TRIALS OF HYPERTENSION PREVENTION (THOP) - PHASE II

拟议的审判将分三个阶段进行。 第一阶段将是 旨在确定最佳的非药物策略， 来降低血压。 第二阶段将针对 确定最优策略能够在多大程度上 降低患有高血压的人新发高血压的发病率 正常高血压和/或临界高血压。 第三阶段将涉及结果分析。 本申请 仅用于试验的第一阶段。 十个临床 中心将招募200人，并将他们随机分配到一个 未处理的对照组，或三个独立的 降低血压的非药物治疗。 我们 建议六个单独的干预措施，三个合并的干预措施， 测试干预措施，每项干预措施都要在 三个不同的诊所，以确保结果可以 在各研究中心一致获得。 随机化受试者 将被随访36个月， 将比较不同干预组的情况， 确定阶段中使用的最佳非药物策略 二. 健康研究中心（Center for Health Research，简称CDC） 进行任何潜在的非药物干预， 并在执行大多数 候选人 我们建议联合国进行干预， 1)联合电解质干预（Na、K、Ca）; 2）联合 减肥/脂肪摄入/减少酒精/运动;以及3） 放松. 这些是最复杂和最困难的 建议的干预措施。 该公司在以下方面具有丰富的经验： 进行饮食、锻炼、体重等行为改变研究 失去，放松，也有广泛的经验， 开展高血压研究和协作临床 审判

The proposed trial will have three phases. Phase I will be directed at identifying an optimal nonpharmacological strategy for reducing blood pressure. Phase II will be aimed at determining the degree to which that optimal strategy can reduce the incidence of new hypertension among persons with high normal blood pressure and/or borderline hypertension. Phase III will involve analysis of results. This application is for Phase I of the trial only. Each of the ten clinical centers will enroll 200 persons and randomly assign them to an untreated control group, or to one of three separate nonpharmacologic treatments for reducing blood pressure. We propose that six individual interventions, and three combined interventions be tested, with each intervention being tested in three different clinics to assure that results can be consistently obtained across sites. Randomized participants will be followed for 36 months, and the blood pressure levels in the various intervention groups will be compared in order to identify the best nonpharmacologic strategy to be used in Phase II. The Center for Health Research (CHR) is prepared to conduct any of the potential nonpharmacologic interventions, and has extensive experience in conducting most of the candidates. We propose that the CHR conduct interventions in 1) combined electrolyte intervention (Na, K, Ca); 2) combined weight loss/fat intake/alcohol reduction/exercise; and 3) relaxation. These are the most complex and difficult of the proposed interventions. The CHR has considerable experience in conducting behavior change studies of diet, exercise, weight loss, and relaxation, and also has broad experience in the conduct of hypertension studies and collaborative clinical trials.