the disposition of any comorbidities. Clinical programs should be expected to provide this medical assessment and monitoring. It is appropriate that weight-management programs continue to be judged primarily on their success in achieving long-term weight loss (including small weight losses that are maintained). However, in addition, programs should be judged on their ability to empower their clients to eat a healthful diet and become more active, reduce obesity-related comorbidities, improve the objective and subjective measures of their quality of life, and make desired changes in health-related knowledge and attitudes. Consumer's Perspective: Are the Benefits I Am Likely to Achieve from the Program Worth the Effort and Cost? When they begin a weight-management program, consumers must recognize that they and the program have responsibilities for the final outcome. To improve their chances for success, consumers should choose programs that focus on long-term weight management; provide instruction in healthful eating, increasing activity, and improving self-esteem; and explain thoroughly the potential health risks from weight loss. Individuals interested in a specific do-it-yourself program should search in the program literature for evidence that the program is successful; if information on success is absent or consists primarily of testimonials or other anecdotal evidence (including, in the case of programs by health-care providers, only their own clients or patients), the program should be viewed with suspicion. Consumers should look for programs that devote considerable effort to helping people change their behaviors through information, guidance, and skill training. To make the most of the weight-management effort, however, consumers should have realistic expectations of a program and be willing to devote the time and effort required. Those in do-it-yourself and nonclinical programs should be in touch with a health-care provider who can monitor the status of any obesity-related comorbidities and changes in health. When an individual chooses a program, it should be in light of his or her short- and long-term goals for weight management. Our Weighing the Options model (see Figure 8-1) is a dynamic one that incorporates periodic reevaluation by the client and program to assess whether an individual and a program are meeting these goals and whether the goals or

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Weighing the Options: Criteria for Evaluating Weight-Management Programs the treatment should be modified. We recommend these evaluations every 3 to 6 months. TRUTH AND FULL DISCLOSURE This section describes the nature and amount of information to be disclosed to individuals considering a weight-management program. Information on program disclosure should be sufficient to enable the client to make informed choices among the program options and, we hope, decrease unrealistic expectations. Our recommendations, if put into practice, should also lead to decreases in unsubstantiated claims and thus highlight unethical behavior by the programs themselves. The background for these recommendations is the extensive literature on informed voluntary consent that has become a key element in research on human subjects (Faden et al., 1986). This section builds on several sets of guidelines: those of the National Institutes of Health (NIH) Technology Assessment Conference Panel (1993) on methods for voluntary weight loss and control, the weight-loss guidelines for Michigan (Drewnowski, 1990; Petersmarck, 1992), the truth-in-dieting regulation in New York City (Winner, 1991), and rules developed by the Federal Trade Commission for use by commercial programs in making specific claims (see Chapter 1). Any weight-management program has a responsibility to prospective clients to provide truthful and unambiguous information that is not misleading or subject to misinterpretation. This includes a written (and, for nonclinical and clinical programs, oral) description of the risks and benefits of treatment and the opportunity to ask questions. To assist individuals in making informed choices from the many nonclinical and clinical programs, information made available should include the nature of a given program, its structure and management, and a description of its staff, including training; all costs, including effort and time; the type of client typically served by the program; and the short- and long-term treatment outcomes. Key elements of these recommendations are provided in Table 8-1. Obviously there can be no such standardization for do-it-yourself programs, given the nature of the individual's interaction with these programs, the wide variety of approaches that they encompass (e.g., books, devices, products, and dietary supplements), and their almost unlimited freedom to make statements and claims. To facilitate comparisons between programs, we recommend that obesity management programs collect the data summarized in Table 8-2. At the current time, it is difficult to compare different programs, in part because of differences in the clients selected and in the data collected and reported.

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Weighing the Options: Criteria for Evaluating Weight-Management Programs TABLE 8-1 Program Disclosure of Information All potential clients of weight-management programs should receive information such as the following: • A truthful, unambiguous, and nonmisleading statement of the approach and goals of the program. Part of such a statement might read, for example, "We are a program that emphasizes changes in lifestyle, with group instruction in diet and physical activity." • A brief description of the credentials of staff, with more detailed information available on request. For example, "Our staff is composed of one physician (M.D.), two registered nurses (R.N.s), three registered dietitians (R.D.s), one master's-level exercise physiologist, and one Ph.D.-level psychologist. At your first visit, you will be seen by the physician. At each visit you will be seen by a dietitian and exercise physiologist and after every five visits by the psychologist. Résumés of our staff are available on request." • A statement of the client population and experiences over a period of 9 months or more. For example, "To date, we have seen 823 clients for at least three visits each. Although only 26 clients have participated in this program for more than 1 year, they have maintained an average weight loss of 12 pounds." • A full disclosure of costs. For example, "If you avail yourself of all our facilities with one weekly visit for a period of 1 year, the total cost to you will be between $2,000 and $2,500." Costs should include the initial cost; ongoing costs and additional cost of extra products, services, supplements, and laboratory tests; and costs paid by the average client. Programs may also wish to provide information on the experiences clients have had in recovering their costs from third-party payers. • A statement of procedures recommended for clients. For example, "We urge that each of our clients see a physician before joining our program. If you have high blood pressure or diabetes, you should see your physician at intervals of his or her choosing while with our program." If programs make claims for long-term maintenance of weight loss, the percentage of clients who have lost weight and maintained it for 1 and 2 years should be provided (along with the percentage of clients for whom the information is available) as well as the average weight loss. Many companies use testimonials, often from prominent people, to show a program's success at achieving weight loss. In these cases, they should also cite the experience of their clients in general (as noted above) or cite the general experience of similar dieters taken from reports in the scientific literature. Scholarly research using data collected from weight-management companies should be conducted according to generally accepted protocols for approval and consent. We also endorse guidelines prepared by Apfelbaum et al. (1987) on information to include in scientific papers on the results of obesity treatments. The guidelines are intended to help investigators compare the results of different programs reported in the literature, which is often impossible to do now given the differences in

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Weighing the Options: Criteria for Evaluating Weight-Management Programs TABLE 8-2 Collection of Data by Weight-Management Programs 1. The number of people attending the first treatment session. (This is the group of potential clients and those who will become actual clients.) 2. Number of clients attending their first two treatment sessions (a gauge of those who have really begun a program) and percentage continuing to participate in the program at 1, 3, 6, and 12 months. (These timepoints seem reasonable but are selected somewhat arbitrarily, for while there is no set of ideal timepoints, it is important to have a set for standardization and comparison among programs. Programs may, of course, use additional timepoints.) 3. Average weight, height, BMI, and WHR of clients attending the first two sessions and appropriate measures of change in these variables at 1, 3, 6, and 12 months in the program. (These data should be assembled by gender and, if possible, by race, age, and starting weight or BMI.) 4. The percentage of actual clients who complete each of the stages of the treatment program. This means either the number of clients that complete the program's prescribed number of sessions (e.g., 8 weeks for an 8-week program) or the number of clients in treatment at 3 months. 5. The percentage of actual clients who re-enroll in the same program for further treatment. (This figure should not necessarily be interpreted as a measure of client failure in a program; it may indicate satisfaction with the program.) kinds of data reported. Apfelbaum et al. recommend that reports of research should include (1) the number of patients (or clients) considered for treatment; (2) number of patients accepted for treatment; (3) number of patients dropping out of treatment; (4) gender and age distribution of patients; (5) BMI of patients, including mean, standard deviation, median range, and interquartile range; (6) duration of treatment; (7) duration of follow-up (a minimum of 1 year strongly recommended); (8) number of patients in follow-up; (9) weight changes during follow-up, and how obtained (e.g., self-report or actual measurement); (10) waist and hip measurements before and after treatment; and (11) costs of the treatment. CONCLUDING REMARKS This chapter has provided a variety of qualitative and quantitative recommendations that, if implemented, will lead to weight-management programs' being evaluated in a more comprehensive and systematic manner than is possible today. Their implementation will also help consumers choose from among the programs in a more informed manner. These recommendations are meant to apply to programs that advertise their success at helping people lose weight and often promote their superiority over competing programs. We are aware that they will elicit both supportive and critical reactions, but we believe there is consensus that recommendations are needed and will serve a useful purpose. They are the

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Weighing the Options: Criteria for Evaluating Weight-Management Programs product of our expert committee based on the scientific research available and collective judgment, and we put them forward to generate discussion and action. It is our hope and expectation that the recommendations in this chapter will evolve and be acted upon based on such discussions, on assessment of the outcomes of the activities they generate, and on future research.