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

描述（由申请人提供）：肥胖现在影响着估计280万2至5岁的儿童，学龄前儿童肥胖的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岁时肥胖的人在12岁时超重或肥胖的风险要高出47倍。事实上，在2到5岁之间的任何时候肥胖都会增加成年后超重或肥胖的风险，其风险是非肥胖学龄前儿童的四倍。肥胖作为一种学龄前疾病也会增加一些严重健康状况的风险，包括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在整个生命周期中造成了累积的健康风险，以至于今天出生的孩子，历史上第一次，预期寿命比他们的父母短2到5年。对学龄前肥胖的早期有效治疗有可能通过减少肥胖和改变饮食和锻炼的生活方式习惯的形成来改变整个生命周期中肥胖和相关共病健康状况的轨迹。然而，关于减少学龄前儿童肥胖的干预措施的研究非常有限，并且没有解决这个年龄组的既定肥胖问题。因此，目前的研究有可能通过为学龄前儿童的肥胖提供循证治疗对公共卫生产生重大影响，学龄前儿童是一个饮食和活动模式正在形成的发育期，这可能会显着影响肥胖的轨迹，从而降低人口肥胖率和整个生命周期的相关医疗费用。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减少问题。我们已经开发并进行了一项旨在减少已经肥胖的学龄前儿童肥胖的治疗计划的试点随机临床试验。我们的计划（了解活动和了解儿童健康营养：启动）是针对学龄前儿童的发育阶段，并产生了可喜的初步成果。在拟议的试验中，3组、随机、平行组设计将测试LAUNCH与1）动机访谈（注意力控制; MI）和2）护理标准（真正的护理标准控制; STC）的对比，其中168名2至5岁的儿童符合肥胖标准（体重指数> 95百分位数; BMI）。受试者将随机接受6个月的干预（LAUNCH，MI）或标准治疗。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个月时治疗增益的维持，以及被认为是体重变化机制的因素（食物摄入量和活动水平）的变化，致肥胖环境的变化（父母体重，食物摄入量和活动，以及家庭食物环境的变化）和可能产生负面影响的因素（父母和孩子的饮食和喂养相互作用）。 公共卫生相关性：学龄前儿童的肥胖症是一个严重的健康问题，影响到大约280万2至5岁的儿童。没有治疗研究来减少这个年龄组的肥胖症。由于学龄前儿童的肥胖会影响到儿童和成年，并增加1型糖尿病等疾病的可能性，因此对学龄前儿童进行有效的治疗至关重要，以便在整个生命过程中改变肥胖和合并症的轨迹。如果不进行干预，据推测，肥胖趋势将继续发生在更年轻的年龄，儿童将在其生命的更大部分时间内承担与肥胖相关的健康风险，并且，历史上第一次，今天出生的儿童的预期寿命将比他们的父母短。

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). PUBLIC HEALTH RELEVANCE: Obesity among preschool children is a significant health problem affecting approximately 2.8 million children ages 2 to 5 years. There are no treatment studies to reduce established obesity in this age group. Because obesity during the preschool years tracks into childhood and adulthood and increases the likelihood of disorders such as type 1 diabetes, effective treatments for preschoolers are critical in order to change the trajectory of obesity and co-morbidities throughout the life course. Without intervention it is speculated that obesity trends will continue to occur at younger ages, children will carry obesity related health risks for a greater portion of their lives, and, for the first time in history, children born today will have a shorter life expectancy than their parents.