Pediatric Obesity Management Intervention Trial for Hispanic Families

摘要 鉴于美国西班牙裔人口的持续上升，扭转西班牙裔儿童肥胖 疫情对国家未来的健康至关重要。墨西哥裔美国儿童和来自 社会经济上处于不利地位的家庭往往比他们的家庭更超重和肥胖。 同龄人，增加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， 西班牙裔家庭儿童肥胖管理试验（POM）旨在 通过测试一个全面的，文化上的， 语言相关的，面向家庭的超重和肥胖干预（e 第85百分位数 体重指数） 6-11岁的西班牙裔儿童 德克萨斯州圣安东尼奥的儿科诊所， 大部分是西班牙裔城市。我们的团队，在我们的试点研究期间成立，由中心资助， 医疗保险和医疗补助服务（1H 0 CMS 030457），联合学术研究人员和 具有经验的社区合作伙伴共同开展行为和临床研究， 与拉美裔的干预和外联。POM试验将测试为期6个月的 小儿肥胖管理干预（医生咨询加电话咨询， 通讯和短信）相比，标准护理（仅医生咨询） 结果：1）身体组成（即，腰围、体重和z-BMI）; 2）胰岛素、葡萄糖 和胆固醇水平;以及3）身体活动（PA）、久坐行为和 食用含糖饮料和水果蔬菜。我们将招募230名超重和 肥胖儿童-和父母或监护人为每个-并随机分配他们到POM干预 （n = 115个儿童/父母二人组）或标准治疗（n = 115个儿童/父母二人组）。从基线来看，我们 将测量试验对主要结局（身体组成）和次要结局的影响 结果（胰岛素、葡萄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 策略和家庭环境的变化作为干预效果的中介。我们 假设干预儿童将显着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）， 与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 将产生关于有效的西班牙裔家庭为基础的方法， 肥胖预防在全国服务不足的地区具有很高的复制潜力。

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.