From: Brian Williams [brian.williams@heart.org] Sent: Friday, November 21, 2003 1:53 PM To: 'FDADockets@oc.fda.gov' Subject: Docket No. 2003N-0338 - Obesity Questions American Heart Association Response to Questions Posed at FDA Public Meeting on Obesity Docket No. 2003N-0338 Federal Register Notice. October 8, 2003. The October 23, 2003, meeting of the FDA's Obesity Working Group focused on the following six (6) questions: FDA: (1) What is the available evidence on the effectiveness of various education campaigns to reduce obesity? AHA: Very few programs have focused on obesity prevention and some that have had limited sample sizes and limited follow-up; thus the evidence for the effectiveness of programs is limited. In a review of school-based studies to prevent obesity, Story (1999) reported that all of the studies included both physical activity and nutrition education. The results of the school-based treatment programs were encouraging and showed positive but modest, short-term results. It was noted that intervening with children in the pre-adolescent phase resulted in more success than when intervening during the teenage years. Three major components were recommended for use in intervention programs: classroom for health education, the school food service, and physical education programs. Most successful programs include an emphasis on physical activity, often using dance among young females. There are promising programs currently being conducted, for example the community-based obesity prevention program for minority children called Hip-Hop to Health Jr. is targeting preschool African-American and Latino children in Chicago (Fitzgibbon et al, 2002). Knowing the difficulty that one faces in the treatment of obesity, it is advantageous to begin with primary prevention. Pre-school programs such as Head Start and K through 9 can take a population-based approach and use the schools to reduce the number of children who become obese. It is worth noting that programs that target cardiovascular disease (CVD) target similar aspects of lifestyle and behaviors. Two successful CVD risk reduction programs were school-based and longer in length and warrant review (Van Horn et al, 1994; the DISC Writing Group, 1995; Luepker et al, 1996). The DISC Study included seeing elementary level school children with their family and also telephone contacts in the second and third year. The CVD risk reduction program reported by Luepker included school food based service, physical education with physical activity comprising 40% of the physical ed class, and a classroom curricula. The DISC study lasted 3 years and showed significant differences in fat intake between the treatment and control groups, while Luepker also reported significant differences in fat and cholesterol consumption among intervention group students in a large sample that crossed four states. Weight loss to improve cardiovascular health is a high priority of the American Heart Association because approximately 65% of the population is overweight or obese. There is a great deal of public, commercial, and medical interest in promoting long-term weight loss programs. Several studies using behavioral interventions and strategies to enhance compliance to weight loss treatment show what measures are effective for losing weight and weight maintenance, as long as the subjects continue to participate in active intervention, such as a regular exercise regimen. Long-term follow-up shows that physical activity and exercise is the most important determinant of weight loss maintenance. However, the biggest issue in these programs is that they are time limited and the individual needs to maintain the lifestyle changes without the support of the study team or others, which often results in recidivism. This highlights the issue of long-term care of a chronic disorder. Individuals who have been successful in losing weight are left on their own to maintain that loss. One can not refer them to a physician because this problem is usually not addressed in medical practice. Survey have shown that less than 50% of physicians discuss physical activity and diet with their overweight or obese patients, nurse practitioners are no better in addressing this problem. Without regular follow-up, patients slip back into their previous habits and regain the weight. This pattern suggests that educating health care professionals on how to intervene with patients facing a weight control problem may have an impact, especially with the continuous increase in the prevalence of overweight and obesity. Physicians relate that they do not feel comfortable discussing it and also that they are not reimbursed for their services of dietary counseling. This suggests two campaigns that could be undertaken, first, similar to the Cholesterol Education Program of the 1980's, we could develop an education campaign targeting health professionals and educating them how to manage this problem in everyday practice. The fact is that addressing weight control and weight management indirectly addresses dyslipidemia, diabetes prevention, hypertension management and numerous other CVD risk factors. This type of educational campaign has not been tried with obesity but was successful in the improved management by physicians and nurses in hypercholesterolemia. The second campaign that needs to be conducted is a movement towards reimbursement for preventive services, which includes counseling about eating and exercise habits. Improving health professionals' skills to deliver the service and providing incentives for the delivery of care could have a major impact on the long-term management of this disorder. Also, the FDA can build on the knowledge that has been gained from the studies of behavioral weight loss and of professional education programs. These studies show the strong influence of the environment on eating and exercise behaviors. Thus, we need to develop major public education campaigns to educate the public about healthful eating and exercise habits and the threats associated with obesity, similar to what has been done in the past with hypertension and hypercholesterolemia. The AHA believes that some general, common-sense guidelines can serve as a basis for recommendations to the general public. We believe that the essential components of a safe and effective weight management program are: Participant/patient information (informed consent) Screening of all persons beginning a weight management program by use of an appropriate medical history form to identify people who require a physician's supervision Guidelines for those who need to be evaluated by a physician before beginning a weight management program Staffing by individuals qualified by education, training, and experience to provide these services Identification of reasonable weight loss goals Individualized nutritional, exercise, and behavioral components as needed with the major part of treatment conducted through the group process A maintenance program for at least 2 years Evaluation of the long-term effectiveness and safety of the program by review of weight loss and health status of all participants after completion of the program and at 1, 2, and 5 years after program completion (i.e., data on the number of participants who begin the program, the number who complete the program, and participants' weight and health status [blood pressure, blood lipids, and any health complications] should be reported, stratified by gender, at these intervals; information on the number of participants who restart the program should be reported separately) Participants in most weight loss programs meet once a week during the initial phase, which generally lasts from 12 to 24 weeks. Because participants should be followed up for a full year, 12 contacts during the first year appears to be a reasonable minimum number of contacts. FDA: (2) What are the top priorities for nutrition research to reduce obesity in children? AHA: Although only about 1/3 of adult obesity begins in children, childhood overweight is a significant problem in modern society. Among the many areas of nutrition research which are helping to explain the dramatic rise in childhood overweight, we believe the Food and Drug Administration can more closely examine the effect of food and beverage marketing and advertising on children. Coupled with increased television viewing time, as well as time spent on the internet, we believe the "face time" of food and beverage marketers with children has had an effect on the eating habits of children and families. Other top priorities for nutrition research should include examining school feeding programs, physical education programs, and nutrition education classes that teach lifelong skills in nutrition and physical activity. FDA: (3) What is the available evidence that FDA can look to in order to guide rational, effective public efforts to prevent and treat obesity by behavioral or medical interventions, or combinations of both? AHA: In addition to the recommendations provided in response to question #1, the American Heart Association has been intrigued by the recent efforts of the Centers for Disease Control and Prevention to use mass media to effect behavior change. The Youth Media Campaign is a nation-wide media campaign aimed at pre-teen children. It is designed to encourage physical activity. The campaign is called: VERB, it's what you do. Likewise, the food and beverage industry spends billions of dollars in mass media designed to encourage product purchase. Virtually all of the largest U.S. corporations use media as a way to change consumer behavior. We believe mass media has been largely ignored by the government (and other organizations interested in public health) as a way to prevent and treat obesity. FDA: (4) Are there changes needed to food labeling that could result in the development of healthier, lower calorie foods by industry and the selection of healthier, lower calorie foods by consumers? AHA: The American Heart Association believes that the upcoming addition of trans-fat to the food labeling requirements will provide additional valuable information to consumers who are trying to make healthy choices. A recurring concern of the American Heart Association and others is the inconsistency of the required food labels and other federal government nutrition education tools, such as the Food Guide Pyramid. Furthermore, the Nutrition Fact Panel itself is often confusing and difficult to interpret. The Fact Panel often forces consumers to calculate the nutrition information by multiplying with the number of servings. For instance, a bottle of juice from a vending machine indicates 130 calories, but consumers must multiply 130 by the number of servings in the bottle, which is often 1.5 or 2 or more. Therefore, the total calories for the entire package as well as for a serving size should be included. Other innovative labeling ideas might include adding the amount of physical activity needed to burn the calories contained in the food product. One might also consider adding some footnotes to explain some of the items on the label, as well undertaking a public education campaign to inform the public about how to read the food label. Making the label itself larger and possibly more prominent on the package may help the public to pay more attention to its contents. In order to achieve improved portion size control, it might be emphasized on the package when it contains more than one serving. The FDA should consider taking the labeling of foods beyond the package, for example, have major chain restaurants include nutrient content on the menu, and have hospitals and other large institutions include information on the food that is being served in the cafeteria food line. FDA: (5) What opportunities exist for the development of healthier foods/diets and what research might best support the development of healthier foods? AHA: Several newer technologies used by some food manufacturers should find more and better ways to make healthier foods. As we learn more about flavonols, phytochemicals, and so forth, opportunities should exist for manufacturing more foods with these components. Challenges and opportunities continue to exist for food technologists to produce food with less sodium, but which taste good. Similarly, new technology should prompt food manufacturers to make more trans-fat free foods. Furthermore, food manufacturers can determine which foods lend themselves to supplementation with vitamins and minerals while assuring the safety of the resultant product. Achieving these goals requires preliminary research to determine whether it is attainable, whether it is safe, and whether it is acceptable to the consumer. Making foods more healthful often alters their taste, which implies that the FDA needs to support research into taste. Since we are such a diverse population, food manufacturers have the opportunity to develop tastier and more healthful food products for different ethnic groups. Finally, the FDA can do more consumer research designed to determine what would motivate consumers to choose healthful foods. FDA: (6) Based on the scientific evidence available today, what are the most important things that FDA could do that would make a significant difference in efforts to address the problem of overweight and obesity? AHA: Obesity is clearly an emerging epidemic that must be addressed. Examining cultural, social, and behavioral trends, and finding ways to educate Americans about healthy eating and physical activity should be a top priority of the FDA. Providing more information to consumers and educating consumers about the meaning of food content, calories, and so forth, will empower consumers to make healthy choices. Understanding the relationship between food intake and energy expenditure will also help consumers make healthy choices. In addition, studies have shown repeatedly the importance of physical activity. Studies conducted outside the health care arena have shown the impact of the community on physical activity, for example the impact of poor and unsafe neighborhoods, suburbs without sidewalks, communities without pedestrian walkways or overpasses, conditions that force individuals to not exercise for safety reasons. The FDA could facilitate the convening of multiple groups, from city planners and building architects to food industry representatives, to address this problem at the societal level since that is where a big part of the solution lies in the prevention of obesity and in the maintenenance of weight loss among those successful in having reduced their weight.