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

May 4, 2021 updated by: PD Dr. Stefan Brunner, LMU Klinikum
The study aims to determine the impact of COVID-19 pandemic lockdown on cardiovascular prevention behaviour.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

1900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Munich, Germany
        • University Hospital Munich (LMU Klinikum)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy adults over 18 years

Description

Inclusion Criteria:

healthy adults over 18 years

Exclusion Criteria:

any condition that does not allow physical activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2020

Primary Completion (Actual)

April 20, 2020

Study Completion (Actual)

April 20, 2020

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Cardiovascular Prevention Behaviour

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