Persistent weight loss with a non-invasive novel medical device to change eating behaviour in obese individuals with high-risk cardiovascular risk profile

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.
Trial registration: German Clinical Trials Register DRKS00011357

在循证减肥方案中，体重初始下降后常出现体重反弹。细嚼慢咽可显著降低一餐的能量摄入及饥饿感评分。尽管已有此认知，但肥胖人群并未践行这一行为。因此，我们开展研究以验证假说：通过口腔内医用装置（intra-oral medical device）改变进食行为，可使超重及肥胖人群实现持续的体重下降。

本前瞻性研究纳入6例肥胖患者（均为男性，年龄56±14岁，体质量指数（BMI）29±2 kg/m²），均合并心血管危险因素谱异常。所有患者均于近10年间在单中心接受过肥胖治疗，且至少3次尝试循证饮食但均以失败告终。患者被置入一款新型无创口腔内医用装置，以延长进食时长。研究同时给予患者如下指导：无需计算热量摄入、避免采用其他任何节食方式、从容用餐且可自由选择食物。

该装置仅需在进餐时段使用，初始干预周期为4至8周，总使用时长为88[20–160]小时。随访周期为23[15–38]个月。随访期间，患者体重较基线下降11%[5%–20%]（p<0.001）。随访至12个月时，所有患者体重下降幅度均超过5%，其中67%（4/6）的患者体重下降超过10%。研究过程中观察到患者进食模式发生改变。该医用装置未出现任何并发症。值得注意的是，初始干预结束后，所有患者仍持续出现体重下降（p<0.001），且无一例出现体重反弹。

借助该医用装置，既往减肥尝试均以失败告终的超重及肥胖患者实现了两年以上的显著且持续的体重下降。本研究结果支持开展后续前瞻性随机对照试验，以验证该装置的作用概念与作用机制。

试验注册：德国临床试验注册库（German Clinical Trials Register）DRKS00011357