TRIALS OF HYPERTENSION PREVENTION (TOHP) - PHASE II

这项建议是为拟议的试验的第一阶段 高血压预防，一项可行性研究，以确定 预防慢性阻塞性肺疾病的非药物疗法 高血压。共有200名男女选手参加了排位赛 第二次筛查时舒张压为80-94毫米汞柱，以及 入职年龄25-49岁，体重至少比理想体重高10% 体重，将在九个月内招募。合资格 参与者将被随机分配到四种治疗中的一种 分组；1)对照组，2)体重控制，3)运动训练，或 4)控制体重和运动训练。体重控制 团体的目标是减少卡路里摄入量和 增加热量消耗，以减少平均身体 权重至少为5%。培训小组的目标将是 最大运动量平均至少增加10% 容量。本阶段可行性研究为期9个月。 计划和9个月的长期招聘 约27个月的随访，允许3个月的 最终数据分析和过渡到研究的第二阶段 如果有必要的话。这一阶段的主要目标 试验的目的是测试提供和提供 获得营养/锻炼的依从性 干预措施，并衡量其短期效果。 减少或防止增加的干预措施 舒张压。有关的最终决定 干预方式和具有标准的通用方案 测量和结果事件将等待一个共同的协议 由合作诊所整体合作设计 与协调中心和国家心肺和 血液研究所。

This proposal is for Phase 1 of the proposed Trial of Hypertension Prevention, a feasibility study to determine a non-pharmacologic regimen for the prevention of sustained hypertension. A total of 200 men and women with qualifying diastolic blood pressure, 80--94 mmHG at second screening, and ages 25-49 at entry with body weight at least 10% above ideal weight, will be recruited over a nine month period. Eligible participants will be randomly assigned one of four treatment groups; 1) control, 2) weight control, 3) exercise training, or 4) weight control and exercise training. The weight control groups will have the goals of reducing caloric intake and increasing caloric expenditure in order to reduce mean body weight at least 5%. The training groups' goal will be to achieve at least a mean 10% increase in maximal exercise capacity. This Phase 1 feasibility study involves nine months of planning and nine months of recruitment with long-term follow-up of approximately 27 months allowing 3 months for final data analysis and transition to Phase 2 of the study should it be warranted. The primary objectives for this phase of the trial is to test the feasibility of providing and obtaining compliance with the nutritional/exercise interventions, and to measure the short-term effectiveness of the interventions in reducing or preventing an increase in diastolic blood pressure. Final decisions regarding the intervention modality and a common protocol with standard measurements and outcome events would await a common protocol designed by the collaborating clinics as a whole in cooperation with the coordinating center and the National Heart, Lung and Blood Institute.