Department of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA; Department of Family Medicine and Public Health, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA; Department of Psychiatry, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA.
Department of Pediatrics, University of California San Diego, 9500 Gilman Drive, La Jolla, CA 92037, USA.
Contemp Clin Trials. 2019 Sep;84:105824. doi: 10.1016/j.cct.2019.105824. Epub 2019 Aug 7.
The majority of adults in the United States have overweight or obesity which is associated with significant health and psychological consequences. Behavioral Weight Loss (BWL) is the current gold-standard weight-loss program for adults but recidivism rates continue to be disturbingly high. Given the health consequences of excess weight and the lack of long-term effectiveness of BWL, it is important to identify novel weight-loss programs. We developed the ROC (Regulation of Cues) program to reduce overeating through improvement in sensitivity to appetitive cues and decreased responsivity to external food cues. This study is a 4-arm randomized control trial designed to evaluate the efficacy of ROC, ROC combined with BWL, BWL alone and an active comparator over 24 months. Study recruitment completed in November 2017. Two hundred and seventy-one participants were randomized (mean age = 46.97 years; 82% female, mean BMI = 34.59; 20% Hispanic) and assessments were conducted at baseline, mid-treatment (6 months) and post-treatment (12 months). At this time, participants are completing 6- (18 months) and 12-month (24 months) follow-ups. Targeting novel mechanisms is critically important to improve weight-loss programs. Through this trial, we hope to identify treatments for adults with overweight and obesity to facilitate long-term weight loss and improved health.
美国大多数成年人超重或肥胖，这与严重的健康和心理后果有关。行为体重减轻（BWL）是目前成年人减肥的黄金标准方案，但复发率仍然高得令人不安。鉴于超重的健康后果和 BWL 的长期效果缺乏，确定新的减肥方案很重要。我们开发了 ROC（线索调节）程序，通过提高对食欲线索的敏感性和降低对外界食物线索的反应性来减少暴饮暴食。这项研究是一项四臂随机对照试验，旨在评估 ROC、ROC 与 BWL 联合、BWL 单独和活性对照物在 24 个月内的疗效。研究招募于 2017 年 11 月完成。271 名参与者被随机分组（平均年龄 46.97 岁；82%为女性，平均 BMI 为 34.59；20%为西班牙裔），并在基线、治疗中期（6 个月）和治疗后（12 个月）进行评估。此时，参与者正在进行 6 个月（18 个月）和 12 个月（24 个月）的随访。针对新的机制至关重要，这有助于改善减肥方案。通过这项试验，我们希望为超重和肥胖的成年人确定治疗方法，以促进长期减肥和改善健康。
