DIETARY INTERVENTION STUDY IN CHILDREN (DISC II)

儿童饮食干预研究(DISC)是一个多中心的研究， 饮食干预降血压的随机对照临床试验 663名8~10岁儿童低密度脂蛋白-胆固醇水平 Tanner I阶段为基线。这项建议旨在延长研究时间。 再花七年时间调查长期安全性， 修改总脂肪饮食的有效性、可行性和可接受性， 饱和脂肪和膳食胆固醇在青春期前和 一直持续到青春期。在DISC I期间，芝加哥DISC中心 成功招募并随机选择了116名符合条件的儿童，比 六个中心每个中心100名儿童的目标。光盘I是 完成其资助的七年中的第六年，最初包括 随后进行了七个月的规划和礼仪制定(第一阶段) 经过17个月的可行性测试(第二阶段)，然后全面 规模饮食干预试验，随访范围在36-60 3个月，视随机时间而定(第三阶段)。第四阶段 最初计划用于数据分析和报告。这项建议 包括继续研究，直到孩子们年满18岁， 通过完成青春期和达到或接近成年身材 所以脂肪所产生的最终生长、身材和成熟 可以评估修改后的饮食。 详细说明设计、数据收集、当前 整个研究的进展和初步结果已提交给 光盘协调中心。这项建议是专门针对芝加哥的 DISC中心及其作为临床中心在DISII中的作用。

The Dietary Intervention Study in Children (DISC) is a multi-center, randomized controlled clinical trial of dietary intervention to lower LDL-cholesterol level (LDL-C) in 663 children who were 8-10 years of age and Tanner Stage I at baseline. This proposal seeks to extend the study for an additional seven years to investigate the long-term safety, efficacy, feasibility and acceptability of a diet modified in total fat, saturated fat and dietary cholesterol initiated in pre-pubescence and continued throughout adolescence. During DISC I, the Chicago DISC Center successfully recruited and randomized 116 eligible children, 16 more than the goal of 100 children per each of the six centers. DISC I is completing the sixth of its funded seven years, consisting initially of seven months of planning and protocol development, (Phase I), followed by seventeen months of feasibility testing (Phase II), and then the full scale dietary intervention trial with follow-up ranging between 36-60 months depending upon the time of randomization (Phase III). Phase IV was originally planned for data analyses and reporting. This proposal involves continuation of the study until children reach 18 years of age, through completion of puberty and achievement of at or near adult stature so that final growth, stature and maturation resulting from the fat modified diet can be assessed. A central proposal detailing the design, data collection, current progress and preliminary results for entire study has been submitted by the DISC Coordinating Center. This proposal is specific to the Chicago DISC Center and its role in DISC II as a clinical center.