The Effectiveness of Family-based Weight Loss Treatment Implemented in Primary Care - CCC - Lead Application

描述(申请人提供)：基于家庭的治疗(FBT)是一种行为体重控制干预措施，目标是超重/肥胖的儿童及其父母，并有能力改善非目标家庭成员的体重状况，如兄弟姐妹。在长达10年的跟踪调查中，FBT对儿童的体重有显著的积极影响，并且在儿童和父母的结果之间观察到了牢固的关系。FBT在家庭中同时照顾两代肥胖患者比由他们各自的医疗保健提供者治疗家庭成员更有效和更具成本效益。尽管FBT的有效性得到了认可，但FBT主要在专科诊所提供，许多儿童无法获得这种基于指南的治疗 治疗水平，由美国预防服务工作组建议。初级保健通过利用初级保健提供者和家庭之间已建立的关系，为FBT的提供提供了最佳的环境。在初级保健环境中使用共同安置的干预者克服了保健分散以及缺乏提供人员的时间和培训所造成的障碍。将儿童肥胖治疗纳入初级保健的挑战之一是优化有限的卫生保健资源。在行为减肥计划中，一些人学习饮食、体力活动和行为变化的信息很快，而另一些人学习得更慢。由于个体差异，个体执行治疗建议的能力也不同，例如延迟满足的问题。FBT通过使用个性化的指导系统或掌握模式来适应这些个体差异，在这种模式中，治疗的内容和剂量根据家庭的需要进行校准，确保治疗努力与需要保持一致。这项多点临床试验旨在评估在一到一年的时间内，由一名训练有素的干预者在初级保健内共同提供的FBT加上初级保健提供者提供的增强型常规护理(FBT+EUC)与单独加强常规护理(EUC)相比的有效性。参与者将是具有代表性的528个家庭的样本，这些家庭有一个6-12岁的孩子，父母都超重/肥胖。还将研究大约228名超重/肥胖和2-18岁之间的兄弟姐妹的体重变化。本研究将检验两组儿童之间的差异(小学生 目标1)和父母(主要目标1B)的体重变化，以及超重/肥胖兄弟姐妹的体重变化(次要目标1)，父母和孩子满足延迟的变化，延迟满足的变化与父母和孩子体重变化的关系(次要目标2)，参与者对治疗成功的预测因素(次要目标3)，以及提供者对循证治疗的态度和对FBT的看法可能如何与他们在未来的实践中使用同一地点的FBT的意向有关(探索性目标1)。确定可以在现实世界环境中有效地实施FBT，对于建立一个系统，使患有肥胖症的儿童及其家庭能够在集中的初级保健环境中得到治疗至关重要。

DESCRIPTION (provided by applicant): Family-based treatment (FBT) is a behavioral weight control intervention that targets children who are overweight/obese and their parents, and has the capacity to improve the weight status of non-targeted family members such as siblings. FBT has significant positive effects on body weight in children for up to 10-years of follow-up, and a robust relationship is observed between child and parent outcomes. FBT's concurrent care of two generations of obesity in the family is more efficacious and cost-effective than if family members are treated by their separate health care providers. Despite its recognized efficacy, FBT is mainly available in specialty clinics and many children fail to receive this guideline-based level of treatment, as recommended by the U.S. Preventive Services Task Force. Primary care offers an optimal setting for delivery of FBT by capitalizing on the established relationship between primary care providers and families. Using interventionists co-located within the primary care setting overcomes barriers posed by fragmentation of care, and lack of provider time and training. One of the challenges to integrating childhood obesity treatment into primary care is optimizing limited health care resources. In behavioral weight loss programs, some individuals learn diet, physical activity, and behavior change information quickly, while others learn more slowly. Individuals also differ in their ability to implement treatment recommendations due to individual differences, such as problems with delaying gratification. FBT accommodates these individual differences by using a personalized system of instruction, or a mastery model, in which the content and dose of treatment is calibrated to the needs of the family, ensuring that treatment effort is consistent with need. This multi-site, clinical trial aims to evaluate over a to year period the effectiveness of FBT delivered by a trained interventionist co-located within primary care plus enhanced usual care delivered by the primary care provider (FBT+EUC) compared to enhanced usual care alone (EUC). Participants will be a representative sample of 528 families with a 6-12 year-old child and a parent who are both overweight/obese. Weight changes in approximately 228 siblings who are overweight/obese and between 2-18 years of age will also be studied. This study will test between group differences in child (Primary Specific Aim 1A) and parent (Primary Specific Aim 1B) weight change, as well as weight change in siblings who are overweight/obese (Secondary Aim 1), changes in parent and child delay of gratification, and how changes in delay of gratification are related to parent and child weight changes (Secondary Aim 2), participant level predictors of treatment success (Secondary Aim 3), and how provider attitudes toward evidence-based treatment and perceptions of FBT may relate to their intention to use co- located FBT in their practices in the future (Exploratory Aim 1). Establishing that FBT can be effectively implemented within real world settings is crucial to creating a system by which children and their families who suffer from obesity can be treated in a centralized primary care setting.