Effect of Treatment Dose on Childhood Obesity

 描述（由申请人提供）：每三个孩子中就有一个超重或肥胖。儿童期超重和肥胖与儿童和成人的健康和心理社会不良后果有关。迄今为止，对超重或肥胖儿童最成功的减肥治疗是以家庭为基础的行为计划（FBT），这些计划在6个月的时间内在单独的父母和儿童小组中进行。FBT是相当密集的，获得这些方案可能是具有挑战性的。我们开发了一种基于FBT（gshFBT）的指导性自助治疗，并向父母和儿童提供自助手册，沿着指导，每隔一周进行20分钟的检查。我们的研究表明，gshFBT是可行的，家庭可以接受的，与延迟治疗对照相比，它降低了儿童和父母的体重，并且与更密集的FBT相比，它产生了类似的体重减轻。然而，我们所有的gshFBT研究都是在85%BMI-98%BMI的儿童中进行的，到目前为止，这种方法还没有在体重较重的儿童中进行过测试。此外，我们的初步研究仅包括6个月的随访时间点，需要更长的随访时间。因此，本研究的目的是进行一项充分把握度的随机对照试验，在超重和肥胖体重范围内的儿童中比较gshFBT与FBT。我们将招募、随机化和治疗160名超重/肥胖儿童及其父母，并在基线、治疗后以及6个月和18个月随访时对他们进行评估。主要和次要目标如下。主要目的1：比较gshFBT和FBT在两年研究中对目标儿童体重的影响。主要目的2：评价gshFBT与FBT相比的成本效益。次要目标1：确定gshFBT和FBT影响父母BMI、育儿技能以及父母和孩子身体活动和饮食摄入的程度。此外，作为探索性目标，我们将评估gshFBT和FBT的调节者和调解者，包括执行功能和父母教养方式。这一应用是开发超重和肥胖儿童治疗方法的关键下一步，可以提供一种强度较低、成本较低的治疗方法，并有可能提供给更大比例的人群。

 DESCRIPTION (provided by applicant): One in every three children is overweight or obese. Overweight and obesity in childhood is associated with negative health and psychosocial consequences for children and adults. To date, the most successful weight loss treatment for children who are overweight or obese are family-based behavioral programs (FBT) that are delivered in separate parent and child groups over a 6-month period. FBT is fairly intensive and access to these programs can be challenging. We have developed a guided self-help treatment which is based on FBT (gshFBT), and provides a self-help manual to parents and children along with guidance in the form of 20-minute check-in visits every other week. Our studies show that gshFBT is feasible and acceptable to families, decreases body weight in children and parents compared to a delayed treatment control, and that it produces similar weight losses compared to the more intensive FBT. However, all of our studies with gshFBT were conducted with children who were 85%BMI-98%BMI and to date, this method has not been tested with heavier children. Additionally, our pilot studies only included a 6-month follow-up timepoint and longer follow-up is needed. Thus, the objective of this study is to conduct a fully powered randomized controlled trial comparing gshFBT with FBT in children across the overweight and obese weight spectrum. We will recruit, randomize and treat 160 overweight/obese children and their parents and assess them at baseline, post-treatment, and 6- and 18-months follow-up. Primary and secondary aims are as follows. Primary Aim 1: Compare the effect of gshFBT and FBT on the target child's weight over the two years of the study. Primary Aim 2: Evaluate the cost effectiveness of gshFBT as compared to FBT. Secondary Aim 1: Determine the extent to which the gshFBT and FBT affects parent BMI, parenting skills, and parent and child physical activity and dietary intake. Additionally, as exploratory aims, we will evaluate moderators and mediators of gshFBT and FBT including executive functioning and parenting style. This application is a critical next step in the development of treatments for overweight and obese children, and could provide a treatment that is less intensive, less costly and has the potential to be provided to a larger proportion of the population.