Submitted for Publication 10/2009 - M. S. Roslin, MD FACS1, R. H. Brauner, MS2, and J.A. Dixon, MBBS,.PhD FRACGP3
A randomized controlled study of Scientific Intake’s Sensor Monitored Alimentary Restriction Therapy (SMART™) Device was conducted on 173 overweight or obese (BMI 26-36 kg/m2) adult subjects at 5 centers. The device is placed by the user below the hard palate to mimic torus palatinus, decreasing the capacity of the oral cavity to slow eating, reduce bolus size, promote thorough chewing, increase savoring and induce satiety to reduce caloric intake. Subject-made impressions were used to manufacture devices which were provided to the treatment group to use when eating for 16 weeks. Device-embedded microsensors provided data to graph usage. Fortnightly, all subjects were assessed and received video nutritional and exercise advice. Minimum usage requirements were added during the study and non-compliant subjects excluded.
There were 108 evaluable subjects. The treatment group (n=41) had a significantly greater chance (48.8% vs. 4.5%) of losing >5% of their initial body weight than the control group (n=67) and the two groups experienced 38.1% and 2.5% excess weight loss, respectively (p<0.0001). There was a highly significant negative correlation between use of the device and percent weight change – those who used the device most lost more weight. There were no serious adverse events.
The effectiveness and minimal risk of this unique non-invasive device in reducing dietary intake suggest that it can be a very valuable treatment for overweight and obesity.
1Lenox Hill Hospital , New York, NY 2Touro College of Osteopathic Medicine, New York, NY 3 Monash University and Baker IDI Heart and Diabetes Institute. Melbourne, VIC, Australia