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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL037849-07
Application #
3552801
Study Section
Special Emphasis Panel (SRC (ZZ))
Project Start
1986-09-30
Project End
1995-06-30
Budget Start
1992-07-01
Budget End
1993-06-30
Support Year
7
Fiscal Year
1992
Total Cost
Indirect Cost
Name
University of Tennessee Health Science Center
Department
Type
Schools of Medicine
DUNS #
941884009
City
Memphis
State
TN
Country
United States
Zip Code
38163
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
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
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 (1998) Effect of change in sodium excretion on change in blood pressure corrected for measurement error. The Trials of Hypertension Prevention, Phase I. Am J Epidemiol 148:431-44
Hollis, J F; Satterfield, S; Smith, F et al. (1995) Recruitment for phase II of the Trials of Hypertension Prevention. Effective strategies and predictors of randomization. Trials of Hypertension Prevention (TOHP) Collaborative Research Group. Ann Epidemiol 5:140-8
Lasser, V I; Raczynski, J M; Stevens, V J et al. (1995) Trials of Hypertension Prevention, phase II. Structure and content of the weight loss and dietary sodium reduction interventions. Trials of Hypertension Prevention (TOHP) Collaborative Research Group. Ann Epidemiol 5:156-64
Kumanyika, S K; Hebert, P R; Cutler, J A et al. (1993) Feasibility and efficacy of sodium reduction in the Trials of Hypertension Prevention, phase I. Trials of Hypertension Prevention Collaborative Research Group. Hypertension 22:502-12
Satterfield, S; Borhani, N O; Whelton, P et al. (1993) Recruitment for phase I of the trials of hypertension prevention. Am J Prev Med 9:237-43

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