Trials of Hypertension Prevention (TOHP)

NCT00000528 | Completed Phase 3

• 2 other identifiers: 47U01HL037852
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Interventions

diet, sodium-restricted (Phase III) diet, sodium-restricted BEHAVIORAL

diet, reducing (Phase III) BEHAVIORAL

Eligibility Criteria

• Age: 30 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (30)

• Kumanyika SK, Obarzanek E, Stevens VJ, Hebert PR, Whelton PK, Kumanyaka SK. Weight-loss experience of black and white participants in NHLBI-sponsored clinical trials. Am J Clin Nutr. 1991 Jun;53(6 Suppl):1631S-1638S. doi: 10.1093/ajcn/53.6.1631S.

  PMID: 2031498 BACKGROUND

• Rosner B, Langford HG. Judging the effectiveness of antihypertensive therapy in an individual patient. J Clin Epidemiol. 1991;44(8):831-8. doi: 10.1016/0895-4356(91)90138-y.

  PMID: 1941036 BACKGROUND

• 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. doi: 10.1016/1047-2797(92)90062-u.

  PMID: 1342280 BACKGROUND

• 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. doi: 10.1001/jama.1992.03480090061028.

  PMID: 1586398 BACKGROUND

• 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. doi: 10.1161/01.hyp.22.4.502.

  PMID: 8406655 BACKGROUND

• 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.

  PMID: 8398224 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.aje.a116643.

  PMID: 8333415 BACKGROUND

• 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.

  PMID: 8466377 BACKGROUND

• 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. doi: 10.1016/1047-2797(95)00065-8.

  PMID: 8680612 BACKGROUND

• 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. doi: 10.1016/1047-2797(94)00059-3.

  PMID: 7795833 BACKGROUND

• 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. doi: 10.1016/1047-2797(94)00053-v.

  PMID: 7795836 BACKGROUND

• 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. doi: 10.1016/1047-2797(94)00054-w.

  PMID: 7795837 BACKGROUND

• 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. doi: 10.1016/1047-2797(94)00057-z.

  PMID: 7795831 BACKGROUND

• 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. doi: 10.1016/1047-2797(94)00060-7.

  PMID: 7795834 BACKGROUND

• 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.

  PMID: 7695458 BACKGROUND

• 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. doi: 10.1093/ajcn/65.2.652S.

  PMID: 9022561 BACKGROUND

• 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.

  PMID: 9080920 BACKGROUND

• 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.

  PMID: 9080913 BACKGROUND

• 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. doi: 10.1161/01.hyp.32.3.393.

  PMID: 9740601 BACKGROUND

• Kotchen TA. Angiotensinogen genotype and blood pressure responses to reduced dietary NaCl and to weight loss. Hypertension. 1998 Sep;32(3):402-3. doi: 10.1161/01.hyp.32.3.402. No abstract available.

  PMID: 9740602 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.aje.a009668.

  PMID: 9737555 BACKGROUND

• Cook NR. An imputation method for non-ignorable missing data in studies of blood pressure. Stat Med. 1997 Dec 15;16(23):2713-28. doi: 10.1002/(sici)1097-0258(19971215)16:233.0.co;2-s.

  PMID: 9421871 BACKGROUND

• 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. doi: 10.1016/s1047-2797(99)00041-1.

  PMID: 10658688 BACKGROUND

• 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. doi: 10.1016/1047-2797(94)00058-2.

  PMID: 7795832 BACKGROUND

• 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; Trials for the Hypertension Prevention Research Group. 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. doi: 10.7326/0003-4819-134-1-200101020-00007.

  PMID: 11187414 BACKGROUND

• 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. doi: 10.1038/sj.jhh.1001774.

  PMID: 15372064 BACKGROUND

• 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. doi: 10.1038/sj.jhh.1001775.

  PMID: 15343354 BACKGROUND

• 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. doi: 10.1016/1047-2797(91)90014-4.

  PMID: 1669525 BACKGROUND

• 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.

  PMID: 8021472 BACKGROUND

• Sacks FM, Hebert P, Appel LJ, Borhani NO, Applegate WB, Cohen JD, Cutler JA, Kirchner KA, Kuller LH, Roth KJ, et al. The effect of fish oil on blood pressure and high-density lipoprotein-cholesterol levels in phase I of the Trials of Hypertension Prevention. Trials of Hypertension Prevention Collaborative Research Group. J Hypertens Suppl. 1994;12(7):S23-31.

  PMID: 7769501 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Interventions

Diet; Clinical Trials, Phase III as Topic

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Charles Hennekens

  Brigham and Women's Hospital

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: September 1, 1986
• Study Completion: June 1, 1998
• Last Updated: March 16, 2016

Record last verified: 2005-12