TRIALS OF HYPERTENSION PREVENTION (TOHP) PHASE II

这项试验的主要目的是比较不同的 非药物措施的能力，减少或 防止舒张压(DBP)升高。 作为全国试验的拟议临床中心 高血压预防(TOHP)，我们建议招募225人 第一阶段的参与者和第二阶段的450人。 招聘将基于两个战略。参与者 男性和女性年龄25-49岁，基线舒张压80-94 毫米汞柱。主要战略将包括大量邮寄 向75,000-100,000名符合资格的人发出信件和小册子。 次要战略将包括以下社区筛选 10,000名符合年龄标准的人在购物等社区网站 商场、药店和教堂。 为了获得风险更高的研究队列 我们建议舒张期高血压的后续发展 所有参与者都有一个或多个潜在风险 高血压发展的因素描述在 求婚。提案中还列出了排除标准。 参与者将被随机分配到三个治疗组中的一个 或给对照组注射。详细的知情同意将是 必填项。我们对最终选择的干预措施是灵活的 并讨论各种非药物干预措施。两者都有 小组和个别化干预将在 努力改变行为。小组干预将是 紧随其后的是每周三波密集的会议 通过每月的维护会议。干预措施将涉及 教育目标设定、示范、持续合规 监控、反馈和奖励。“分步护理”的方法 将在合规监测的基础上进行干预。 干预会议将与数据收集分开 会议将由不同的人员主持。数据 为所有人群收集的数据将包括血压 (霍克斯利随机零)，体重，身高，皮褶厚度， 其他身体测量、行为测量和特定的 “客观的”遵从性监测。目标遵从性监测员 用于数据目的将不同于合规性 干预中使用的监视器。 将为日程安排和后续行动制定广泛的计划 (包括访问窗口)、干预和临床流程、数据 收集和录入，以及质量控制。该项目 调查人员将积极参与指定的 全国学习会议。

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.