NCT00000535

Brief Summary

To test the efficacy of weight loss and sodium restriction, alone and combined, in maintaining the normotensive state following withdrawal of antihypertensive medications in an elderly cohort. Conducted in collaboration with the National Institute on Aging.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1992

Geographic Reach
1 country

4 active sites

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

April 1, 1992

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1997

Completed
2.7 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 7, 2016

Status Verified

October 1, 2002

First QC Date

October 27, 1999

Last Update Submit

November 4, 2016

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionVascular Diseases

Interventions

diet, reducingBEHAVIORAL
diet, sodium-restrictedBEHAVIORAL

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women with a systolic blood pressure of less than 145 mm Hg and diastolic blood pressure of less than 85 mm Hg on single-drug therapy.

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

Sponsors & Collaborators

Study Sites (4)

Johns Hopkins University

Baltimore, Maryland, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Location

Bowman Gray School of Medicine

Winston-Salem, North Carolina, United States

Location

University of Tennessee

Memphis, Tennessee, United States

Location

Related Publications (12)

  • Appel LJ, Espeland M, Whelton PK, Dolecek T, Kumanyika S, Applegate WB, Ettinger WH Jr, Kostis JB, Wilson AC, Lacy C, et al. Trial of Nonpharmacologic Intervention in the Elderly (TONE). Design and rationale of a blood pressure control trial. Ann Epidemiol. 1995 Mar;5(2):119-29. doi: 10.1016/1047-2797(94)00056-y.

    PMID: 7795830BACKGROUND

  • Espeland MA, Kumanyika S, Kostis JB, Algire J, Applegate WB, Ettinger W, Whelton PK, Bahnson J. Antihypertensive medication use among recruits for the Trial of Nonpharmacologic Interventions in the Elderly (TONE). J Am Geriatr Soc. 1996 Oct;44(10):1183-9. doi: 10.1111/j.1532-5415.1996.tb01367.x.

    PMID: 8855996BACKGROUND

  • Whelton PK, Appel LJ, Espeland MA, Applegate WB, Ettinger WH Jr, Kostis JB, Kumanyika S, Lacy CR, Johnson KC, Folmar S, Cutler JA. Sodium reduction and weight loss in the treatment of hypertension in older persons: a randomized controlled trial of nonpharmacologic interventions in the elderly (TONE). TONE Collaborative Research Group. JAMA. 1998 Mar 18;279(11):839-46. doi: 10.1001/jama.279.11.839.

    PMID: 9515998BACKGROUND

  • Whelton PK, Babnson J, Appel LJ, Charleston J, Cosgrove N, Espeland MA, Folmar S, Hoagland D, Krieger S, Lacy C, Lichtermann L, Oates-Williams F, Tayback M, Wilson AC. Recruitment in the Trial of Nonpharmacologic Intervention in the Elderly (TONE). J Am Geriatr Soc. 1997 Feb;45(2):185-93. doi: 10.1111/j.1532-5415.1997.tb04505.x.

    PMID: 9033517BACKGROUND

  • Kostis JB, Espeland MA, Appel L, Johnson KC, Pierce J, Wofford JL. Does withdrawal of antihypertensive medication increase the risk of cardiovascular events? Trial of Nonpharmacologic Interventions in the Elderly (TONE) Cooperative Research Group. Am J Cardiol. 1998 Dec 15;82(12):1501-8. doi: 10.1016/s0002-9149(98)00694-8.

    PMID: 9874055BACKGROUND

  • Kostis JB, Wilson AC, Shindler DM, Cosgrove NM, Lacy CR. Persistence of normotension after discontinuation of lifestyle intervention in the trial of TONE. Trial of Nonpharmacologic Interventions in the Elderly. Am J Hypertens. 2002 Aug;15(8):732-4. doi: 10.1016/s0895-7061(02)02942-4.

    PMID: 12160197BACKGROUND

  • Kostis JB, Wilson AC, Hooper WC, Harrison KW, Philipp CS, Appel LJ, Espeland MA, Folmar S, Johnson KC; TONE Cooperative Research Group. Trial Of Nonpharmacologic interventions in the Elderly. Association of angiotensin-converting enzyme DD genotype with blood pressure sensitivity to weight loss. Am Heart J. 2002 Oct;144(4):625-9. doi: 10.1067/mhj.2002.123570.

    PMID: 12360157BACKGROUND

  • Kumanyika SK, Espeland MA, Bahnson JL, Bottom JB, Charleston JB, Folmar S, Wilson AC, Whelton PK; TONE Cooperative Research Group. Ethnic comparison of weight loss in the Trial of Nonpharmacologic Interventions in the Elderly. Obes Res. 2002 Feb;10(2):96-106. doi: 10.1038/oby.2002.16.

    PMID: 11836455BACKGROUND

  • Appel LJ, Espeland MA, Easter L, Wilson AC, Folmar S, Lacy CR. Effects of reduced sodium intake on hypertension control in older individuals: results from the Trial of Nonpharmacologic Interventions in the Elderly (TONE). Arch Intern Med. 2001 Mar 12;161(5):685-93. doi: 10.1001/archinte.161.5.685.

    PMID: 11231700BACKGROUND

  • Juraschek SP, Cluett JL, Belanger MJ, Anderson TS, Ishak A, Sahni S, Millar C, Appel LJ, Miller ER, Lipsitz LA, Mukamal KJ. Effects of Antihypertensive Deprescribing Strategies on Blood Pressure, Adverse Events, and Orthostatic Symptoms in Older Adults: Results From TONE. Am J Hypertens. 2022 Apr 2;35(4):337-346. doi: 10.1093/ajh/hpab171.

    PMID: 34718403DERIVED

  • Chen L, Zhang Z, Chen W, Whelton PK, Appel LJ. Lower Sodium Intake and Risk of Headaches: Results From the Trial of Nonpharmacologic Interventions in the Elderly. Am J Public Health. 2016 Jul;106(7):1270-5. doi: 10.2105/AJPH.2016.303143. Epub 2016 Apr 14.

    PMID: 27077348DERIVED

  • Shea MK, Nicklas BJ, Houston DK, Miller ME, Davis CC, Kitzman DW, Espeland MA, Appel LJ, Kritchevsky SB. The effect of intentional weight loss on all-cause mortality in older adults: results of a randomized controlled weight-loss trial. Am J Clin Nutr. 2011 Sep;94(3):839-46. doi: 10.3945/ajcn.110.006379. Epub 2011 Jul 20.

    PMID: 21775558DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionVascular Diseases

Interventions

Diet, ReducingDiet, Sodium-Restricted

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Walter Ettinger

    Bowman Gray School of Medicine

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

April 1, 1992

Study Completion

March 1, 1997

Last Updated

November 7, 2016

Record last verified: 2002-10

Locations

US(4)