The proposed trial will have three phases. Phase I will be directed at identifying an optimal nonpharmacological strategy for reducing blood pressure. Phase II will be aimed at determining the degree to which that optimal strategy can reduce the incidence of new hypertension among persons with high normal blood pressure and/or borderline hypertension. Phase III will involve analysis of results. This application is for Phase I of the trial only. Each of the ten clinical centers will enroll 200 persons and randomly assign them to an untreated control group, or to one of three separate nonpharmacologic treatments for reducing blood pressure. We propose that six individual interventions, and three combined interventions be tested, with each intervention being tested in three different clinics to assure that results can be consistently obtained across sites. Randomized participants will be followed for 36 months, and the blood pressure levels in the various intervention groups will be compared in order to identify the best nonpharmacologic strategy to be used in Phase II. The Center for Health Research (CHR) is prepared to conduct any of the potential nonpharmacologic interventions, and has extensive experience in conducting most of the candidates. We propose that the CHR conduct interventions in 1) combined electrolyte intervention (Na, K, Ca); 2) combined weight loss/fat intake/alcohol reduction/exercise; and 3) relaxation. These are the most complex and difficult of the proposed interventions. The CHR has considerable experience in conducting behavior change studies of diet, exercise, weight loss, and relaxation, and also has broad experience in the conduct of hypertension studies and collaborative clinical trials.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL037899-08
Application #
3552858
Study Section
Special Emphasis Panel (SRC (ZZ))
Project Start
1986-09-30
Project End
1995-06-30
Budget Start
1993-07-01
Budget End
1994-06-30
Support Year
8
Fiscal Year
1993
Total Cost
Indirect Cost
Name
Kaiser Foundation Research Institute
Department
Type
DUNS #
City
Oakland
State
CA
Country
United States
Zip Code
94612
Cook, Nancy R; Appel, Lawrence J; Whelton, Paul K (2014) Lower levels of sodium intake and reduced cardiovascular risk. Circulation 129:981-9
Cook, Nancy R; Obarzanek, Eva; Cutler, Jeffrey A et al. (2009) Joint effects of sodium and potassium intake on subsequent cardiovascular disease: the Trials of Hypertension Prevention follow-up study. Arch Intern Med 169:32-40
Cook, Nancy R; Cutler, Jeffrey A; Obarzanek, Eva et al. (2007) Long term effects of dietary sodium reduction on cardiovascular disease outcomes: observational follow-up of the trials of hypertension prevention (TOHP). BMJ 334:885-8
Kumanyika, S K; Cook, N R; Cutler, J A et al. (2005) Sodium reduction for hypertension prevention in overweight adults: further results from the Trials of Hypertension Prevention Phase II. J Hum Hypertens 19:33-45
Cook, N R; Kumanyika, S K; Cutler, J A et al. (2005) Dose-response of sodium excretion and blood pressure change among overweight, nonhypertensive adults in a 3-year dietary intervention study. J Hum Hypertens 19:47-54
Karanja, Njeri; Stevens, Victor J; Hollis, Jack F et al. (2002) Steps to soulful living (steps): a weight loss program for African-American women. Ethn Dis 12:363-71