Cardiovascular Prevention BehaviourNCT04361877
Cardiovascular Prevention During COVID-19 Pandemic Lockdown in Young Adults (COLA Trial)
An observational study of Cardiovascular Prevention Behaviour, run by LMU Klinikum at 1 site in Germany.
Trial summary
The study aims to determine the impact of COVID-19 pandemic lockdown on cardiovascular prevention behaviour. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Prevention Behaviour
- How many people
- 1,900 participants
- Where
- 1 siteGermany
- Study dates
- 30 Mar 2020to 20 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy adults over 18 years
Who may be able to join
- healthy adults over 18 years
Who cannot join
- any condition that does not allow physical activity
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to determine the impact of COVID-19 pandemic lockdown on cardiovascular prevention behaviour.
Read the 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.
- Conditions
- Cardiovascular Prevention Behaviour
- Keywords
- COVID-19, cardiovascular prevention, physical exercise, risk factor, nutrition
- Medical subject headings
- COVID-19, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of physical activity
Questionnaire, 3 level scale ranging from less activity (Level 1), unchanged activity (Level 2), to increased activity (Level 3)
Measured: 14 days
Secondary outcomes (5)
change of nutrition behaviour
Questionnaire, 3 level scale ranging from less food intake (Level 1), unchanged food intake (Level 2), to increased food intake (Level 3)
Measured: 14 days
semiquantitative change of alcohol intake
Questionnaire, 3 level scale ranging from less alcohol intake (Level 1), unchanged alcohol intake (Level 2), to increased alcohol intake (Level 3)
Measured: 14 days
change of smoking behaviour
Questionnaire, 3 level scale ranging from less smoking(Level 1), unchanged smoking (Level 2), to increased smoking (Level 3)
Measured: 14 days
change of stress level
Questionnaire, 3 level scale ranging from lower stress level (Level 1), unchanged stress level (Level 2), to increased stress level (Level 3)
Measured: 14 days
step count
wearables
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start30 Mar 2020
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Prevention BehaviourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Stefan Brunner, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361877
- Sponsor's protocol ID
- 20-268 KB
- Status last verified
- May 2021
- First submitted
- 20 Apr 2020
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33975597Huber 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.
PubMed 33258996
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Prevention During COVID-19 Pandemic Lockdown in Young Adults (COLA Trial)
- ClinicalTrials.gov ID
- NCT04361877
- Acronym / sponsor ID
- 20-268 KB
- Conditions
- Cardiovascular Prevention Behaviour
- Keywords
- COVID-19, cardiovascular prevention, physical exercise, risk factor, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to determine the impact of COVID-19 pandemic lockdown on 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adults over 18 years
Key inclusion criteria (1 listed)
- healthy adults over 18 years
Key exclusion criteria (1 listed)
- any condition that does not allow physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
5 secondary outcomes
change of nutrition behaviour
Time frame: 14 days
semiquantitative change of alcohol intake
Time frame: 14 days
change of smoking behaviour
Time frame: 14 days
change of stress level
Time frame: 14 days
step count
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Derived from this study: PubMed 33975597Steffen 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.
- Derived from this study: PubMed 33258996Huber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Prevention Behaviour, run by LMU Klinikum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of physical activity (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04361877, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.