Human Neurotransmitters Laboratory and Vascular and Hypertension Division-Obesity Research, Baker IDI Heart and Diabetes Institute, Melbourne, Victoria, Australia.
Obesity (Silver Spring). 2012 Jan;20(1):126-33. doi: 10.1038/oby.2011.303. Epub 2011 Oct 20.
Eating behaviors impact satiety and caloric intake so should be considered in any weight-loss program. A novel custom-made oral device has been designed to be worn in the upper palate while eating in order to slow eating-rate and aid weight loss. The aim of this study was to assess the device's potential impact on weight-loss and gain first impressions among overweight/obese Australians. Twenty participants (M: 6, F: 14, mean age 36 years, BMI 27-33 kg/m(2)) were enrolled in a 4-month open-label trial. Each received a device and nutritionist-delivered diet plan. Weight, compliance, and acceptability were assessed fortnightly. Anthropometry, biochemical and clinical outcomes were measured at baseline and 16 weeks. Sixteen participants completed the study. Mean weight-loss was 4.9 ± 0.9 kg, or 5.2 ± 0.9% initial bodyweight (P < 0.001, n = 20, intention-to-treat). There were no significant adverse events (AEs), but 65% of participants required device adjustment by the dentist. Compliance (defined as >5 uses/week) was achieved by 80% of participants and correlated positively with weight-loss (R = 0.68, P = 0.001). All reported that the device was comfortable and reduced bite-size, promoted chewing and slowed eating-rate. Most observed either no change, or increased satiety, despite reduced meal sizes. For most, speech difficulties discouraged device use in social settings. All reported greater awareness of food choices, portion sizes and eating-rate. Subjective control of dietary behaviors, measured by the Three Factor Eating Questionnaire (TFEQ), improved significantly. The device should be explored as an adjunct to dietary composition change in weight-management programs, to assist patients to modify eating behaviors and achieve successful weight-loss.
饮食习惯会影响饱腹感和热量摄入，因此应在任何减肥计划中加以考虑。一种新型的定制口腔装置已被设计用于在上颚佩戴，以减缓进食速度并帮助减肥。本研究旨在评估该装置对超重/肥胖澳大利亚人的减肥效果和初步印象。20 名参与者（男性 6 名，女性 14 名，平均年龄 36 岁，BMI 27-33kg/m2）参加了为期 4 个月的开放性试验。每个参与者都收到了一个装置和营养师提供的饮食计划。每两周评估一次体重、依从性和可接受性。在基线和 16 周时测量人体测量学、生化和临床结果。16 名参与者完成了研究。平均体重减轻 4.9 ± 0.9kg，或初始体重的 5.2 ± 0.9%（P < 0.001，n = 20，意向治疗）。没有发生重大不良事件（AE），但 65%的参与者需要由牙医调整装置。80%的参与者达到了>5 次/周的使用依从性，且与体重减轻呈正相关（R = 0.68，P = 0.001）。所有参与者均报告称该装置舒适，可减少咬口大小，促进咀嚼和减缓进食速度。尽管每餐的份量减少，但大多数人观察到要么没有变化，要么增加了饱腹感。对于大多数人来说，由于言语困难，在社交场合使用该装置会受到阻碍。所有人都报告称，他们对食物选择、份量和进食速度的意识增强。通过三因素饮食问卷（TFEQ）测量的饮食行为的主观控制显著改善。该装置应在饮食成分改变的体重管理计划中作为辅助手段进行探索，以帮助患者改变饮食行为并成功减肥。
