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Cardiovascular Prevention During COVID-19 Pandemic Lockdown in Young Adults (COLA Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361877
Recruitment Status : Completed
First Posted : April 24, 2020
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
PD Dr. Stefan Brunner, Klinikum der Universitaet Muenchen

Brief Summary:
The study aims to determine the impact of COVID-19 pandemic lockdown on cardiovascular prevention behaviour.

Condition or disease
Cardiovascular Prevention Behaviour

Detailed Description:

The COVID-19 pandemic resulted in a lockdown and social distancing in most countries all over the world. The impact of this national intervention on cardiovascular prevention behaviour (physical exercise, nutrition, smoking) is unknown. The COLA Trial aims to help clarifying these questions.

An online survey was distributed among bavarian students with standardized questions about physical activity, nutritional behavior, smoking and alcohol intake before and during lockdown.

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Study Type : Observational
Actual Enrollment : 1900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Prevention During COVID-19 Pandemic Lockdown in Young Adults (COLA Trial)
Actual Study Start Date : March 30, 2020
Actual Primary Completion Date : April 20, 2020
Actual Study Completion Date : April 20, 2020



Primary Outcome Measures :
  1. Change of physical activity [ Time Frame: 14 days ]
    Questionnaire, 3 level scale ranging from less activity (Level 1), unchanged activity (Level 2), to increased activity (Level 3)


Secondary Outcome Measures :
  1. change of nutrition behaviour [ Time Frame: 14 days ]
    Questionnaire, 3 level scale ranging from less food intake (Level 1), unchanged food intake (Level 2), to increased food intake (Level 3)

  2. semiquantitative change of alcohol intake [ Time Frame: 14 days ]
    Questionnaire, 3 level scale ranging from less alcohol intake (Level 1), unchanged alcohol intake (Level 2), to increased alcohol intake (Level 3)

  3. change of smoking behaviour [ Time Frame: 14 days ]
    Questionnaire, 3 level scale ranging from less smoking(Level 1), unchanged smoking (Level 2), to increased smoking (Level 3)

  4. change of stress level [ Time Frame: 14 days ]
    Questionnaire, 3 level scale ranging from lower stress level (Level 1), unchanged stress level (Level 2), to increased stress level (Level 3)

  5. step count [ Time Frame: 6 days ]
    wearables



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy adults over 18 years
Criteria

Inclusion Criteria:

healthy adults over 18 years

Exclusion Criteria:

any condition that does not allow physical activity


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361877


Locations
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Germany
University Hospital Munich (LMU Klinikum)
Munich, Germany
Sponsors and Collaborators
Klinikum der Universitaet Muenchen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PD Dr. Stefan Brunner, Attending, Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier: NCT04361877    
Other Study ID Numbers: 20-268 KB
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PD Dr. Stefan Brunner, Klinikum der Universitaet Muenchen:
COVID-19
cardiovascular prevention
physical exercise
risk factor
nutrition