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Completed

NCT Number: NCT04361877

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Munich (LMU Klinikum)

Munich, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy adults over 18 years

Exclusion criteria

any condition that does not allow physical activity

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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