Phase 1 Study of the Effect of Mandometer on Speed of Eating and Body Weight in Patients With Binge Eating Disorder

Background: control of the speed of eating and the amount of food eaten is a major intervention in Mandometer treatment of anorexia nervosa (AN), bulimia nervosa (BN), and eating disorders not otherwise specified (EDNOS), including binge eating disorder (BED), which is an EDNOS. The control is achieved by Mandometer, which is a scale connected to a computer. The patient eats food from a plate on the scale and the computer records the weight loss of the plate over the course of the meal. Thus, the amount of food eaten and the duration of the meal are measured. This yields a measure of the speed of eating. Patients also estimate their feeling of fullness at regular intervals on a scale on the Mandometer computer screen and the computer stores the ratings. Thus, the development of satiety is also measured. AN-patients eat only little food over a long period of time. They practice eating more food at a higher speed by following training curves on the computer screen while eating. This is possible because the patients can see their own speed of eating emerging on the screen while eating and so they can adjust their speed of eating to the training curves. The patients learn to feel full in a normal manner by practicing in the same way, assisted by feedback from the Mandometer computer screen. Mandometer treatment of AN and BN has been evaluted in a randomized controlled trial, outcome of treatment of 1428 patients with eating disorders in six clinics in four countries has been reported, and the treatment has been reported to be more effective than a standard treatment in reducing body weight and improving health in obese adolescents in a randomized controlled trial. Mandometer has been cleared as an eating disorder conditioning tool, class 2 device by the FDA for the treatment of eating disorders.

Hypotheses: it is hypothesized that BED-patients eat more food at a higher speed than normal weight, healthy people. Because they do not compensate for their increased intake of food, BED-patients gain weight and become obese. It is also hypothesized that BED-patients will lose weight by practicing eating less food at a reduced speed using Mandometer.

Aims of trial: 166 BED-patients have practiced eating less food at a reduced speed at home over one week and a total of 354 BED-patients (including the 166 patients) have practiced eating in the same manner in Mandometer treatment of eating disorders. This trial aims at testing the hypothesis that BED-patients eat at a higher speed than normal weight, healthy control subjects. The trial also aims at examining whether BED-patients lose weight by practicing eating less food at a reduced speed. Normal weight, healthy control subjects will be recruited and tested for food intake and speed of eating at home over one week to meet these aims.

Patient admission and treatment: patients are continuously admitted to Mandometer treatment, which is a standard of care for eating disorders since 1997 in the Stockholm City Council. Hence, patients are treated according to the clinical practice of the Mandometer Clinic. 20% of the patients are admitted through referral within the Swedish Health Care System and 80% through self-referral, which is an option within the system. 85% of the 354 patients are women, their age and BMI were similar to those of men, their mean (SD) age at admission was 38 (15.4) years and their BMI was 37.1 (7.5) kg/m2, for women and men combined. The marked sex difference is expected, most patients with eating disorders are women. The patients first come to the clinic for instruction on how to use Mandometer at home and they return after one week for an eating examination. While eating at home over the first week using Mandometer is now part of clinical practice, this was not the case when Mandometer treatment for BED was launched. Thus, the first 354-166=188 patients who were admitted to Mandometer treatment did not eat using Mandometer at home before they entered treatment. Instead, these patients ate using Mandometer as part of the initial examination at admission. At that examination, which is referred to as an eating examination, all patients fill in the the Eating Disorders Inventory, the Comprehensive Psychopathological Self-Rating Scale, and questionnaires of the quality of life. As part of the eating examination, the patients are also examined by a physician, including blood pressure, heart and lung examination, and palpation of the stomach, and they are interviewed concerning their medical history and history of eating disorders. The patients´ body weight and composition are examined (Tanita BC-418 MA) and a record of their recent 24-hour food intake and eating habits is also taken. They are then diagnosed with BED using the Diagnostic and Statistical Manual of Mental Disorders.

Intervention: the patients are instructed in the use of Mandometer at their first visit to the clinic and they are given a Mandometer for use at home over the following week. They are encouraged to eat the foods they normally eat for lunch and dinner on five days of the week. 75% of the 166 patients had up to six meals with Mandometer in these tests. The average amount of food and the time to eat thus collected on Mandometer are loaded onto Mandobase, a custom made database used in the clinical practice of the Mandometer Clinic. The data are used to program Mandometer with training curves for the control of eating behavior, i.e., amount of food eaten and duration of the meal. The aim of Mandometer training is that patients should eat about 300-350 g of food for both lunch and dinner at a speed of about 25-30 g/min. These values correspond to those of previously tested normal weight, healthy control subjects, who ate using Mandometer in a research laboratory, but never at home. Patients are also provided with a schedule for 24-hour food intake, in which regularity of eating is stressed and between meal snacking is discouraged. Patients return to the Mandometer Clinic every sixth week for measuring their body weight and their eating behavior using Mandometer without training curves. The 188 patients who did not use Mandometer at home had their training curves similarly prepared but based on one test with Mandometer only, which was administered as part of their eating examination when they were admitted to the clinic. The patients are treated as out-patients, they come once/week over the first eight weeks and then once/second week. The average number of visits to the clinic is 30 over about a year.