TRIALS OF HYPERTENSION PREVENTION (TOHP) PHASE II

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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.