"If there are no data to demonstrate that program participants maintain their weight losses for 5 years or more, there is no scientific evidence of long-term results of the program."

American Heart Association guidelines
How to evaluate
weight loss programs

     Weight loss to improve cardiovascular health and weight management are high priorities for the American Heart Association. Yet current programs lack data supporting their long-term safety and effectiveness, and therefore AHA has developed guidelines to evaluate these programs. AHA also asks program leaders to collect complete data on safety and effectiveness and make it available to the public. 
     The guidelines do not discuss surgical or pharmacological approaches, and are not intended for persons who are severely overweight (100 pounds or more above their ideal" body weight), who have preexisting illness or metabolic disorders that should be treated by a qualified health team, or for children under age 18. It is noted that information is lacking on the benefits, if any, of weight loss in the elderly, age 75 or over. 
     The American Heart Association Guidelines for Weight Management Programs for Healthy Adults, approved Feb. 16, 1994, were published in the summer issue of Heart Disease and Stroke (1994;3:221-228). Reprints available from the American Heart Association, 7272 Greenville Ave, Dallas, TX 75231. (This paragraph could be boxed as note at bottom of article, instead of here.) 
     The AHA guidelines focus on the health benefits of weight loss associated with a healthy lifestyle expected to lead to improved cardiovascular health. The information below is excerpted from the special report on these guidelines. 

Essential components
     The essential components of a safe and effective weight management program are: 

  •  Participant information; informed consent. 
  • Screening of all persons with an appropriate medical history form to identify those who require a physician's supervision. Guidelines for those who need evaluation by a physician. 
  • Staffing by qualified individuals (by education, training and experience). 
  • Identification of reasonable weight loss goals or to improve general health. 
  • 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. 
  • 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. 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. 
Consent form
     Each participant should sign a consent form witnessed by a competent adult. The consent form should describe: the number and format of contacts; a reasonable weight goal; estimated time frames for reaching the weight goal; health and psychological benefits that can be achieved through weight loss; physical and psychological risks associated with weight loss; the level of training and credentials of the people providing weight management supervision; what is necessary to comply with program contractual conditions; the actual cost of treatment, including all products, services, supplements, and laboratory tests; the need for medical monitoring in specific cases. 
     In addition, each participant should be informed about 
  • Current data on the likelihood that weight loss will be maintained (a high percentage of individuals who lose weight have regained it in 5 years). 
  • Potential physical and psychological risks associated with regaining the lost weight and with weight cycling. 
  • Scientifically valid data to substantiate any claim about the success rate of the program. 
     If there are no data to demonstrate that program participants maintain their weight losses for 5 years or more, there is no scientific evidence of long-term results of the program. Case histories of program successes are not sufficient and should not be presented as descriptive of the program's overall success rate. 

Staffing and training
     All persons providing weight management services should be qualified by education, training, and experience to provide these services. In addition to basic nutrition education and training in individualizing counseling and eating plans, all providers should have documentation of continuing education on a yearly basis in the area of weight management. 
      Registered dietitians, dietitians or nutritionists licensed or certified by the state should be responsible for the nutrition component of the weight management program. Nutrition intervention specialists not in (these) categories should be trained by these professionals and receive continuing education on a regular basis. 
     Physicians who supervise weight management programs must be licensed by the state in which they work and should . . . be knowledgeable about medical problems associated with obesity, weight loss and weight regain. People with training in exercise physiology and clinical experience in weight management should provide the exercise component of weight management. Behavior modification principles should be developed by a behavioral scientist who has the education and experience to conduct training sessions. 
     Lay leaders in the program should receive appropriate training by dietitians, exercise leaders, and behavioral scientists as indicated above. They should have ready access to health professionals for consultation, participate in regular, documented continuing education and be monitored to ensure that approved programs are being conducted as intended. 

Realistic goals
     The weight goal for the participant should be reasonable and based on personal, cultural, and family weight history, not exclusively on height and weight charts or body mass index. Setting unrealistically low weight goals virtually ensures that rapid weight loss will be followed by equally rapid regain. There is no scientifically validated method for defining optimum body weight for a given individual. . . 
     A realistic weight goal depends largely on past weight. For example, a person with a strong family history of obesity and a lifelong personal history of overweight should not be promised a final weight in the normal range. Although the participant should help set the weight goal, it is appropriate to dissuade him or her from striving for an unrealistically low weight goal. Particular care should be taken in establishing weight loss goals for people who may be at risk for eating disorders such as bulimia or anorexia nervosa. 
     Step-wise weight goals, whereby the participant agrees to work toward a modest weight reduction, can be adopted. If the initial weight loss is maintained for some agreed-upon period, further weight reduction can be attempted. 
     The advertised and actual rate of weight loss, after the first 3 to 4 weeks of treatment, should not exceed an average of 1 pound per week. Slow, gradual weight loss rather than rapid weight loss is recommended because it minimizes the risk of metabolic disturbances and is less likely to induce a state of extreme energy deprivation, which can result in reduced compliance. Rapid weight loss is associated with the most rapid rate of subsequent weight regain. A person whose average rate of weight loss greatly exceeds 1 pound per week may be at increased health risk and may require closer and more frequent medical supervision. 

Diet and nutrition
     The nutritional recommendations for each participant's treatment should include a personal food plan that takes into account current eating habits, lifestyle, ethnicity and culture, energy needs, any diet prescription related to medical treatment, and potential nutrient-drug interactions. Specific goals related to food intake, behavioral changes, and physical activity need to be established and discussed at each follow-up visit . . . Energy intake should be reevaluated periodically to ensure that the rate of weight loss does not greatly exceed the 1 pound per week average. Health risks from weight loss increase as energy intake decreases. A minimum of 1,200 calories per day for women and 1,500 per day for men should be provided. 
     Diet composition should be consistent with the AHA's dietary guidelines. Protein should provide about 15 percent of energy and be of high biological value. Less than 30 percent of energy should be from fat; less than 10 percent of energy should be from saturated fatty acids, up to 10 percent should be from polyunsaturated fatty acids, and the remainder should be from monounsaturated fatty acids. The diet should provide 55 percent or more of energy as carbohydrate, the majority being complex carbohydrates. Diets rich in complex carbohydrate and fiber are consistent with health promotion and disease prevention in healthy people. 
     Nutrition education should be incorporated into the weight management program to encourage permanent healthful eating patterns consistent with the AHA dietary guidelines for healthy American adults. Participants should avoid crash dieting and instead gradually adopt more healthful eating habits that can be maintained for a lifetime. Selection and preparation of low-fat foods and selection of low-fat alternatives while dining out should be emphasized. 
     Participants should be involved in meal planning and food decisions throughout the weight loss period to encourage the practice of healthful food selection skills. The range of food options during the weight loss period should be as broad as possible and ethnically and culturally acceptable to each person. Educating about including familiar, highly desired foods in the food plan can help reduce feelings of extreme deprivation, improving adherence. 

     [Appendix B gives information on very low calorie diets and concludes that long-term maintenance of weight lost with very-low-calorie diets is not very satisfactory.] 

Exercise 
     Exercise should be considered one of the highest priorities of a weight management program. The weight management program should include an exercise component that is safe and appropriate for each participant. 
     Before exercise recommendations are made, each person should be screened for conditions in which exercise could be contraindicated. Participants should be made aware of both normal and abnormal physiological responses to exercise. They should work toward performing at least 30 to 60 minutes of physical activity five to seven times per week. In addition, increasing leisure-time activity levels should be encouraged. The activity can be any exercise that uses large muscle groups and is rhythmic. It should be consistent with individual interests and an activity that can become a permanent part of the lifestyle. Low-impact aerobic activities such as walking and bicycling are desirable because they are less likely to cause orthopedic injury and they carry a smaller risk of cardiovascular complications. They are also more likely than more intense activities to be continued. 
     The exercise should begin at a comfortable pace and be increased gradually. Progressing too rapidly will result in muscle soreness, fatigue, increased cardiac risk, and decreased motivation. 
     Water intake during exercise should be ample to prevent dehydration and overheating. Very overweight people may be particularly vulnerable to heat exhaustion. Participants may drink water before, during and after exercise and should pay close attention to thirst so that dehydration does not occur, particularly in hot weather. 
     People with conditions such as diabetes, hypoglycemia, peripheral vascular disease, and blood volume changes should be medically supervised. These people need to be aware of warning symptoms of their disease that may surface during physical activity. People with diabetes and vascular disease need to be aware of the importance of excellent foot care when they begin an exercise program. 

Maintenance
     Weight management programs should include a maintenance component for participants who reach their weight goals. Several factors may be associated with long- term weight maintenance: incorporation of exercise into the permanent lifestyle, self-monitoring techniques after weight loss has been achieved, lapse/relapse prevention strategies, and social support for individual lifestyle changes. 
     The success of a program is ultimately reflected by long-term maintenance of weight loss and healthy lifestyle habits. 
     Achievement of a desirable body weight is not realistic for all participants, and desirable body weights do not always reflect ethnic diversity and gender differences; therefore maintaining a reasonable weight loss, rather than achieving an ideal body weight, should be equated with success. Undue pressure to achieve an unattainable weight can be counterproductive and undermine long-term maintenance of small to moderate weight loss. 

Excerpted from Special Report: American Heart Association Guidelines for Weight Management Programs for Healthy Adults, AHA Medical/Scientific Statement, American Heart Association. Reprints from: Office of Scientific Affairs, AHA, 7272 Greenville Ave, Dallas TX 75231-4596 (1-800-242-8721).
 

Collecting program data 

Data should include: 

     1. Definitions for the length of the weight loss and weight 
         maintenance phases of the program. 
     2. Percent of all participants who completed the program. 
     3. Percent of those completing the initial weight loss phase of
         the program who achieve various degrees of weight loss
         and weight gain, including the mean and range. 
     4. Percent who began and completed the weight maintenance 
         phase of the structured program (self-reported data not
         acceptable). 
     5. Percent who maintain weight loss at 1, 2 and 5 years. 
     6. Percent with improved disease risk factor status at 1, 2 and
         5 years. 
     7. Percent who experience adverse medical or psychological 
         effects and the nature and severity of these effects. 
     8. Reasons for dropping out. 
     9. Percent who meet their goals. 
     Data should be collected at baseline to determine long- and short-term complications of weight loss . . . Negative sequelae of excessive weight loss may be determined through a brief, general health inquiry at each visit. Any changes in health, mood, or physical or mental performance or the presence of symptoms should be noted, as should headaches, fatigue, emotional distress, loss of lean muscle mass or muscle aching, palpitations, postprandial symptoms, changes in menstrual cycle, hair loss, abdominal discomfort, or edema, among other symptoms. These data should be maintained in aggregate form. Data on the number and nature of referrals to physicians should be recorded. 
     It is important that aggregate data from participants be made available to the public to ensure the program's safety and effectiveness. Data should be recorded on average weight loss, the range of weight loss, and all negative health consequences that require physician referral. 
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