Comprehensive Approach to Family Weight Management

描述（由申请人提供）： 项目概述：本研究的目的是解决健康人群2010肥胖预防目标。本研究将测试一个全面的家庭体重管理计划对BMI > 85百分位数的7-12岁儿童的BMI z评分的影响，这些儿童在大型市政布朗克斯医院接受初级保健。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。一项两组随机对照临床试验（RCT）将入组（n =506）BMI ≥ 85百分位数的7-12岁儿童，并将实验性强化干预与标准（对照）干预进行比较。标准干预将收到：1）初步咨询，其中包括生活方式目标的概述，2）季度随访，3）和每月通讯。强化干预将增加：1）12个核心小组模块，针对父母（解决角色和技能问题）和儿童（提高动机和技能，提供体育活动），3）社区卫生工作者使用工具箱方法提供量身定制的支持，作为家庭体重管理专业教育人员的延伸，以及4）每月核心后续小组。该研究将确定随机分配到实验性强化干预的儿童是否比随机分配到对照标准干预的儿童在BMI变化（z评分）方面有更大的改善。该研究还将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评估将解决：覆盖范围：有多少符合条件的儿童/家庭被转诊，有多少被转诊的儿童/家庭实际入组？我们将使用计算机化医疗记录中的BMI数据来评估转诊的比例和适当性。疗效/有效性：按计划随访时，实验性干预如何影响BMI（z评分变化）和关键生物标志物？采用：初级保健医疗团队和儿科诊所的儿童/家庭等对干预的接受程度如何？(from过程措施和干预后调查）实施：按计划提供了多少干预活动？质量控制措施将用于评价干预措施的完整性。维持：干预效果有多少是可持续的？将根据24个月随访数据评价个体效应。体制效果评价将包括利用第三方保险维持服务的潜力。 项目叙述本研究的目的是解决健康人2010年肥胖预防目标，并在7-12岁超重的布朗克斯儿童中测试全面的家庭体重管理计划。该研究将506名儿童随机分为实验（强化）干预组和标准（对照）干预组。标准干预将收到：1）初步咨询，其中包括生活方式目标的概述，2）季度随访，3）和每月通讯。强化干预将增加：1）12个核心小组模块，供父母（解决角色和技能问题）和儿童（提高动机和技能，提供体育活动）使用，3）社区卫生工作者使用“工具箱”方法提供有针对性的支持，作为家庭体重管理专业教育工作人员的延伸，以及4）每月一次的核心后续小组。

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.