Pediatric Obesity Management Intervention Trial for Hispanic Families

描述(申请人提供)：鉴于美国拉美裔人口的持续增长，扭转拉美裔儿童肥胖症的流行对美国未来的健康至关重要。墨西哥裔美国儿童和那些来自社会经济困难家庭的儿童往往比他们的同龄人超重和肥胖得多，增加了他们患肥胖症相关健康并发症的风险。我们建议的随机对照试验，即针对拉美裔家庭的儿科肥胖管理试验(POM)，旨在通过在德克萨斯州圣安东尼奥的儿科诊所测试针对超重和肥胖(身体质量指数[BMI]的第85个百分位数)的拉美裔儿童的全面、文化和语言相关的、以家庭为导向的干预措施，以改善拉美裔儿童的身体组成。我们的团队是在我们由医疗保险和医疗补助服务中心(1H0CMS030457)资助的试点研究期间组成的，将学术研究人员和具有合作经验的社区合作伙伴团结在一起，进行行为和临床干预以及与拉美裔美国人的接触。POM试验将测试为期6个月的儿科肥胖管理干预(医生咨询加上电话咨询、时事通讯和短信)与标准护理(仅限医生咨询)在三个方面的效果：1)身体成分(即腰围、体重和z-BMI)；2)胰岛素、葡萄糖和胆固醇水平；以及3)体力活动(PA)、久坐行为和含糖饮料和水果蔬菜消费的行为变化。我们将招募230名超重和肥胖儿童--每个儿童都有一名父母或监护人--并将他们随机分配到POM干预组(n=115名儿童/父母对偶)或标准护理(n=115名儿童/父母对偶)。在基线的基础上，我们将在随机化后1个月、6个月和12个月衡量试验对主要结果(身体成分)和次要结果(胰岛素、血糖和胆固醇水平以及几种特定的健康行为变化)的影响。我们还将评估育儿策略和家庭环境变化作为干预效果中介的关键作用。我们假设，与标准护理中的儿童相比，干预后的儿童将显著改善他们的身体成分，提高他们的PA水平和饮食质量(更多的水果和蔬菜，更少的含糖饮料)，并减少他们的久坐活动。如果成功，这项研究将产生关于有效的基于西班牙裔家庭的肥胖预防方法的新的科学知识，在全国服务不足的地区具有很高的复制潜力。

DESCRIPTION (provided by applicant): Given the continuing rise of the U.S. Hispanic population, reversing the Hispanic childhood obesity epidemic is critical to the nation's future health. Mexican American children and those from socioeconomically disadvantaged families often are far more overweight and obese than their peers, heightening their risk for obesity-related health complications. Our proposed randomized controlled trial, the Pediatric Obesity Management Trial (POM) for Hispanic Families, aims to improve Hispanic children's body composition by testing a comprehensive, culturally and linguistically relevant, family-oriented intervention for overweight and obese (e 85th percentile of body mass index [BMI]) Hispanic children ages 6-11 in pediatric clinics in San Antonio, Texas, a largely Hispanic city. Our team, formed during our pilot research funded by the Centers for Medicare and Medicaid Services (1H0CMS030457), unites academic investigators and community partners with experience working together to conduct behavioral and clinical interventions and outreach with Hispanics. The POM trial will test the efficacy of a 6-month pediatric obesity management intervention (physician counseling plus telephone counseling, newsletters and text messages) compared to standard care (physician counseling only) on three outcomes: 1) body composition (i.e., waist circumference, weight and z-BMI); 2) insulin, glucose and cholesterol levels; and 3) behavior change in physical activity (PA), sedentary behavior and consumption of sugary beverages and fruits and vegetables. We will recruit 230 overweight and obese children-and a parent or guardian for each-and randomize them to the POM intervention (n = 115 child/parent dyads) or standard care (n = 115 child/parent dyads). From a baseline, we will measure the impact of the trial on the primary outcome (body composition) and secondary outcomes (insulin, glucose and cholesterol levels and several specific health behavior changes) at 1 month, 6 and 12 months post-randomization. We also will evaluate the critical role of parenting strategies and changes in the home environment as mediators of intervention effects. We hypothesize that intervention children will significantly improve their body composition, increased their PA levels and diet quality (more fruits and vegetables and less sugary beverages), and decrease their sedentary activity, compared to children in standard care. If successful, this study will generate new scientific knowledge about effective Hispanic family-based approaches for obesity prevention with high potential for replication in underserved areas across the nation.