Pediatric Obesity Management Intervention Trial for Hispanic Families

描述（由申请人提供）：鉴于美国西班牙裔人口的持续增长，扭转西班牙裔儿童肥胖流行病对国家未来的健康至关重要。墨西哥裔美国儿童和来自社会经济弱势家庭的儿童往往比同龄人超重和肥胖，增加了他们患肥胖相关健康并发症的风险。我们提出的随机对照试验，儿科肥胖管理试验（POM）的西班牙裔家庭，旨在改善西班牙裔儿童的身体组成，通过测试一个全面的，文化和语言相关的，以家庭为导向的干预超重和肥胖（体重指数[BMI]的第85百分位）的西班牙裔儿童6-11岁的儿科诊所在圣安东尼奥，得克萨斯州，主要是西班牙裔城市。我们的团队，由医疗保险和医疗补助服务中心（1H 0 CMS 030457）资助的试点研究期间形成，团结学术研究人员和社区合作伙伴，共同开展行为和临床干预以及与西班牙裔的外展活动。POM试验将测试为期6个月的儿童肥胖管理干预（医生咨询加电话咨询，通讯和短信）与标准护理（仅医生咨询）相比在三个结果上的疗效：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;和3）身体活动（PA）、久坐行为和含糖饮料以及水果和蔬菜的消耗的行为变化。我们将招募230名超重和肥胖儿童，每个儿童的父母或监护人，并将他们随机分配到POM干预组（n = 115名儿童/父母配对）或标准护理组（n = 115名儿童/父母配对）。从基线开始，我们将在随机化后1个月、6个月和12个月测量试验对主要结局（身体组成）和次要结局（胰岛素、葡萄糖和胆固醇水平以及几种特定健康行为变化）的影响。我们还将评估父母的策略和家庭环境的变化作为干预效果的中介的关键作用。我们假设，与标准护理的儿童相比，干预儿童将显著改善他们的身体成分，增加他们的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，这项研究将产生新的科学知识，有效的西班牙裔家庭为基础的肥胖预防方法，具有很高的潜力，在全国服务不足的地区复制。

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.