Treatment of obesity targeting appetite and cue reactivity

 描述（由申请人提供）：每三个成年人中就有两个超重或肥胖。超重和肥胖与显著的医学和心理共病相关。迄今为止，最成功的减肥治疗是行为减肥（BWL），其中包括营养和体育活动教育，以及行为治疗技术。虽然许多成年人在这些项目中减肥，但研究表明，三分之一到一半的人没有反应。此外，对于那些减肥的人来说，减肥维持成为一个重大的挑战。我们开发了一种新的治疗肥胖的模型，称为线索调节（ROC），它是基于Schachter的外部性理论。ROC计划针对Schachter理论中暴饮暴食的两种理论化机制;对食欲线索的敏感性降低和对外部食物线索的敏感性增加。我们已经在一项试点试验中对ROC模型进行了测试，其中超重成人暴饮暴食。我们的初步数据显示，参与者在治疗期间显著降低了BMI，并在治疗后三个月的时间点继续降低BMI。这项研究的目的是进一步评估ROC计划与超重和肥胖的成年人。考虑到BWL对某些人有好处，但无法促进维持，我们提出了一项4臂随机对照试验，将比较ROC，BWL，ROC+BWL组合和注意力控制（AC）。我们将招募并随机分配280名超重/肥胖成人，并在基线、治疗中期（第6个月）、治疗后（第12个月）、中期随访（第18个月）和随访（第24个月）时对其进行评估。主要和次要目标如下。主要目的1：在治疗过程和随访期间，比较ROC和ROC+BWL与AC在体重指数（BMI）、身体成分和暴饮暴食方面的差异。主要目的2：比较ROC和ROC+BWL与BWL在治疗过程和随访期间的体重指数（BMI）、身体成分和暴食方面的差异。次要目标1：比较ROC、ROC+BWL、BWL和AC在治疗和随访期间对食欲线索敏感性、对食物线索敏感性、抑制、限制、热量摄入、暴饮暴食和体力活动的影响。探索性目标1：在每个治疗组中评估BMI随时间变化的中介因素（对食欲线索的敏感性，对食物线索的敏感性，抑制，限制，暴饮暴食，对食物线索的过度饮食）和调节因素（人口统计学，基线BMI，暴饮暴食状态）。这项研究计划是超重和肥胖人群治疗发展的重要下一步，可能会改变肥胖治疗的范式。这项研究将有助于研究基本的行为机制和食物摄入量，可以提供一个新的模型，治疗肥胖，并可以告知临床决策有关肥胖治疗。

 DESCRIPTION (provided by applicant): Two out of every three adults is overweight or obese. Overweight and obesity is associated with significant medical and psychological comorbidities. To date, the most successful weight loss treatment is behavioral weight loss (BWL), which includes nutrition and physical activity education, as well as behavior therapy techniques. Although many adults lose weight in these programs, studies suggest that one third to one half do not respond. Additionally, for those who do lose weight, weight loss maintenance becomes a significant challenge. We have developed a new model for the treatment of obesity, called Regulation of Cues (ROC), which is based on Schachter's Externality Theory. The ROC program targets two theorized mechanisms for overeating in Schachter's Theory; decreased sensitivity to appetitive cues and increased sensitivity to external food cues. We have tested the ROC model with overweight adults who binge eat in a pilot trial. Our initial data showed that participants significantly decreased their BMI during treatment and continued to decrease their BMI at the three month post-treatment time-point. The objective of this proposed study is to further evaluate the ROC program with overweight and obese adults. Considering that BWL has merit for some people, but fails to facilitate maintenance, we propose a 4 arm randomized controlled trial that will compare ROC, BWL, ROC+BWL combined and an attentional control (AC). We will recruit and randomize 280 overweight/obese adults and will assess them at baseline, mid-treatment (month 6), post-treatment (month 12), mid-follow-up (month 18) and follow-up (month 24). Primary and secondary aims are as follows. Primary Aim 1: Compare ROC and ROC+BWL to AC on body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. Primary Aim 2: Compare ROC and ROC+BWL to BWL on body mass index (BMI), body composition, and binge eating over the course of treatment and follow-up. Secondary Aim 1: Compare ROC, ROC+BWL, BWL and AC on sensitivity to appetitive cues, sensitivity to food cues, inhibition, restriction, caloric intake, overeating, and physical activity over the course of the treatment and follow-up. Exploratory aim 1: Evaluate mediators (sensitivity to appetitive cues, sensitivity to food cues, inhibition, restriction, binge eating, overeating in response to food cues) and moderators (demographics, baseline BMI, binge eating status) on BMI over time in each treatment arm. This program of research is an important next step in the development of treatments for overweight and obese people, and could change the paradigm of obesity treatment. This study will contribute to the study of basic behavioral mechanisms and food intake, could provide a novel model for the treatment of obesity, and could inform clinical decision making regarding obesity treatment.