PMID- 22016093 OWN - NLM STAT- MEDLINE DCOM- 20120412 LR - 20120813 IS - 1930-739X (Electronic) IS - 1930-7381 (Linking) VI - 20 IP - 1 DP - 2012 Jan TI - First Australian experiences with an oral volume restriction device to change eating behaviors and assist with weight loss. PG - 126-33 LID - 10.1038/oby.2011.303 [doi] AB - 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. FAU - McGee, Toni L AU - McGee TL AD - Human Neurotransmitters Laboratory and Vascular and Hypertension Division-Obesity Research, Baker IDI Heart and Diabetes Institute, Melbourne, Victoria, Australia. FAU - Grima, Mariee T AU - Grima MT FAU - Hewson, Ian D AU - Hewson ID FAU - Jones, Kay M AU - Jones KM FAU - Duke, Ellen B AU - Duke EB FAU - Dixon, John B AU - Dixon JB LA - eng PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20111020 PL - United States TA - Obesity (Silver Spring) JT - Obesity (Silver Spring, Md.) JID - 101264860 SB - IM MH - Adult MH - Australia/epidemiology MH - Energy Intake MH - Equipment Design MH - Female MH - Humans MH - Male MH - Materials Testing MH - Obesity/epidemiology/prevention & control/*therapy MH - Patient Compliance MH - Prostheses and Implants MH - Treatment Outcome MH - *Weight Loss EDAT- 2011/10/22 06:00 MHDA- 2012/04/13 06:00 CRDT- 2011/10/22 06:00 PHST- 2011/10/22 06:00 [entrez] PHST- 2011/10/22 06:00 [pubmed] PHST- 2012/04/13 06:00 [medline] AID - oby2011303 [pii] AID - 10.1038/oby.2011.303 [doi] PST - ppublish SO - Obesity (Silver Spring). 2012 Jan;20(1):126-33. doi: 10.1038/oby.2011.303. Epub 2011 Oct 20.