First Australian experiences with an oral volume restriction device to change eating behaviors and assist with weight loss.

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.