title: Persistent weight loss with a non-invasive novel medical device to change eating behaviour in obese individuals with high-risk cardiovascular risk profile.
abstract: In evidence-based weight-loss programs weight regain is common after an initial weight reduction. Eating slowly significantly lowers meal energy intake and hunger ratings. Despite this knowledge, obese individuals do not implement this behaviour. We, thus tested the hypothesis of changing eating behaviour with an intra-oral medical device leading to constant weight reduction in overweight and obesity. Six obese patients (6 men, age 56 ± 14, BMI 29 ± 2 kg / m2) with increased CVRF profile were included in this prospective study. All patients had been treated for obesity during the last 10 years in a single centre and had at least 3 frustrate evidence-based diets. Patients received a novel non-invasive intra-oral medical device to slow eating time. Further advice included not to count calories, to avoid any other form of diet, to take their time with their meals, and to eat whatever they liked. This device was used only during meals for the first 4 to 8 weeks for a total of 88 [20-160] hours. Follow-up period was 23 [15-38] months. During this period, patients lost 11% [5-20%] (p<0.001) of their initial weight. At 12 months, all patients had lost >5%, and 67% (4/6) achieved a >10% bodyweight loss. In the course of the study, altered eating patterns were observed. There were no complications with the medical device. Of note, all patients continued to lose weight after the initial intervention period (p<0.001) and none of them had weight regain. With this medical device, overweight and obese patients with a history of previously frustrating attempts to lose weight achieved a significant and sustained weight loss over two years. These results warrant the ongoing prospective randomised controlled trial to prove concept and mechanism of action.
  
  
  BACKGROUND
  German Clinical Trials Register DRKS00011357.
authors.affiliation: Medical Practice, Wiesbaden, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: von Seck
authors.affiliation: Dental Clinic, Frankfurt, Germany.
authors.forename: F Martin
authors.initials: FM
authors.lastname: Sander
authors.affiliation: Department of Health Care Management, Technical University Berlin, Berlin, Germany.
authors.forename: Leon
authors.initials: L
authors.lastname: Lanzendorf
authors.affiliation: MSD SHARP & DOHME GMBH, Berlin, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: von Seck
authors.affiliation: Department of Internal Medicine, Hygiea Hospital and Medical Practice, Berlin, Germany.
authors.forename: André
authors.initials: A
authors.lastname: Schmidt-Lucke
authors.affiliation: Charité University Berlin, Berlin, Germany.
authors.forename: Mirja
authors.initials: M
authors.lastname: Zielonka
authors.affiliation: Charité University Berlin, Berlin, Germany.|Medico-academic Consultings, Berlin, Germany.
authors.forename: Caroline
authors.initials: C
authors.lastname: Schmidt-Lucke
mesh_terms: D001521:Behavior Therapy; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D004035:Diet Therapy / Q000295:instrumentation; D005247:Feeding Behavior; D006801:Humans; D008297:Male; D008409:Mastication; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy*; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome; D015431:Weight Loss