CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 386 enrolled
Drug / intervention
Mandometerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02381327
NCT02381327Phase 1Completed

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

Mando Group AB·interventional·Posted Mar 6, 2015·Updated Nov 26, 2015

In Brief

A Phase 1 clinical trial evaluating Mandometer for Binge-Eating Disorder. Completed, enrolled 386 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 6, 2015
Enrollment StartFeb 1, 2015
Primary CompletionSep 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.3 years ago

Interventions

Mandometerdevice

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.