This proposal is for Phase 1 of the proposed Trial of Hypertension Prevention, a feasibility study to determine a non-pharmacologic regimen for the prevention of sustained hypertension. A total of 200 men and women with qualifying diastolic blood pressure, 80--94 mmHG at second screening, and ages 25-49 at entry with body weight at least 10% above ideal weight, will be recruited over a nine month period. Eligible participants will be randomly assigned one of four treatment groups; 1) control, 2) weight control, 3) exercise training, or 4) weight control and exercise training. The weight control groups will have the goals of reducing caloric intake and increasing caloric expenditure in order to reduce mean body weight at least 5%. The training groups' goal will be to achieve at least a mean 10% increase in maximal exercise capacity. This Phase 1 feasibility study involves nine months of planning and nine months of recruitment with long-term follow-up of approximately 27 months allowing 3 months for final data analysis and transition to Phase 2 of the study should it be warranted. The primary objectives for this phase of the trial is to test the feasibility of providing and obtaining compliance with the nutritional/exercise interventions, and to measure the short-term effectiveness of the interventions in reducing or preventing an increase in diastolic blood pressure. Final decisions regarding the intervention modality and a common protocol with standard measurements and outcome events would await a common protocol designed by the collaborating clinics as a whole in cooperation with the coordinating center and the National Heart, Lung and Blood Institute.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL037907-06
Application #
3552885
Study Section
Special Emphasis Panel (SRC (ZZ))
Project Start
1986-09-30
Project End
1995-06-30
Budget Start
1991-07-19
Budget End
1992-06-30
Support Year
6
Fiscal Year
1991
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Type
Schools of Medicine
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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
Stevens, V J; Obarzanek, E; Cook, N R et al. (2001) Long-term weight loss and changes in blood pressure: results of the Trials of Hypertension Prevention, phase II. Ann Intern Med 134:1-11
Hunt, S C; Cook, N R; Oberman, A et al. (1998) Angiotensinogen genotype, sodium reduction, weight loss, and prevention of hypertension: trials of hypertension prevention, phase II. Hypertension 32:393-401
(1997) Effects of weight loss and sodium reduction intervention on blood pressure and hypertension incidence in overweight people with high-normal blood pressure. The Trials of Hypertension Prevention, phase II. The Trials of Hypertension Prevention Collaborativ Arch Intern Med 157:657-67
Appel, L J; Hebert, P R; Cohen, J D et al. (1995) Baseline characteristics of participants in phase II of the Trials of Hypertension Prevention (TOHP II). Trials of Hypertension Prevention (TOHP) Collaborative Research Group. Ann Epidemiol 5:149-55
Hebert, P R; Bolt, R J; Borhani, N O et al. (1995) Design of a multicenter trial to evaluate long-term life-style intervention in adults with high-normal blood pressure levels. Trials of Hypertension Prevention (phase II). Trials of Hypertension Prevention (TOHP) Collaborative Research Group. Ann Epidemiol 5:130-9

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