This a proposal to participate in a program of collaborative randomized clinical trials to determine if nonpharmacologic (NPHARM) interventions can prevent increases in arterial blood pressure leading to systemic hypertension. The first phase of the program will evaluate the practicality and diastolic blood pressure effects of a number of NPHARM interventions. The second phase will use the most successful intervention from phase one to test the efficacy of a """"""""best"""""""" NPHARM intervention in reducing the incidence of new hypertension in previously normotensive individuals. Given the prevalence of hypertension in the United States, its major contribution to death and illness, the evidence for the benefits of blood pressure reduction, and the anticipated adverse consequences of widespread pharmacologic treatment of hypertension, an examination of non-drug methods for preventing high blood pressure is a high priority public health issue. After outlining phase one of the program, we document our ability to exceed the recruitment goals stated in the RFA with letters of commitment from organizations with a total population of 333,500. We also demonstrate with our Hypertension Intervention Trial results, the presence of a staff with a record of success in implementing NPHARM interventions. Within the constraints described in the RFA, a control and three intervention groups at each of ten sites with 200 participants, we propose three experiments, each with four cells. Four sites would conduct experiment one, with a control group, a maximum dietary intervention group (reduce sodium, weight, total percent fat; increase calcium, P/S ratio, potassium), a comprehensive stress management group, and a group integrating maximum diet with stress management. Three sites would execute experiment two, with a control group, a sodium restriction group, a calcium increase group, and a group combining sodium restriction and calcium increase. The final three sites would conduct experiment three, with a control group, an aerobic exercise group, a reduction in total dietary fat group, and an increase of the P/S fat ratio group. The timetable from the RFA will be followed. Recruitment will depend primarily upon direct mail solicitation, secondarily on volunteers and referrals, and to a minor degree upon community screening. We propose one screening and three baseline visits for determining eligibility and data collection, culminating in randomization.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HL037884-01
Application #
3552839
Study Section
(SRC)
Project Start
1986-09-30
Project End
1990-06-29
Budget Start
1986-09-30
Budget End
1987-06-29
Support Year
1
Fiscal Year
1986
Total Cost
Indirect Cost
Name
University of Medicine & Dentistry of NJ
Department
Type
Schools of Medicine
DUNS #
605799469
City
Newark
State
NJ
Country
United States
Zip Code
07107