Trials of Hypertension Prevention (TOHP)

This study has been completed.

First Received: October 27, 1999 Last Updated: January 3, 2006 History of Changes

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000528

Purpose

To determine if nonpharmacological interventions, including diet and lifestyle change, could prevent increases in arterial blood pressure leading to systemic hypertension.

Condition	Intervention	Phase
Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases	Behavioral: diet, sodium-restricted (Phase III) diet, sodium-restricted Behavioral: diet, reducing (Phase III)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Factorial Assignment

Resource links provided by NLM:

MedlinePlus related topics: Diets Heart Diseases High Blood Pressure Vascular Diseases

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:	September 1986
Estimated Study Completion Date:	June 1998

Show Detailed Description

Eligibility

Ages Eligible for Study:	30 Years to 54 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Men and women, ages 30 to 54, with high normal diastolic blood pressure between 83 and 89 mm Hg.

Subjects were mildly obese.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000528

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:

Charles Hennekens

Brigham and Women's Hospital

More Information

Publications:

Kumanyaka SK, Obarzanek E, Stevens VJ, Hebert PR, Whelton PK. Weight-loss experience of black and white participants in NHLBI-sponsored clinical trials. Am J Clin Nutr. 1991 Jun;53(6 Suppl):1631S-1638S.

Rosner B, Langford HG. Judging the effectiveness of antihypertensive therapy in an individual patient. J Clin Epidemiol. 1991;44(8):831-8.

Satterfield S, Cutler JA, Langford HG, Applegate WB, Borhani NO, Brittain E, Cohen JD, Kuller LH, Lasser NL, Oberman A, et al. Trials of hypertension prevention. Phase I design. Ann Epidemiol. 1991 Aug;1(5):455-71.

Whelton PK, Hebert PR, Cutler J, Applegate WB, Eberlein KA, Klag MJ, Keough ME, Hamill S, Borhani NO, Hollis J, et al. Baseline characteristics of participants in phase I of the Trials of Hypertension Prevention. Ann Epidemiol. 1992 May;2(3):295-310.

[No authors listed] The effects of nonpharmacologic interventions on blood pressure of persons with high normal levels. Results of the Trials of Hypertension Prevention, Phase I. JAMA. 1992 Mar 4;267(9):1213-20.

Kumanyika SK, Hebert PR, Cutler JA, Lasser VI, Sugars CP, Steffen-Batey L, Brewer AA, Cameron M, Shepek LD, Cook NR, et al. Feasibility and efficacy of sodium reduction in the Trials of Hypertension Prevention, phase I. Trials of Hypertension Prevention Collaborative Research Group. Hypertension. 1993 Oct;22(4):502-12.

Satterfield S, Borhani NO, Whelton P, Goodwin L, Brinkmann C, Charleston J, Corkery BW, Dolan L, Hataway H, Hertert S, et al. Recruitment for phase I of the trials of hypertension prevention. Am J Prev Med. 1993 Jul-Aug;9(4):237-43.

Cook NR, Rosner BA. Screening rules for determining blood pressure status in clinical trials. Application to the trials of hypertension prevention. Am J Epidemiol. 1993 Jun 15;137(12):1341-52.

Stevens VJ, Corrigan SA, Obarzanek E, Bernauer E, Cook NR, Hebert P, Mattfeldt-Beman M, Oberman A, Sugars C, Dalcin AT, et al. Weight loss intervention in phase 1 of the Trials of Hypertension Prevention. The TOHP Collaborative Research Group. Arch Intern Med. 1993 Apr 12;153(7):849-58.

Sacks FM, Hebert P, Appel LJ, Borhani NO, Applegate WB, Cohen JD, Cutler JA, Kirchner KA, Kuller LH, Roth KJ, et al. Short report: the effect of fish oil on blood pressure and high-density lipoprotein-cholesterol levels in phase I of the Trials of Hypertension Prevention. J Hypertens. 1994 Feb;12(2):209-13.

Kahn HA, Whelton PK, Appel LJ, Kumanyika SK, Meneses JL, Hebert PR, Woods M. Validity of 24-hour dietary recall interviews conducted among volunteers in an adult working community. Ann Epidemiol. 1995 Nov;5(6):484-9.

Appel LJ, Hebert PR, Cohen JD, Obarzanek E, Yamamoto M, Buring J, Stevens V, Kirchner K, Borhani NO. 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. 1995 Mar;5(2):149-55.

Whelton PK, Buring J, Borhani NO, Cohen JD, Cook N, Cutler JA, Kiley JE, Kuller LH, Satterfield S, Sacks FM, et al. The effect of potassium supplementation in persons with a high-normal blood pressure. Results from phase I of the Trials of Hypertension Prevention (TOHP). Trials of Hypertension Prevention (TOHP) Collaborative Research Group. Ann Epidemiol. 1995 Mar;5(2):85-95.

Yamamoto ME, Applegate WB, Klag MJ, Borhani NO, Cohen JD, Kirchner KA, Lakatos E, Sacks FM, Taylor JO, Hennekens CH. Lack of blood pressure effect with calcium and magnesium supplementation in adults with high-normal blood pressure. Results from Phase I of the Trials of Hypertension Prevention (TOHP). Trials of Hypertension Prevention (TOHP) Collaborative Research Group. Ann Epidemiol. 1995 Mar;5(2):96-107.

Hebert PR, Bolt RJ, Borhani NO, Cook NR, Cohen JD, Cutler JA, Hollis JF, Kuller LH, Lasser NL, Oberman A, et al. 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. 1995 Mar;5(2):130-9.

Lasser VI, Raczynski JM, Stevens VJ, Mattfeldt-Beman MK, Kumanyika S, Evans M, Danielson E, Dalcin A, Batey DM, Belden LK, et al. 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. 1995 Mar;5(2):156-64.

Cook NR, Cohen J, Hebert PR, Taylor JO, Hennekens CH. Implications of small reductions in diastolic blood pressure for primary prevention. Arch Intern Med. 1995 Apr 10;155(7):701-9.

Whelton PK, Kumanyika SK, Cook NR, Cutler JA, Borhani NO, Hennekens CH, Kuller LH, Langford H, Jones DW, Satterfield S, Lasser NL, Cohen JD. Efficacy of nonpharmacologic interventions in adults with high-normal blood pressure: results from phase 1 of the Trials of Hypertension Prevention. Trials of Hypertension Prevention Collaborative Research Group. Am J Clin Nutr. 1997 Feb;65(2 Suppl):652S-660S.

[No authors listed] 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 Collaborative Research Group. Arch Intern Med. 1997 Mar 24;157(6):657-67.

Pickering TG. Lessons from the Trials of Hypertension Prevention, phase II. Energy intake is more important than dietary sodium in the prevention of hypertension. Arch Intern Med. 1997 Mar 24;157(6):596-7. No abstract available.

Hunt SC, Cook NR, Oberman A, Cutler JA, Hennekens CH, Allender PS, Walker WG, Whelton PK, Williams RR. Angiotensinogen genotype, sodium reduction, weight loss, and prevention of hypertension: trials of hypertension prevention, phase II. Hypertension. 1998 Sep;32(3):393-401.

Kotchen TA. Angiotensinogen genotype and blood pressure responses to reduced dietary NaCl and to weight loss. Hypertension. 1998 Sep;32(3):402-3. No abstract available.

Cook NR, Kumanyika SK, Cutler JA. 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. 1998 Sep 1;148(5):431-44.

Cook NR. An imputation method for non-ignorable missing data in studies of blood pressure. Stat Med. 1997 Dec 15;16(23):2713-28.

Batey DM, Kaufmann PG, Raczynski JM, Hollis JF, Murphy JK, Rosner B, Corrigan SA, Rappaport NB, Danielson EM, Lasser NL, Kuhn CM. Stress management intervention for primary prevention of hypertension: detailed results from Phase I of Trials of Hypertension Prevention (TOHP-I). Ann Epidemiol. 2000 Jan;10(1):45-58.

Hollis JF, Satterfield S, Smith F, Fouad M, Allender PS, Borhani N, Charleston J, Hirlinger M, King N, Schultz R, et al. 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. 1995 Mar;5(2):140-8.

Stevens VJ, Obarzanek E, Cook NR, Lee IM, Appel LJ, Smith West D, Milas NC, Mattfeldt-Beman M, Belden L, Bragg C, Millstone M, Raczynski J, Brewer A, Singh B, Cohen J. Long-term weight loss and changes in blood pressure: results of the Trials of Hypertension Prevention, phase II. Ann Intern Med. 2001 Jan 2;134(1):1-11.

Kumanyika SK, Cook NR, Cutler JA, Belden L, Brewer A, Cohen JD, Hebert PR, Lasser VI, Raines J, Raczynski J, Shepek L, Diller L, Whelton PK, Yamamoto M; Trials of Hypertension Prevention Collaborative Research Group. Sodium reduction for hypertension prevention in overweight adults: further results from the Trials of Hypertension Prevention Phase II. J Hum Hypertens. 2005 Jan;19(1):33-45.

Cook NR, Kumanyika SK, Cutler JA, Whelton PK; Trials of Hypertension Prevention Collaborative Research Group. Dose-response of sodium excretion and blood pressure change among overweight, nonhypertensive adults in a 3-year dietary intervention study. J Hum Hypertens. 2005 Jan;19(1):47-54.

Study ID Numbers:	47
Study First Received:	October 27, 1999
Last Updated:	January 3, 2006
ClinicalTrials.gov Identifier:	NCT00000528 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Heart Diseases
Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on November 25, 2009