Comprehensive Approach to Family Weight Management

项目摘要 这项研究的目的是为了解决2010年健康人群肥胖的预防问题 目标。这项研究将测试全面的家庭体重管理的效果 关于7-12岁体重指数第85百分位数的儿童的BMI z得分的计划 布朗克斯市一家大型医院的初级保健服务。干预框架将借鉴社会 市场营销理论和行为改变的跨理论模型 肥胖症预防策略。一项双臂随机对照临床试验(RCT)，将 招募(n=506)体重指数第85百分位数的7-12岁儿童，将比较 试验性强化干预转变为标准(对照)干预。标准 干预措施将收到：1)初始咨询，其中包括生活方式目标的概述，2) 每季度跟进一次，每月一份时事通讯。强化干预将增加：1)12个核心 针对家长(处理角色和技能)和儿童(增强积极性)的小组模块 和技能，并提供体力活动)，3)使用工具箱方法提供量身定做的支持 社区卫生工作者是家庭体重管理专业人员的延伸 教育人员，以及4)每月核心后跟进小组。这项研究将确定儿童是否 随机到试验性强化干预将对BMI有更大的改善 改变(z-分数)比随机到对照标准干预的那些。这项研究将 也评估实验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 转介了儿童/家庭，其中有多少儿童/家庭实际入学？我们将使用 在计算机化的病历中评估BMI数据的比例和 转介的适当性。有效性/有效性：实验是如何 干预会影响BMI(z-Score的变化)，以及按计划进行的关键生物标志物吗？ 采用：干预措施(S)对初级保健医疗队和 儿科诊所的儿童/家庭等？(来自过程措施和事后干预 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？个别影响将是 根据24个月的跟踪数据进行评估。机构效果评估将包括 使用第三方覆盖来维护服务的潜力。项目叙事 这项研究的目的是为了解决2010年健康人群肥胖的预防问题 目标并在7-12年内测试全面的家庭体重管理计划- 布朗克斯区超重的老孩子。这项研究将把506名儿童随机分配到 试验性(强化)干预或标准(对照)干预。这个 标准干预将收到：1)初始咨询，其中包括概述 生活方式目标，2)季度跟踪，3)和每月时事通讯。集约化 干预措施将增加：1)为家长提供12个核心小组模块(以解决角色和技能) 对于儿童(增强动力和技能并提供体力活动)，3) 使用来自社区卫生工作者的工具箱方法提供量身定制的支持 扩展家庭体重管理专业教育人员，以及4) 每月核心后跟进小组。

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.