Comprehensive Approach to Family Weight Management

描述(由申请人提供)： 项目概述：本研究的目的是为了解决2010年健康人群肥胖预防目标。这项研究将测试全面的家庭体重管理计划对在布朗克斯一家大型市政医院接受初级保健的7-12岁BMI&GT；85%儿童的BMI z得分的影响。干预框架将借鉴社会营销理论和行为改变的跨理论模型，纳入成功的肥胖预防策略。一项双臂随机对照临床试验(RCT)将纳入(n=506)7-12岁体重指数为第85百分位数的儿童，将比较试验性强化干预和标准(对照)干预。标准干预将收到：1)初始咨询，其中包括生活方式目标的概述，2)季度随访，3)和每月一次的时事通讯。密集干预将增加：1)为家长(处理角色和技能)和儿童(增强动力和技能以及提供体力活动)提供12个核心小组单元，3)使用社区卫生工作者作为家庭体重管理专业教育人员的延伸的工具箱方法提供量身定制的支持，以及4)每月核心后后续小组。这项研究将确定随机接受实验强化干预的儿童是否会比随机接受对照标准干预的儿童在体重指数变化(z-Score)方面有更大的改善。这项研究还将评估实验性干预对生活方式变量的影响，并评估干预成本。RE-AIM评估将涉及：REACH：有多少符合条件的儿童/家庭被转介，有多少被转介的儿童/家庭实际入学？我们将使用电脑化医疗记录中的BMI数据来评估转介的比例和适当性。有效性/有效性：实验干预如何影响BMI(z分数的变化)，以及按计划进行跟踪时的关键生物标记物？采用：初级保健医疗队和儿科诊所的儿童/家庭等接受干预措施(S)的程度如何？(来自过程措施和干预后调查)执行情况：按计划提供了多少干预活动？将使用质量控制措施来评估干预措施的完整性(S)。维护：干预效果在多大程度上是可持续的？个人效果将根据24个月的跟踪数据进行评估。机构效果评估将包括利用第三方覆盖范围维持服务的可能性。 项目简介这项研究的目的是解决2010年健康人肥胖预防目标，并在7-12岁的布朗克斯超重儿童中测试全面的家庭体重管理计划。这项研究将506名儿童随机分为试验性(强化)干预组或标准(对照)干预组。标准干预将收到：1)初始咨询，其中包括生活方式目标的概述，2)季度随访，3)和每月一次的时事通讯。密集干预将增加：1)为父母(处理角色和技能)和儿童(增强动力和技能，并提供体力活动)提供12个核心小组单元；3)利用社区卫生工作者的“工具箱”方法，作为家庭体重管理专业教育人员的延伸，提供量身定制的支助；以及4)每月核心后后续小组。

DESCRIPTION (provided by applicant): Project Summary: The purpose of this study is to address the Healthy People 2010 obesity prevention objective. This study will test the effects of a comprehensive family weight management program on the BMI z-score of 7-12 year-old children with a BMI > 85th percentile who receive primary care in a large municipal Bronx hospital. The intervention framework will draw on social marketing theory and the transtheoretical model of behavioral change to incorporate successful obesity prevention strategies. A two-arm randomized controlled clinical trial (RCT), which will enroll (n =506) 7-12 year old children with a = 85th BMI percentile, will compare the Experimental Intensive Intervention to a Standard (Control) Intervention. The Standard Intervention will receive: 1) an initial consult, which includes an overview of lifestyle goals, 2) quarterly follow-up, 3) and a monthly newsletter. The Intensive Intervention will add: 1)12 core group modules for parents (to address roles and skills) and for children (to enhance motivation and skills and to provide physical activity), 3) Tailored support using a }toolbox} approach from community health workers as extensions of the Family Weight Management professional education staff, and 4) monthly after-core follow-up groups. The study will determine if children randomized to the Experimental Intensive Intervention will have greater improvement in BMI change (z-scores) than those randomized to the Control Standard Intervention. The study will also evaluate the effects on the Experimental Intervention on lifestyle variables and assess intervention costs. The RE-AIM evaluation will address: Reach: How many of the eligible children/ families were referred and how many of those referred actually enrolled? We will use BMI data in the computerized medical records to evaluate the proportion and the appropriateness of the referrals. Efficacy/Effectiveness: How did the Experimental intervention affect BMI (changes in z-score), and key biomarkers when followed as planned? Adoption: How acceptable were the intervention(s) to the primary care medical team and the children/families in the pediatric clinics etc? (from process measures and post intervention surveys) Implementation: How many of the intervention activities were provided as planned? Quality control measures will be used to evaluate the integrity of the intervention(s). Maintenance: How much of the intervention effect is sustainable? Individual effects will be evaluated based on the 24 month follow data. Institutional effects evaluation will include the potential to maintain services using third-party coverage. Project Narrative The purpose of this study is to address the Healthy People 2010 obesity prevention objective and to test a comprehensive family weight management program in 7-12 year- old Bronx children who are overweight. The study will randomize 506 children to the Experimental (Intensive) Intervention or to a Standard (Control) Intervention. The Standard Intervention will receive: 1) an initial consult, which includes an overview of lifestyle goals, 2) quarterly follow-up, 3) and a monthly newsletter. The Intensive Intervention will add: 1)12 core group modules for parents (to address roles and skills) and for children (to enhance motivation and skills and to provide physical activity), 3) tailored support using a "toolbox" approach from community health workers as extensions of the Family Weight Management professional education staff, and 4) Monthly after-core follow-up groups.