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TerminatedNCT01434953Tanya K23Updated Jul 17, 2017

Prehypertension Labeling

An interventional study of Labeled prehypertension and Unlabeled prehypertension in Prehypertension, sponsored by Columbia University. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-17.

Sponsored by Columbia University · Not applicable, Interventional, and Screening

Why this study was terminated
PI left institution

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jul 2009, registered Sep 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to find out whether labeling adults with prehypertension has negative effects on clinic blood pressure and quality of life 3 months after diagnosis.

Read the detailed description

Previous research has shown that a diagnosis of hypertension is associated with subsequent increases in resting blood pressure, and there is preliminary evidence of a cross-sectional association between hypertension labeling and the white coat effect. The white coat effect may be particularly problematic in prehypertensives, because a small elevation in clinic blood pressure could result in crossing the diagnostic cutoff for hypertension, potentially leading to misdiagnosis and unnecessary treatment. This study will examine effects of prehypertension labeling on clinic and ambulatory blood pressure, and will examine potential psychological mediators of these associations.

02

Conditions studied

  • Prehypertension

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Keywords

  • Prehypertension
  • Blood pressure screening
  • White coat effect
03

In context

Prehypertension

151 studies on the registry are indexed under Prehypertension; 22 are open to participants now.

This study's enrollment of 100 is above the median of 64 across 133 interventional studies indexed under Prehypertension.

Browse Prehypertension studies →

Lead sponsor

Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.

Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • at least 18 years
  • average screening systolic blood pressure of 120-139 mmHg OR diastolic blood pressure of 80-89 mmHg
  • average screening systolic blood pressure below 140 mmHg AND diastolic blood pressure below 90 mmHg
  • able to read and write in English

Exclusion criteria

Exclusion Criteria:

  • past diagnosis of hypertension, prehypertension, or high blood pressure
  • current or past use of antihypertensive medications
  • diabetes
  • renal disease
  • cardiovascular disease
  • current participation in another hypertension-related clinical trial
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Labeled

    Behavioral: Labeled prehypertension

  • Active comparator
    Unlabeled

    Behavioral: Unlabeled prehypertension

Interventions

  • BehavioralLabeled prehypertension

    A study physician informs subjects of their blood pressure level. Subjects are told they have prehypertension and are informed of the associated health risks.

  • BehavioralUnlabeled prehypertension

    A study physician informs subjects of their blood pressure level. The term "prehypertension" is not used and associated health risks are not discussed.

06

What researchers measure

Primary outcomes

  1. Change in blood pressure

    Time frame: Baseline, 3 months

Secondary outcomes

  1. Change in health-related quality of life (SF-12 questionnaires)

    Time frame: Baseline, 3 months

07

Study locations

1 site
  • Columbia University Medical Center
    New York, New York 10032, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01434953
Responsible party
Sponsor
First posted
Sep 15, 2011
Start date
Jul 13, 2009
Primary completion
Jul 9, 2012
Completion
Jul 9, 2012
Last update
Jul 17, 2017

Study contacts

Matthew Burg, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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