Clinic, Family & Community Collaboration to Treat Overweight and Obese Children

描述（由申请人提供）： 我们提出了一种创新的、综合的、多成分的、多水平的、多环境的（MMM）方法来治疗超重和肥胖儿童（BMI > 85百分位）。实验性MMM干预是基于过去成功的研究和正在进行的社区参与性研究（CBPR），旨在克服现有治疗模式的障碍。它包括：一个基于理论的社区中心团队运动计划，专门为超重和肥胖儿童设计;一个以家庭为基础的家庭干预，以减少屏幕时间和改变家庭食物/饮食环境;和一个初级保健提供者行为咨询干预与社区和家庭干预。经过两年的形成性研究和试点研究，我们将在随机对照试验中评估我们的干预措施。将通过初级保健儿科诊所招募240个超重和肥胖儿童家庭，这些诊所为加州东帕洛阿尔托和红杉城的低收入、种族多样化的患者人群提供服务。符合条件的参与者将由他们的初级医疗保健提供者转介到当地基督教青年会和男孩女孩俱乐部进行的课后计划。在完成基线评估并参加研究后，家庭将被随机分配到标准临床护理和标准社区中心计划，或实验性MMM干预36个月。所有参与者将在基线、12个月、24个月和36个月时完成评估。主要结果指标是整个研究过程中BMI的变化。次要结局包括12个月和24个月的变化，腰围、三头肌皮褶厚度、血压、心率、空腹脂蛋白水平、葡萄糖和胰岛素、hsCRP、体力活动（加速计）、屏幕时间和其他久坐行为、饮食摄入、体重问题和抑郁症状的变化。将收集DNA以确定干预反应性的遗传调节因子。我们将使用随机回归模型比较MMM干预组和标准护理对照组，以充分利用所有纵向数据。主要假设：与标准护理对照组相比，随机分配到我们的多组分、多水平、多设置（MMM）干预组的儿童将显著降低他们的体重指数。我们还将研究潜在的基线生物，心理，社会和环境调节和中介变量，成本效益和公共政策的影响。

DESCRIPTION (provided by applicant): We propose an innovative, integrated, multi-component, multi-level, multi-setting (MMM) approach to treating overweight and obese children (BMI > 85th percentile). The experimental MMM intervention is based on successful past research and ongoing community based participatory research (CBPR), and is designed to overcome barriers to existing treatment models. It includes: a theory-based community center team sports program designed specifically for overweight & obese children; a home-based family intervention to reduce screen time and to alter the home food/eating environment; and a primary care provider behavioral counseling intervention linked to the community and home interventions. After two years of formative research and pilot studies, we will evaluate our intervention in a randomized controlled trial. 240 families with overweight and obese children will be recruited through primary care pediatric clinics serving low-income, ethnically-diverse patient populations in East Palo Alto and Redwood City, California. Eligible participants will be referred by their primary medical care providers to after school programs conducted by their local YMCAs and Boys and Girls Clubs. After completing baseline assessments and enrolling in the study, families will be randomized to standard clinical care and the standard community center programs, or to the experimental MMM intervention for 36 months. All participants will complete assessments at baseline, 12 months, 24 months and 36 months. The primary outcome measure is change in BMI over the entire course of the study. Secondary outcomes include changes to 12 and 24 months, and changes in waist circumference, triceps skinfold thickness, blood pressures, heart rate, fasting lipoprotein levels, glucose and Insulin, hsCRP, physical activity (accelerometery), screen time and other sedentary behaviors, dietary intake, weight concerns, and depressive symptoms. DNA will be collected to identify genetic moderators of intervention responsiveness. We will compare the MMM intervention and standard care control groups using random regression models to take full advantage of all longitudinal data. Primary Hypothesis: Compared to standard care controls, children randomized to our multi-component, multi-level, multi-setting (MMM) intervention will significantly reduce their body mass index. We will also examine potential baseline biological, psychological, social and environmental moderating and mediating variables, cost-effectiveness and public policy implications.