CLINICAL CENTER:DIET INTERVENTION IN HIGH LDL CHILDREN

本提案适用于合作试验的临床中心， 旨在评估可行性、可接受性、有效性和 旨在降低低密度的饮食干预的安全性 8岁至10岁儿童的脂蛋白（LDL）水平 低密度脂蛋白胆固醇水平升高。 健康研究中心和研究人员已经 进行了与拟议研究有关的各种研究。 其中包括几项饮食干预的合作试验， 行为矫正，以及各种治疗和 减少健康风险的示范项目。 参加波特兰中心的主要来源将是 西北地区凯撒医疗机构的成员 这 HMO注册了30万名成员，约占20%。 大都会区。 Kaiser Permanente的会员关系密切， 与大都市人口相似。 凯撒永久保险公司 有效地作为主要的征聘来源， MRFIT、BHAT和SHEP试验。 临床中心将在可行性阶段招募并 随机抽取20名自由生活、未经治疗的青春期前 8-10岁的儿童LDL胆固醇偏高。 这些儿童和 他们的家庭将被随机分配到饮食干预组， 并设常规护理对照组。 在整个试验期间，该中心将招募并随机分配80名 孩子和他们的家人研究和控制组。 研究 一组将提供一个饮食干预计划，以评估 干预的可接受性、有效性和安全性。 因为与健康有关的习惯很难改变， 因为家庭是最初学习的主要因素， 健康相关的态度和行为，干预措施是 旨在让儿童及其家庭同时参与。

This proposal is for a clinical center in collaborative trial that is designed to assess the feasibility, acceptability, efficacy, and safety of dietary intervention designed to reduce low density lipoprotein (LDL) levels in children ages eight years to ten years identified as having elevated LDL cholesterol levels. The Center for Health Research and the study investigators have conducted a variety of studies relevant to the proposed study. These include several collaborate trials of diet intervention and behavior modification, and a variety of therapeutic and demonstration projects in reducing health risk. The primary source of participants at the Portland Center will be the membership of Kaiser Permanente, Northwest Region. This HMO enrolls 300,000 members, approximately 20% of the Metropolitan Area. The Kaiser Permanente membership closely resembles the metropolitan population. Kaiser Permanente has effectively served as a primary recruitment source for the MRFIT, BHAT, and SHEP trials. The clinical center will, during the feasibility phase, recruit and randomize 20 free-living, previously untreated prepubescent children ages 8-10 with high LDL cholesterol. These children and their families will be randomized into a dietary intervention group and a usual care control group. During the full trial the center will recruit and randomize 80 children and their families to study and control groups. The study group will be offered a diet intervention program, to assess the acceptability, efficacy, and safety of the intervention. Because health-related habits are so resistant to change and because the family is a primary factor in the initial learning of health-related attitudes and behaviors, the intervention is designed to involve children and their families simultaneously.