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Trial record 50 of 592 for:    binge eating disorder

Reduction of the Speed of Eating as an Intervention in Obesity

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ClinicalTrials.gov Identifier: NCT02381327
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
Mando Group AB

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Device: Mandometer Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 386 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Effect of Mandometer on Speed of Eating and Body Weight in Patients With Binge Eating Disorder
Study Start Date : February 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Binge Eating Disorder
Patients with Binge Eating Disorder will use Mandometer as an intervention to reduce food intake and speed of eating.
Device: Mandometer
Mandometer is an eating disorder conditioning tool, class 2 device cleared by the FDA for the treatment of eating disorders. Mandometer offers on-line, real-time feedback on how much food to eat and how quickly to eat during a meal.

Experimental: Control
Normal weight, healthy control subjects will use Mandometer to obtain data for comparison with the patients with Binge Eating Disorder.
Device: Mandometer
Mandometer is an eating disorder conditioning tool, class 2 device cleared by the FDA for the treatment of eating disorders. Mandometer offers on-line, real-time feedback on how much food to eat and how quickly to eat during a meal.




Primary Outcome Measures :
  1. Change from baseline speed of eating at 12 months via Mandometer scale [ Time Frame: every sixth week up to 52 weeks ]
    the speed at which food is consumed will be assessed by a scale connected to a computer


Secondary Outcome Measures :
  1. Change from baseline food intake at 12 months via Mandometer scale [ Time Frame: every sixth week up to 52 weeks ]
    amount of food eaten will be assessed by a scale connected to a computer

  2. Change from baseline body weight at 12 months using BMI calculation [ Time Frame: every sixth week up to 52 weeks ]
    body mass index calculated, weight in kg/height in m squared


Other Outcome Measures:
  1. Change from baseline eating disorder symptoms measured by Eating Disorder Inventory questionnaire at 12 months [ Time Frame: every sixth week up to 52 weeks ]
    eating disorder symptoms will be assessed by the Eating Disorder Inventory, a questionnaire

  2. Change from baseline anxiety measured by the Comprehensive Psychopathological Rating Scale at 12 months [ Time Frame: every sixth week up to 52 weeks ]
    anxiety till be assessed by the Comprehensive Psychopathological Rating Scale

  3. Change from baseline food intake measured by the Comprehensive Psychopathological Rating Scale at 12 months [ Time Frame: every sixth week up to 52 weeks ]
    depression be assessed by the Comprehensive Psychopathological Rating Scale

  4. Change from baseline obsessions measured by the Comprehensive Psychopathological Rating Scale at 12 months [ Time Frame: every sixth week up to 52 weeks ]
    obsessions be assessed by the Comprehensive Psychopathological Rating Scale

  5. Change from baseline quality of life measured by the PEDsQL questionnaire at 12 months [ Time Frame: every sixth week up to 52 weeks ]
    quality of life be assessed by the questionnaire PEDsQL



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Ages Eligible for Study:   28 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381327


Locations
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Sweden
Mandometer Clinic
Huddinge, Stockholm, Sweden, 14104
Sponsors and Collaborators
Mando Group AB
Investigators
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Principal Investigator: Per Sodersten, PhD Karolinska Institutet
Study Chair: Maryam Esfandiari, MS Karolinska Institutet

Publications of Results:
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Responsible Party: Mando Group AB
ClinicalTrials.gov Identifier: NCT02381327     History of Changes
Other Study ID Numbers: Mando-1
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015

Keywords provided by Mando Group AB:
Speed of eating
body weight
food intake

Additional relevant MeSH terms:
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Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms