Clinical/Behavioral Approach to Overweight Latino Youth

超重和肥胖是墨西哥裔美国儿童的严重问题，部分原因是贫困，文化适应，遗传倾向或其他因素。基于诊所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在390名超重的6-9岁墨西哥裔美国儿童中测试一种文化和语言上适当的循证干预措施降低体重指数（BMI）或减缓体重增加的有效性，这些儿童是从一家大型（36，192名儿科患者）社区诊所随机抽样的，该诊所为美墨边境社区（加利福尼亚州圣伊西德罗）的中低收入家庭提供服务。干预和测量的设计和选择是基于“拉丁美洲健康促进的社会生态模型”。69名儿童及其父母将被随机分配到特殊干预（SI）组或家庭护理（UC）组。SI小组将参与以下基于预防+和结构化体重管理方法1的行为改变活动：（1）提供关于健康饮食、增加体育活动、减少久坐行为和有效育儿行为的文化敏感健康教育课程，以塑造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，以及技能建设，以浏览社区资源;（2）与健康教育工作者和中层提供者（MLP）进行小组临床访问（GCV）;（3）与初级保健提供者进行家庭探访;（4）向家庭介绍社区资源的通讯;以及（5）加强目标设定的电话。UC组将接受社区诊所已经提供的儿童肥胖标准健康教育。该研究的主要结果是儿童BMI，将在四个时间点（基线，6个月，12个月和18个月）与身体结果，儿童健康行为和养育行为的其他变化沿着进行评估。主要假设是，在6个月干预结束时，SI组的平均BMI将低于UC组，最大差异发生在12个月时，并将在另外6个月（基线后18个月）内维持该差异。次要目的包括研究干预对儿童能量平衡、身体活动水平、久坐行为和与儿童健康行为相关的父母策略的影响。这一建议是在先前的积极审查之后修订的。对审查的响应变化和其他改进包括增加了家用电子设备测量的有效性/可靠性信息、完整的传播计划、初步研究的结局数据、队列保留策略的描述、治疗统计建模意图的澄清、纳入结构方程模型、增加合作研究者的努力水平、主要结局的一致性描述（儿童BMI）、样本教学材料和教学理念描述、诊所访视收入估计以及减少潜在参与者强迫入组研究的程序。

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.