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

描述（由申请人提供）：以家庭为基础的治疗（FBT）是一种行为体重控制干预措施，针对超重/肥胖儿童及其父母，并有能力改善非目标家庭成员（如兄弟姐妹）的体重状况。在长达10年的随访中，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强有力的关系。FBT的同时照顾两代肥胖的家庭是更有效和成本效益比，如果家庭成员是由他们单独的医疗保健提供者。尽管FBT的疗效得到了认可，但它主要在专科诊所提供，许多儿童未能接受基于指南的FBT治疗。 美国预防服务工作组建议的治疗水平。初级保健提供了一个最佳的设置提供FBT利用初级保健提供者和家庭之间建立的关系。在初级保健环境中共同使用干预人员克服了护理分散以及缺乏提供者时间和培训所造成的障碍。将儿童肥胖症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，体育活动和行为改变信息很快，而其他人学习得较慢。由于个体差异，个体在执行治疗建议的能力方面也有所不同，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型来适应这些个体差异，其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一致。这项多中心临床试验旨在评价一年内由一名训练有素的干预人员在初级保健中提供的FBT+初级保健提供者提供的增强型常规护理（FBT+EUC）与单独的增强型常规护理（EUC）相比的有效性。参与者将是528个家庭的代表性样本，其中有一个6-12岁的孩子和一个超重/肥胖的父母。还将研究大约228名超重/肥胖且年龄在2-18岁之间的兄弟姐妹的体重变化。本研究将测试儿童（小学特定） 目标1A）和母公司（主要特定目标1B）体重变化，以及超重/肥胖兄弟姐妹的体重变化（次要目标1），父母和孩子延迟满足的变化，以及延迟满足的变化如何与父母和孩子的体重变化相关（次要目标2），治疗成功的参与者水平预测因素（次要目标3），以及提供者对循证治疗的态度和对FBT的看法如何与他们未来在实践中使用共定位FBT的意图相关（探索性目标1）。确定FBT可以在真实的世界环境中有效实施，对于创建一个系统至关重要，通过该系统，患有肥胖症的儿童及其家庭可以在集中的初级保健环境中得到治疗。

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.