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Prehypertension Labeling

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Columbia University.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Columbia University Identifier:
First received: September 8, 2011
Last updated: September 14, 2011
Last verified: September 2011
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.

Condition Intervention
Behavioral: Labeled prehypertension
Behavioral: Unlabeled prehypertension

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Screening
Official Title: Diagnostic Labeling: Effect on White Coat Hypertension

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in blood pressure [ Time Frame: Baseline, 3 months ]

Secondary Outcome Measures:
  • Change in health-related quality of life (SF-12 questionnaires) [ Time Frame: Baseline, 3 months ]

Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Labeled Behavioral: Labeled 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.
Active Comparator: Unlabeled Behavioral: Unlabeled prehypertension
A study physician informs subjects of their blood pressure level. The term "prehypertension" is not used and associated health risks are not discussed.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01434953

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: Tanya Goyal Columbia University
  More Information

Responsible Party: Columbia University Identifier: NCT01434953     History of Changes
Other Study ID Numbers: AAAC6382
Study First Received: September 8, 2011
Last Updated: September 14, 2011

Keywords provided by Columbia University:
Blood pressure screening
White coat effect

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on May 25, 2017