Clinical/Behavioral Approach to Overweight Latino Youth

描述(申请人提供)：超重和肥胖是墨西哥裔美国儿童的一个严重问题，部分原因是贫困、文化适应、遗传易感性或其他因素。基于临床的体重控制研究显示出了希望，但通常包括很少或没有拉丁裔儿童的方便样本。这项随机对照试验将对390名超重的6-9岁墨西哥裔美国儿童进行循证干预的有效性进行测试，这些儿童来自一家大型(36,192名儿科患者)社区诊所，为美国-墨西哥边境社区(加利福尼亚州圣伊西德罗)的低收入和中等收入家庭提供服务。干预和测量的设计和选择是基于“拉丁裔健康促进的社会生态学模型”。69名儿童及其父母将被随机分配到特殊干预(SI)组或普通护理(UC)组。SI小组将根据预防+和结构性体重管理方法1参加以下行为改变活动：(1)提供关于健康饮食、增加体力活动、减少久坐行为和有效养育行为的文化敏感健康教育的课程，以模范和加强儿童的健康行为，指导如何改变家庭环境的社会和结构方面，以及如何驾驭社区资源的技能培养；(2)由健康教育者和中层提供者(MLP)进行的集体临床访问(GCV)；(3)与初级保健提供者(PCP)的家庭访问；(4)向家庭提供社区资源的时事通讯；以及(5)通过电话加强目标设定。UC组将接受社区诊所已经提供的针对儿童肥胖的标准健康教育。这项研究的主要结果是儿童BMI，与身体结果、儿童健康行为和育儿行为的其他变化一起，将在四个时间点(基线、6个月、12个月和18个月)进行评估。基本假设是，在6个月干预结束时，SI组的平均BMI低于UC组，最大差异出现在12个月，并将在另外6个月(基线后18个月)保持这种差异。次要目标包括检查干预对儿童能量平衡、体力活动水平、久坐行为和与儿童健康行为相关的父母策略的影响。这项提案是在先前的积极评价之后进行修订的。针对审查和其他改进的变化包括增加了电子家居设备测量的有效性/可靠性信息、完整的传播计划、初步研究的结果数据、队列保留策略的描述、澄清了处理统计建模的意图、纳入了结构方程建模、协查人员的努力水平增加、基本结果(儿童体重指数)的一致描述、样本教材和教学理念的描述、临床访问收入的估计以及减少潜在参与者强迫参加研究的程序。

DESCRIPTION (provided by applicant): Overweight and obesity is a serious problem for Mexican-American children, due in part to poverty, acculturation, genetic predisposition or other factors. Clinic-based weight control studies have shown promise, but often include convenience samples with few or no Latino children. This randomized controlled trial will test the efficacy of a culturally and linguistically appropriate, evidence-based intervention to lower Body Mass Index (BMI) or slow weight gain among 390 overweight 6-9 year old Mexican-American children randomly sampled from a large (36,192 pediatric patients) community clinic providing services to low and medium income families in a US-Mexico border community (San Ysidro, CA). Intervention and measurement design and selection are based on a "Socioecological Model for Latino Health Promotion". 69 Children and their parents will be randomly assigned to either a Special Intervention (SI) or Usual Care (UC) group. The SI group will participate in the following behavior change activities based on Prevention Plus and Structured Weight Management approaches 1 : (1) classes providing culturally-sensitive health education regarding healthy eating, increasing physical activity, decreasing sedentary behaviors, and effective parenting behaviors to model and reinforce children's health behaviors, instruction on how to modify both social and structural aspects of the home environment, and skills-building to navigate community resources; (2) group clinical visits (GCV) with a Health Educator and Mid-Level Provider (MLP); (3) family visits with primary care providers (PCP); (4) newsletters to refer families to community resources; and (5) phone calls to reinforce goal setting. The UC group will receive standard health education for childhood obesity already provided by the community clinic. The primary outcome for the study is child BMI, which along with other changes in physical outcomes, child health behaviors and parenting behaviors will be evaluated at four time-points (baseline, 6-, 12-, and 18-months). The primary hypothesis is that the SI group will demonstrate lower mean BMI than the UC group at the end of a 6 month intervention with a maximum difference occurring at 12 months, and will sustain this difference for an additional six months (18 months after baseline). Secondary aims include examining intervention effects on children's energy balance, physical activity levels, sedentary behavior and parenting strategies related to their children's health behaviors. This proposal is revised following a previous positive review. Changes in response to the review and other improvements include the addition of validity/reliability information for measures of electronic home devices, a complete dissemination plan, outcome data for preliminary studies, description of cohort retention strategies, clarification of intention to treat statistical modeling, inclusion of Structural Equation Modeling, increased effort level of co-investigators, consistent delineation of primary outcome (child BMI), sample teaching materials and description of teaching philosophy, estimates of clinic visit revenues, and procedures to reduce potential participant coercion to enroll in the study.