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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01208844
Other study ID # CPS06230812Exp.
Secondary ID 1R15HL085121-01A
Status Completed
Phase N/A
First received August 30, 2010
Last updated April 27, 2015
Start date June 2008
Est. completion date August 2012

Study information

Verified date April 2015
Source Nova Southeastern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to obtain a better understanding of how stress is related to health risks.


Description:

Participants complete up to two study visits of approximately 3-4 hours each. The first study visit involves an interview about life experiences and emotions. If the participant is eligible for the second assessment, the average length of time between visit 1 and visit 2 will be 1-7 days. The second visit included physical measurements such as cholesterol and blood pressure, performing math and speaking tasks, and surveys to help us learn about healthy behaviors and emotions. No further follow-up of participants is conducted beyond the two study visits.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Pre-menopausal

- Must be able to speak and read English fluently

Exclusion Criteria:

- Specific medications and chronic diseases

- History of heart attack (myocardial infarction)

- Pregnant or given birth in last 3 months

- Peri-menopausal or post-menopausal

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
United States Center for Psychological Studies, Nova Southeastern University Fort Lauderdale Florida

Sponsors (2)

Lead Sponsor Collaborator
Nova Southeastern University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Cardiovascular Risk Factors This primary outcome will be assessed at the second study visit (1-7 days from first study visit for those who are eligible). Single assessment timepoint No
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