We have located links that may give you full text access.
Efficacy and safety of an oral device to reduce food intake and promote weight loss.
Obesity Science & Practice 2018 Februrary
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.
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.
Full text links
Related Resources
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app