Behavioral & Pharmacologic Therapy of Adolescent Obesity

描述（由申请人提供）：肥胖是一个严重的和日益增长的健康问题，在美国的青年。例如，青少年肥胖的流行率在过去5年中从11%增加到13%，并且没有减少的迹象。这种增加伴随着2型糖尿病和其他健康并发症的急剧增加。 此次更新申请的目的是继续努力改善肥胖青少年的治疗。在过去36个月进行的一项研究中，我们发现，与单独的行为治疗相比，将减肥药物西布曲明添加到饮食和运动的综合计划中显着增加了减肥的诱导（分别为7.9公斤和3.4公斤）。本更新申请以这些调查结果为基础，解决了另外两个问题。首先，我们希望表明，在治疗的前16周内，使用1200 - 1500千卡/天的液体膳食替代品将比由具有相同卡路里目标的自选餐桌食物组成的1200 - 1500千卡/天的常规饮食引起更大的体重减轻。这一结果在几项针对成年人的研究中得到了证实，但从未在青少年中得到过验证。其次，我们希望表明，与具有相同卡路里目标的常规饮食处方相比，长期使用液体膳食替代品将显着改善17 - 52周的体重减轻的维持。液体膳食替代品将通过为参与者提供固定卡路里值的部分控制服务来促进体重减轻的诱导和维持。这种刺激缩小的方法似乎是一个很好的解毒剂超大份的高脂肪，高糖食品发现在美国今天。这项研究的参与者将是110名青少年（约66%为女性），年龄在13至17岁之间，体重指数（BMI）为30至44 kg/m2。 这项拟议中的研究是第一个随机对照试验，以检查改善肥胖青少年体重减轻的方法。我们相信，长期使用液体代餐将产生迄今为止在这一基本上被忽视的人群中获得的最佳结果。

DESCRIPTION (provided by applicant): Obesity is a serious and growing health problem in America's youth. The prevalence of adolescent obesity, for example, increased from 11% to 13% in the past 5 years and shows no signs of abating. This increase has been accompanied by a dramatic rise in type 2 diabetes and other health complications. The goal of this renewal application is to continue efforts to improve the treatment of obese adolescents. In a study conducted during the past 36 months, we found that the addition of the weight loss medication sibutramine to a comprehensive program of diet and exercise significantly increased the induction of weight loss compared with behavioral treatment alone (7.9 kg vs. 3.4 kg, respectively). This renewal application builds on these findings by addressing two additional issues. First, we wish to show that the use of a 1200-1500 kcal/day liquid-meal replacement will induce significantly greater weight losses during the first 16 weeks of treatment than will a conventional diet of 1200-1500 kcal/day comprised of self-selected table foods with the same calorie goal. This result has been obtained in several studies of adults but has never been tested in adolescents. Second, we wish to show that long-term use of a liquid meal replacement will significantly improve the maintenance of weight loss from weeks 17-52, compared with the prescription of a conventional diet with the same calorie goal. The liquid meal replacement will facilitate the induction and maintenance of weight loss by providing participants with portion-controlled servings of a fixed calorie value. This stimulus-narrowing approach would appear to be an excellent antidote to the super-sized servings of high fat, high sugar foods found in America today. Participants in this study will be 110 teens (about 66% female), who are 13 to 17 years old, and have a body mass index (BMI) of 30 to 44 kg/m 2. The proposed study is the first randomized controlled trial to examine methods of improving the maintenance of weight loss in obese teens. We believe that the long-term use of liquid meal replacement will produce the best results obtained to date in this largely neglected population.