Addressing appetitive traits to promote weight management in children who overeat

摘要 在美国，大约35%的儿童超重或肥胖（OW/OB）。迄今为止，最成功的 儿童减肥计划是以家庭为基础的治疗（FBT），这是交付给儿童和 父母，包括营养和体育活动教育，行为治疗技术，和养育 skills.数据显示，参加FBT的儿童中有2/3没有反应。这种失败表明 有一些未解决的机制可能会影响治疗反应。行为 易感性理论声称食物提示反应（FR）是进食发作的主要驱动力，而 饱腹感反应（SR）是进食抵消的主要驱动力。高FR是影响体重的危险因素 参加FBT的儿童的损失维持。我们开发了一种治疗 OW/OB儿童的行为敏感性被称为线索调节（ROC）， 理论ROC项目针对这些过度饮食的机制，通过专注于减少FR和 增加SR。我们对OW/OB过量饮食的儿童进行了ROC模型的初步测试，结果表明， ROC方案是可行的，可接受的，是一个有前途的治疗儿童。建议的目标 研究是为了进一步评估ROC计划在高FR的OW/OB儿童中的作用， 父母我们建议在加州大学圣地亚哥分校和加州大学洛杉矶分校进行一项多中心4臂随机对照试验。 明尼苏达州，将比较ROC，FBT，ROC+营养教育和热量限制（ROC+）和健康 教育比较（HE）超过18个月。我们将招募280名OW/OB儿童， 高FR及其父母，并将在基线、整个治疗期间、治疗后 以及6个月和12个月随访时。这项研究的主要目的是评估儿童体重的变化 (BMIz/%BMIp95）以及在ROC、FBT、ROC+和HE中登记的儿童中的暴饮暴食事件。 次要目标1将比较ROC、FBT、ROC+和HE对儿童SR、FR、抑制和能量摄入的影响， 治疗过程和随访。次要目标2将比较母体的ROC、FBT、ROC+和HE 结果，包括体重减轻（BMI）、暴饮暴食事件、饱腹感反应、食物提示反应 抑制和能量摄入。最后，探索性目标1将评估 介质（食物提示反应性、饱腹感反应性、抑制）和调节剂（食物提示 反应性、饱腹感反应性、人口统计学、基线BMIz/%BMIp95/BMI）， 随着时间的推移，孩子和父母的体重减轻。这项研究可以提供一个更持久的减肥 该计划适用于OW/OB和高FR儿童，并有可能改变减肥模式 治疗儿童。这项研究也将有助于研究基本的食欲机制和食物 并为OW/OB儿童制定知情临床决策。

ABSTRACT Approximately 35% of children in the U.S. have overweight or obesity (OW/OB). To date, the most successful weight loss program for children is Family-Based Treatment (FBT), which is delivered to both children and parents and includes nutrition and physical activity education, behavior therapy techniques, and parenting skills. Data suggest that 2/3 of children who participate in FBT do not respond. This lack of success suggests that there are unaddressed mechanisms that could be impacting treatment response. The Behavioral Susceptibility Theory purports that food cue responsiveness (FR) is the primary driver of eating onset, while satiety responsiveness (SR) is the primary driver of eating offset. High FR is a risk factor that influences weight loss maintenance among children who participate in FBT. We developed a new model for the treatment of children with OW/OB, called Regulation of Cues (ROC), which is based on the Behavioral Susceptibility Theory. The ROC program targets these mechanisms for overeating, by focusing on reducing FR and increasing SR. We pilot tested the ROC model with children who overeat with OW/OB, and showed that the ROC program is feasible, acceptable and is a promising treatment for children. The objective of this proposed study is to further evaluate the ROC program among children with OW/OB who are high on FR and their parents. We propose a multisite 4-arm randomized controlled trial at UC San Diego and University of Minnesota that will compare ROC, FBT, ROC+ nutrition education and caloric restriction (ROC+) and a health education comparator (HE) over 18 months. We will recruit and randomize 280 children with OW/OB who are high on FR and their parents and will conduct assessments at baseline, throughout treatment, post-treatment, and at 6- and 12-month follow-up. The primary aim of this study is to evaluate changes in child weight (BMIz/%BMIp95) as well as overeating episodes among children enrolled in ROC, FBT, ROC+ and HE. Secondary aim 1 will compare ROC, FBT, ROC+ and HE on child SR, FR, inhibition, and energy intake over the course of the treatment and follow-up. Secondary aim 2 will compare ROC, FBT, ROC+ and HE on parent outcomes, including weight loss (BMI), overeating episodes, satiety responsiveness, food cue responsiveness inhibition, and energy intake over the course of treatment and follow-up. Finally, exploratory aim 1 will evaluate effects of mediators (food cue responsiveness, satiety responsiveness, inhibition) and moderators (food cue responsiveness, satiety responsiveness, demographics, baseline BMIz/%BMIp95/BMI) of treatment effects on weight loss over time among children and parents. This study could provide a more durable weight loss program for children with OW/OB and high FR and has the potential to change the paradigm of weight-loss treatment for children. This study will also contribute to the study of basic appetitive mechanisms and food intake and inform clinical decision making for children with OW/OB.