- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04361877
Cardiovascular Prevention During COVID-19 Pandemic Lockdown in Young Adults (COLA Trial)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Munich, Germany
- University Hospital Munich (LMU Klinikum)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
healthy adults over 18 years
Exclusion Criteria:
any condition that does not allow physical activity
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
14 days
|
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)
|
14 days
|
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)
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14 days
|
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)
|
14 days
|
step count
Time Frame: 6 days
|
wearables
|
6 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Steffen J, Schlichtiger J, Huber BC, Brunner S. Altered alcohol consumption during COVID-19 pandemic lockdown. Nutr J. 2021 May 11;20(1):44. doi: 10.1186/s12937-021-00699-0.
- Huber BC, Steffen J, Schlichtiger J, Brunner S. Altered nutrition behavior during COVID-19 pandemic lockdown in young adults. Eur J Nutr. 2021 Aug;60(5):2593-2602. doi: 10.1007/s00394-020-02435-6. Epub 2020 Dec 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-268 KB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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