TRIALS OF HYPERTENSION PREVENTION (TOHP) - PHASE II

本提案适用于拟议试验的第1阶段， 高血压的预防，可行性研究，以确定一个 非药物治疗预防持续性 高血压 总共有200名男女选手 第二次筛选时舒张压为80- 94 mmHG，以及 入组时年龄为25-49岁，体重至少比理想体重高出10% 体重，将在9个月内招募。 资格 参与者将被随机分配四种治疗之一， 组; 1）对照组，2）体重控制组，3）运动训练组，或 4)体重控制和运动训练。 该权重控制 小组的目标是减少热量摄入， 增加热量消耗以减少平均体重 重量至少5%。 培训小组的目标是 最大运动量平均增加至少10% 容量 第一阶段可行性研究为期九个月 规划和9个月的征聘， 随访约27个月，其中3个月用于 最终数据分析并过渡到研究的II期 如果有必要的话 本阶段的主要目标 试验的目的是测试提供和 获得对营养/锻炼的依从性 干预措施，并衡量短期有效性 为减少或防止儿童死亡率上升而采取的干预措施 舒张压 最后决定 干预模式和具有标准共同协议 测量和结果事件将等待共同的协议 由合作诊所共同设计， 与协调中心和国家心脏，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.