Behavioral & Pharmacologic Therapy of Adolescent Obesity

描述(申请人提供)：肥胖是美国年轻人中一个严重且日益严重的健康问题。例如，青少年肥胖症的患病率在过去5年里从11%上升到13%，而且没有任何减少的迹象。伴随着这一增长的是2型糖尿病和其他健康并发症的急剧增加。 这项续签申请的目标是继续努力改善肥胖青少年的治疗。在过去36个月中进行的一项研究中，我们发现，与单纯的行为治疗相比，在全面的饮食和锻炼计划中加入减肥药西布曲明显著增加了体重减轻的诱导(分别为7.9公斤和3.4公斤)。此续订申请是在这些调查结果的基础上提出的，解决了另外两个问题。首先，我们希望证明，在治疗的前16周内，使用1200-1500卡路里/天的液体餐替代品将比使用1200-1500卡路里/天的传统饮食(包括具有相同卡路里目标的自选餐桌食物)的体重减轻幅度要大得多。这一结果已经在几项成人研究中获得，但从未在青少年身上进行过测试。其次，我们希望证明长期使用流质膳食替代品将显著改善从第17-52周开始的减肥效果，而不是使用相同卡路里目标的传统饮食处方。通过为参与者提供固定卡路里值的部分控制服务，液体餐替代将有助于诱导和保持体重减轻。这种缩小刺激范围的方法似乎是应对当今美国出现的超大份量的高脂肪、高糖食物的绝佳解药。这项研究的参与者将是110名青少年(约66%女性)，他们的年龄在13岁到17岁之间，体重指数(BMI)在30到44公斤/平方米之间。 这项拟议的研究是第一个检验改善肥胖青少年减肥效果的方法的随机对照试验。我们认为，长期使用流质膳食替代品将在这一基本上被忽视的人群中产生迄今所取得的最好结果。

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.