Abstract
Minimal risk weight loss tools are needed. This study's objective was to confirm Food and Drug Administration submissions of the SmartByte™ System's safety and efficacy. This 16-week, prospective, single-arm, four-centre, observational study assessed the oral device in combination with a video-delivered lifestyle programme in adults aged 18-49 years with body mass index 27 to <35 kg m-2. Seventy-six subjects received the device and video lifestyle instruction. The prespecified per protocol (PP) population (N = 40) required sensor-verified use of the device ≥7 times per week for 14 of 16 weeks, overall device usage rate of ≥33% and study completion. At week 16, 12 (30%) achieved ≥5% weight loss, 16 (40%) achieved ≥4% and 21 (52.5%) achieved ≥3%. Week 16 mean loss for the PP population was 2.93%, and among 36 participants who did not meet PP criteria, it was 1.45%. Among 76 intent-to-treat subjects, two subjects reported three mild to moderate device-related adverse events, resolving spontaneously (one hard palate abrasion and two tongue lacerations). The System, a minimal risk tool, can help individuals achieve meaningful weight loss, when used with a lifestyle video. More frequent device use was associated with more weight loss...Continue Reading
References
Mar 3, 1998·International Journal of Obesity and Related Metabolic Disorders : Journal of the International Association for the Study of Obesity·K M FlegalC L Johnson
Feb 8, 2002·The New England Journal of Medicine·William C KnowlerUNKNOWN Diabetes Prevention Program Research Group
Dec 17, 2004·Obesity Research·Heather M WaldenDonald A Williamson
Aug 29, 2006·Diabetes Care·Richard F HammanJudith Wylie-Rosett
Oct 23, 2008·BMJ : British Medical Journal·Koutatsu MaruyamaHiroyasu Iso
Nov 11, 2008·Physiology & Behavior·Modjtaba ZandianPer Södersten
Dec 18, 2008·Physiology & Behavior·Modjtaba ZandianPer Södersten
Jan 7, 2010·BMJ : British Medical Journal·Anna L FordJulian P H Shield
May 20, 2011·Diabetes Care·Rena R WingUNKNOWN Look AHEAD Research Group
Aug 2, 2011·Journal of the American Dietetic Association·Sook Ling LeongCaroline Horwath
Oct 22, 2011·Obesity·Toni L McGeeJohn B Dixon
May 23, 2012·Physiology & Behavior·Cees de Graaf
Sep 29, 2012·Appetite·C G FordeN Martin
Jan 18, 2013·Annals of the New York Academy of Sciences·Raymond CarvajalCaroline H Moran
Nov 16, 2013·JAMA : the Journal of the American Medical Association·Susan Z Yanovski, Jack A Yanovski
Dec 20, 2013·JAMA Surgery·Su-Hsin ChangGraham A Colditz
Jun 2, 2014·Lancet·Marie NgEmmanuela Gakidou
Dec 3, 2014·BMJ Open Diabetes Research & Care·Theodoros AngelopoulosCarel Wynard le Roux
Apr 2, 2015·Gastrointestinal Endoscopy·UNKNOWN ASGE Bariatric Endoscopy Task ForceSubhas Banerjee
Apr 15, 2015·Surgery for Obesity and Related Diseases : Official Journal of the American Society for Bariatric Surgery·Jaime PonceUNKNOWN REDUCE Pivotal Trial Investigators
Feb 13, 2016·Lancet·George A BrayJohn P H Wilding
Nov 20, 2016·Obesity Reviews : an Official Journal of the International Association for the Study of Obesity·Jeffrey M RogersLeah Brennan
Jan 19, 2017·The New England Journal of Medicine·Steven B Heymsfield, Thomas A Wadden