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When Is Weight Loss Surgery Recommended?
“I can say with confidence that they haven’t tested it carefully enough to prove that it does work,” Aamodt wrote in an email to The Verge. “If someone approached the FDA for approval of a weight-loss drug based on evidence like this, they’d be laughed out of the building.” As Aamodt points out, one study the company has done has not passed peer review or been published in an academic journal. It followed only nine people for 16 weeks, and the change in total body fat was not statistically significant. Fundamentally, there is little evidence that the device can change the body’s set point. Usually, the set point kicks in (and we start to gain the weight back) after six months, so a 16-week study can’t tell us anything about long-term weight regulation or keeping the weight off. (McKeown suggests using the device elyze a couple times a week for maintenance, after using it four or five times weekly to lose the weight at first.) It’s also possible, says Aamodt, that the small results are because the headset can create a swaying feeling similar to motion sickness, which is associated with loss of appetite. True, I did not feel like eating while feeling vaguely nauseated. Because the device is new, we also don’t have good, long-term data that proves that it doesn’t work, either. Modius seems to be initiating a clinical trial , but it’s in the recruiting stage. It is also interested in possibly obtaining FDA approval as an obesity treatment by 2019.
For the original version including any supplementary images or video, visit https://www.theverge.com/2018/1/9/16864374/modius-health-headset-neuroscience-weight-loss-wearables-ces-2018