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

Cardiovascular Prevention Behaviour Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04361877
• Other study ID #: 20-268 KB
• Status: Completed
• Start date: March 30, 2020
• Est. completion date: April 20, 2020

Study information

• Verified date: May 2021
• Source: Klinikum der Universitaet Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1900
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

healthy adults over 18 years

Exclusion Criteria:

any condition that does not allow physical activity

Related Conditions & MeSH terms

• Cardiovascular Prevention Behaviour

Locations

Country	Name	City	State
Germany	University Hospital Munich (LMU Klinikum)	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of physical activity	Questionnaire, 3 level scale ranging from less activity (Level 1), unchanged activity (Level 2), to increased activity (Level 3)	14 days
Secondary	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)	14 days
Secondary	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)	14 days
Secondary	change of smoking behaviour	Questionnaire, 3 level scale ranging from less smoking(Level 1), unchanged smoking (Level 2), to increased smoking (Level 3)	14 days
Secondary	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)	14 days
Secondary	step count	wearables	6 days