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Efficacy and safety of an oral device to reduce food intake and promote weight loss.


ABSTRACT: Objective: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. Methods: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. Results: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). Conclusion: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, on average, and greater chance of achieving ?4% or ?5% weight loss.

SUBMITTER: Ryan DH 

PROVIDER: S-EPMC5818751 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Efficacy and safety of an oral device to reduce food intake and promote weight loss.

Ryan D H DH   Parkin C G CG   Longley W W   Dixon J J   Apovian C C   Bode B B  

Obesity science & practice 20171211 1


<h4>Objective</h4>Minimal risk weight loss tools are needed. This study's objective was to confirm Food and Drug Administration submissions of the SmartByte<sup>™</sup> System's safety and efficacy.<h4>Methods</h4>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<sup>-2</sup>.<h4>Results</h4>Seventy-six subjects received the devic  ...[more]

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