NCT00000501

Brief Summary

To test the feasibility and the efficacy of nutritional interventions in the primary prevention of hypertension in individuals predisposed to the development of hypertension; specifically, to test the hypothesis that reduction of weight and/or decreased sodium intake in obese individuals, or decreased sodium intake with or without increased potassium intake (in men and women, regardless of weight) would prevent the elevation of blood pressure and the incidence of hypertension.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1981

Longer than P75 for phase_2 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1981

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1986

Completed
13.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 26, 2013

Status Verified

April 1, 2012

First QC Date

October 27, 1999

Last Update Submit

November 25, 2013

Conditions

Interventions

Eligibility Criteria

Age25 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Men and women, ages 25 to 49. Diastolic blood pressure between 78 and 89 mm Hg. Free of major disease. Not on a special diet or antihypertensive medication at entry. Some mild to moderately obese subjects.

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

Sponsors & Collaborators

Related Publications (14)

  • Hypertension Prevention Trial Research Group: Hypertension Prevention Trial--First Year Dietary Changes. In Strasser T, Ganten D, (Eds.). Mild Hypertension: From Drug Trials to Practice, New York, Raven Press, 1987.

    BACKGROUND
  • Meinert CL, Borhani NO, Langford HG. Design, methods, and rationale in the Hypertension Prevention Trial. Hypertension Prevention Trial Research Group. Control Clin Trials. 1989 Sep;10(3 Suppl):1S-29S. doi: 10.1016/0197-2456(89)90040-8.

    PMID: 2680271BACKGROUND
  • Borhani NO, Tonascia J, Schlundt DG, Prineas RJ, Jefferys JL. Recruitment in the Hypertension Prevention trial. Hypertension Prevention Trial Research Group. Control Clin Trials. 1989 Sep;10(3 Suppl):30S-39S. doi: 10.1016/0197-2456(89)90041-x.

    PMID: 2680272BACKGROUND
  • Brown KM, Oberman A, Van Natta ML, Forster JL. Baseline characteristics in the Hypertension Prevention Trial. Hypertension Prevention Trial Research Group. Control Clin Trials. 1989 Sep;10(3 Suppl):40S-64S. doi: 10.1016/0197-2456(89)90042-1.

    PMID: 2680273BACKGROUND
  • Jeffery RW, Tonascia S, Bjornson-Benson W, Schlundt DG, Sugars C. Treatment in the Hypertension Prevention Trial. Hypertension Prevention Trial Research Group. Control Clin Trials. 1989 Sep;10(3 Suppl):65S-83S. doi: 10.1016/0197-2456(89)90043-3.

    PMID: 2680274BACKGROUND
  • Prud'homme GJ, Canner PL, Cutler JA. Quality assurance and monitoring in the Hypertension Prevention Trial. Hypertension Prevention Trial Research Group. Control Clin Trials. 1989 Sep;10(3 Suppl):84S-94S. doi: 10.1016/0197-2456(89)90044-5.

    PMID: 2680275BACKGROUND
  • Tonascia J, Donithan M, Tonascia S, et al for the Hypertension Prevention Trial Research Group: Hypertension Prevention Trial: Estimation of 24-hour Sodium and Potassium Excretion from Overnight Urine Collections. Baltimore, Maryland, Department of Biostatistics, Johns Hopkins University, Technical Report 703, 1989.

    BACKGROUND
  • Shah M, Jeffery RW, Hannan PJ, Onstad L. Relationship between socio-demographic and behaviour variables, and body mass index in a population with high-normal blood pressure: Hypertension Prevention Trial. Eur J Clin Nutr. 1989 Sep;43(9):583-96.

    PMID: 2606089BACKGROUND
  • The Hypertension Prevention Trial: three-year effects of dietary changes on blood pressure. Hypertension Prevention Trial Research Group. Arch Intern Med. 1990 Jan;150(1):153-62.

    PMID: 2404477BACKGROUND
  • Jeffery RW, French SA, Schmid TL. Attributions for dietary failures: problems reported by participants in the Hypertension Prevention Trial. Health Psychol. 1990;9(3):315-29. doi: 10.1037//0278-6133.9.3.315.

    PMID: 2187695BACKGROUND
  • Forster JL, Jeffery RW, VanNatta M, Pirie P. Hypertension prevention trial: do 24-h food records capture usual eating behavior in a dietary change study? Am J Clin Nutr. 1990 Feb;51(2):253-7. doi: 10.1093/ajcn/51.2.253.

    PMID: 2407098BACKGROUND
  • Shah M, Jeffery RW, Laing B, Savre SG, Van Natta M, Strickland D. Hypertension Prevention Trial (HPT): food pattern changes resulting from intervention on sodium, potassium, and energy intake. Hypertension Prevention Trial Research Group. J Am Diet Assoc. 1990 Jan;90(1):69-76.

    PMID: 2404050BACKGROUND
  • Schmid TL, Jeffery RW, Onstad L, Corrigan SA. Demographic, knowledge, physiological, and behavioral variables as predictors of compliance with dietary treatment goals in hypertension. Addict Behav. 1991;16(3-4):151-60. doi: 10.1016/0306-4603(91)90007-5.

    PMID: 2063702BACKGROUND
  • Canner PL, Borhani NO, Oberman A, Cutler J, Prineas RJ, Langford H, Hooper FJ. The Hypertension Prevention Trial: assessment of the quality of blood pressure measurements. Am J Epidemiol. 1991 Aug 15;134(4):379-92. doi: 10.1093/oxfordjournals.aje.a116100.

    PMID: 1877599BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionObesityVascular Diseases

Interventions

Diet, Sodium-RestrictedDiet, ReducingPotassium

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMetals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Nemat Borhani

    University of California, Davis

  • Robert Jeffery

    University of Minnesota

  • Herbert Langford

    University of Mississippi Medical Center

  • Albert Oberman

    University of Alabama at Birmingham

  • Ronald Prineas

    University of Minnesota

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1981

Study Completion

August 1, 1986

Last Updated

November 26, 2013

Record last verified: 2012-04