Clinic and Home Family Based Behavioral Treatment for Obese Preschoolers: LAUNCH

描述（由申请人提供）：肥胖现在影响着大约280万2至5岁的儿童，因为学龄前儿童的肥胖患病率几乎增加了两倍，从1971-1980年的5%增加到2004年的13.9%。5岁时肥胖，12岁时超重或肥胖的风险要高出47倍。事实上，在2到5年之间的任何时间肥胖，成年后超重或肥胖的风险是非肥胖学龄前儿童的四倍。学龄前儿童肥胖还会增加许多严重健康状况的风险，包括到21岁时患2型糖尿病的风险增加2.6倍。事实上，学龄前儿童的肥胖率被认为对整个生命周期造成了累积的健康风险，以至于今天出生的孩子的预期寿命将有史以来第一次比他们的父母短2到5年。在学龄前对肥胖进行早期有效治疗，有可能通过减少肥胖和改变正在形成的饮食和运动生活习惯的发展，改变肥胖和相关共病健康状况在整个生命周期中的发展轨迹。然而，关于减少学龄前儿童肥胖的干预措施的研究严重有限，而且没有一项研究针对这一年龄组的既定肥胖问题。因此，目前的研究有可能对公共卫生产生重大影响，为学龄前儿童的肥胖提供循证治疗，这一发育阶段的饮食和活动模式正在形成，可能会显著影响肥胖的轨迹，从而降低整个生命周期的人口肥胖率和相关的医疗成本。幸运的是，我们正在努力解决已经肥胖的学龄前儿童的肥胖问题。我们已经开发并进行了一项随机临床试验，旨在减少已经肥胖的学龄前儿童的肥胖。我们的项目（了解活动和了解营养促进儿童健康：LAUNCH）是针对学龄前儿童的发展阶段量身定制的，并取得了可喜的初步成果。在提议的试验中，一个三组随机平行组设计将测试LAUNCH与1)动机访谈（注意控制；MI）和2)护理标准（真正的护理标准控制；STC） 168名2至5岁符合肥胖标准的儿童（>体重指数第95百分位；BMI）。参与者将随机接受6个月的干预（LAUNCH， MI）或标准护理。主要终点将是治疗结束时BMI z评分的变化。我们还将评估治疗后6个月和12个月治疗效果的维持情况，以及被认为是体重变化机制的因素的变化（食物摄入和活动水平），致肥环境的变化（父母体重，食物摄入和活动，以及家庭食物环境的变化）和可能受到负面影响的因素（父母和孩子的饮食和喂养相互作用）。

DESCRIPTION (provided by applicant): Obesity now affects an estimated 2.8 million children between the ages of 2 and 5 years, as the prevalence of obesity among preschool school age children has almost tripled from 5 percent of the population in 1971-1980 to 13.9 percent by 2004. Being obese at age 5 confers a 47 times greater risk of being overweight or obese at age 12. In fact being obese any time between 2 and 5 year increases the risk of remaining overweight or obese as an adult by four times the risk of nonobese preschoolers. Being obese as a preschooler also increases the risk of a number of serious health conditions, including a 2.6 times greater risk of developing type 2 diabetes by age 21 years. In fact, the obesity rate among preschoolers is thought to impose such a cumulative health risk across the life span that children born today, for the first time in history, are expected to have a shorter life expectancy than their parents by to 2 to 5 years. Early effective treatments for establish obesity during the preschool years have the potential to change the trajectory of obesity and related co-morbid health condition across the life-span by reducing obesity and changing the development of lifestyle habits of diet and exercise at a time when these are being formed. Yet research on interventions to reduce obesity in preschool children is severely limited and none exist that addresses established obesity in this age group. Therefore the current study has the potential to have a significant impact on public health by providing evidence-based treatment for obesity in preschoolers, a developmental period in which eating and activity patterns are being formed, that could significantly impact the trajectory of obesity thereby decreasing the population obesity rates and associated healthcare costs at across the life span. Fortunately, we are on our way to addressing the problem of obesity reduction in already obese preschoolers. We have developed and conducted a pilot randomized clinical trial of a treatment program aimed at reducing obesity in already obese preschool children. Our program (Learning about Activity and Understanding Nutrition for Child Health: LAUNCH) is tailored to the developmental stage of preschool children and produced promising preliminary results. In the proposed trial a 3 arm, randomized, parallel group design will test LAUNCH against 1) motivational interviewing (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the criteria for obesity (>95th percentile for body mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary end-point will be change in BMI z-score at the end of treatment. We will also assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in factors thought to be mechanisms for change in weight (food intake and activity level), changes in the obesiogenic environment (parent weight, food intake and activity, and changes in the home food environment) and factors that could be negatively impacted (parent and child eating and feeding interactions).