Binge-Eating Disorder Clinical Trial
Official title:
Phase 1 Study of the Effect of Mandometer on Speed of Eating and Body Weight in Patients With Binge Eating Disorder
Verified date | November 2015 |
Source | Mando Group AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Institutional Review Board |
Study type | Interventional |
Patients diagnosed with Binge Eating Disorder (BED) overeat food but, as opposed to patients with bulimia nervosa, they do not compensate for their increased food intake and therefore their body weight increases. It is hypothesized that the speed of eating has increased in BED and that body weight will decrease if the speed of eating is decreased. The speed of eating is measured using Mandometer, an eating disorder conditioning tool, class 2 device cleared by the FDA for the treatment of eating disorders. Mandometer is a scale connected to a computer, patients eat food from a plate on the scale and the computer stores the weight loss of the plate, thus recording the speed of eating. Patients decrease their speed of eating by following training curves on the computer screen while eating. The emergence of their own speed of eating on the screen makes this possible. Patients use Mandometer for lunch and dinner over one week at home to estimate their speed of eating and their food intake as the first step of clinical pratice. Mandometer is then programmed with how much and how quickly to eat and patients practice eating using Mandometer at home over the subsequent treatment. Data from 166 BED-patients using Mandometer at home and from a total of 354 patients who have been treated have been collected. 30 normal weight, healthy subjects will be recruited to test the hypothesis that their speed of eating is lower than that of the BED-patients. These control subjects will eat lunch and dinner using Mandometer at home over one week, but they will, obviously, not participate in treatment.
Status | Completed |
Enrollment | 386 |
Est. completion date | November 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 28 Years to 56 Years |
Eligibility |
Inclusion Criteria: - patients with binge eating disorder and normal weight, healthy controls Exclusion Criteria: - ongoing drug abuse and/or other psychiatric diagnosis than binge eating disorder |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Mandometer Clinic | Huddinge | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Mando Group AB |
Sweden,
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Bergh C, Callmar M, Danemar S, Hölcke M, Isberg S, Leon M, Lindgren J, Lundqvist A, Niinimaa M, Olofsson B, Palmberg K, Pettersson A, Zandian M, Asberg K, Brodin U, Maletz L, Court J, Iafeta I, Björnström M, Glantz C, Kjäll L, Rönnskog P, Sjöberg J, Söder — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from baseline eating disorder symptoms measured by Eating Disorder Inventory questionnaire at 12 months | eating disorder symptoms will be assessed by the Eating Disorder Inventory, a questionnaire | every sixth week up to 52 weeks | No |
Other | Change from baseline anxiety measured by the Comprehensive Psychopathological Rating Scale at 12 months | anxiety till be assessed by the Comprehensive Psychopathological Rating Scale | every sixth week up to 52 weeks | No |
Other | Change from baseline food intake measured by the Comprehensive Psychopathological Rating Scale at 12 months | depression be assessed by the Comprehensive Psychopathological Rating Scale | every sixth week up to 52 weeks | No |
Other | Change from baseline obsessions measured by the Comprehensive Psychopathological Rating Scale at 12 months | obsessions be assessed by the Comprehensive Psychopathological Rating Scale | every sixth week up to 52 weeks | No |
Other | Change from baseline quality of life measured by the PEDsQL questionnaire at 12 months | quality of life be assessed by the questionnaire PEDsQL | every sixth week up to 52 weeks | No |
Primary | Change from baseline speed of eating at 12 months via Mandometer scale | the speed at which food is consumed will be assessed by a scale connected to a computer | every sixth week up to 52 weeks | No |
Secondary | Change from baseline food intake at 12 months via Mandometer scale | amount of food eaten will be assessed by a scale connected to a computer | every sixth week up to 52 weeks | No |
Secondary | Change from baseline body weight at 12 months using BMI calculation | body mass index calculated, weight in kg/height in m squared | every sixth week up to 52 weeks | No |
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