Pediatric Obesity Management Intervention Trial for Hispanic Families

摘要 鉴于美国拉美裔人口的持续增长，扭转拉美裔儿童肥胖症 流行病对这个国家未来的健康至关重要。墨西哥裔美国儿童和来自 社会经济上处于不利地位的家庭往往比他们的家庭超重和肥胖得多 同龄人，增加了他们患肥胖相关健康并发症的风险。我们建议的随机化 对照试验， 针对西班牙裔家庭的儿科肥胖管理试验(POM)旨在 通过测试全面的、文化的和 在语言上具有相关性，以家庭为导向的超重和肥胖干预(例如 第85个百分位数 体重指数[BMI]) 西班牙裔儿童年龄在6-11岁之间 德克萨斯州圣安东尼奥的儿科诊所 以西班牙裔为主的城市。我们的团队是在我们的试点研究期间组成的，该研究由 Medicare and Medicaid Services(1H0CMS030457)，将学术研究人员和 具有共同开展行为和临床工作经验的社区合作伙伴 对拉美裔美国人的干预和宣传。POM试验将测试为期6个月的 儿童肥胖管理干预(医生咨询+电话咨询， 时事通讯和短信)与标准护理(仅限医生咨询)相比， 结果：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 摄入含糖饮料、水果和蔬菜。我们将招募230名超重和 肥胖儿童--以及每个儿童的父母或监护人--并随机对他们进行POM干预 (n=115名儿童/父母双亲)或标准照料(n=115名儿童/父母双亲)。从基线来看，我们 将衡量试验对主要结果(身体成分)和次要结果的影响 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) 随机化后1个月、6个月和12个月。我们还将评估养育子女的关键作用 家庭环境的策略和变化作为干预效果的中介。我们 假设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(多吃水果和蔬菜，少喝含糖饮料) 与接受标准护理的儿童相比，减少他们的久坐活动。如果成功，这项研究 将产生关于有效的拉美裔家庭方法的新的科学知识 肥胖预防具有在全国服务不足地区复制的高潜力。

ABSTRACT 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.