TRIALS OF HYPERTENSION PREVENTION (TOHP) PHASE II

这项试验的主要目的是比较不同的 非药理学措施降低或 防止舒张压（DBP）升高。 作为一个拟议的临床中心，为国家试验 高血压预防（TOHP），我们建议招募225名 第一阶段有450人参加，第二阶段有450人参加。 招聘将基于两个战略。 参与者 将为基线DBP 80-94的25-49岁男性和女性 毫米汞柱。 主要的策略将包括大量邮寄 向75，000至100，000名符合资格的老年人发送信件和小册子。 第二项战略将包括社区筛查 10，000名符合资格的老年人在购物等社区场所 商场、药店和教堂。 为了获得一个风险增加的研究队列， 舒张期高血压的后续发展，我们建议 所有参与者都有一个或多个潜在风险， 中所述的高血压发生的因素 提议 提案中还列出了排除标准。 受试者将被随机分配至三个治疗组之一 或对照组。 详细的知情同意书将 必需的. 我们对最终选择的干预措施持灵活态度 并讨论各种非药物干预。 两 小组和个性化的干预措施将在一个 努力改变行为。 小组干预将是 接下来的三波密集的每周会议 通过每月一次的会议 干预措施将涉及 教育目标设定，示范，持续遵守 监控反馈和奖励 一种“分级护理”方法， 将根据对遵守情况的监测采取干预措施。 干预会议将与数据收集分开 会议将由不同的人员进行。 数据 所有组的数据都包括血压 （Hawksley随机零），体重，身高，皮褶厚度， 其他物理措施、行为措施和具体措施 “客观”的合规监测。 客观合规监测员 用于数据目的将不同于遵守 干预措施中使用的监视器。 将为时间安排和后续行动制定广泛的计划 （包括访视时间窗）、干预和门诊流程、数据 收集和录入以及质量控制。 项目 研究人员将积极参与指定的 国家研究会议。

The primary purpose of this trial is to compare different non-pharmacologic measures in their ability to reduce or prevent an increase in diastolic pressure (DBP). As a proposed clinic center for the national Trial of Hypertension Prevention (TOHP), we propose to recruit 225 participants for Phase I and 450 participants for Phase II. Recruitment will be based on two strategies. Participants would be males and females aged 25-49 with baseline DBP 80-94 mmHg. The primary strategy will consist of a mass mailing of letters and brochures to 75,000-100,000 age eligible persons. The secondary strategy will consist of community screening of 10,000 age eligible persons at community sites such as shopping malls, drugstores, and churches. In order to obtain a study cohort at increased risk for the subsequent development of diastolic hypertension we propose that all participants have one or more of the potential risk factors for the development of hypertension described in the proposal. Exclusion criteria are also listed in the proposal. Participants will be randomized to one of three treatment arms or to the control group. Detailed informed consent will be required. We are flexible on the ultimate interventions chosen and discuss a variety of non-pharmacologic interventions. Both group and individualized interventions would be provided in an effort to modify behavior. Group interventions would be structured in three waves of intensive weekly sessions followed by monthly maintainance sessions. Interventions will involve education goal setting, demonstration, continued compliance monitoring, feedback, and reward. A "stepped care" approach to intervention would be used based on compliance monitoring. Intervention sessions would be separate from data collection sessions and would be conducted by different personnel. Data to be collected for all groups would include blood pressure (Hawksley random zero), weight, height, skinfold thickness, other physical measures, behavioral measures and specific "objective" compliance monitor. Objective compliance monitors for data purposes would be different from the compliance monitors used in the interventions. Extensive plans would be developed for scheduling and follow-up (including visit windows), intervention and clinic flow, data collection and entry, and quality control. The project investigators would actively participate in the specified national study meetings.