- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04432038
Healthy Lifestyle or Pro-health Obsession During the Pandemic
April 7, 2021 updated by: Gdansk University of Physical Education and Sport
Healthy Lifestyle or Pro-health Obsession During the Pandemic - a Multinational Study
Citizens of many countries are in the high peak period of the outbreak of the COVID-19 virus.
People are currently struggling with the total cessation of certain aspects of normal life.
The situation associated with the pandemic can lead to the development of many problems connected both with mental and physical health.
The investigators, as psychologists, would like to better understand this difficult situation and identify mechanisms which can lead to health problems.
Therefore, group of researchers and practitioners created this study to investigate how people in general cope with this critical situation.
The researchers would like to estimate the following variables which participants will evaluate before and during the pandemic period: levels of physical activity, attitudes towards one's body, attitudes towards eating, and psychological well-being.
The investigators would like to involve experts and scientists from all around the world.
Through this research and by investigating how people cope with this critical situation the solutions for psychological care and interventions for global crisis situations like the COVID-19 pandemic might be identified.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
50000
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
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Gdańsk, Poland, 80-336
- Recruiting
- Gdansk University of Physical Education and Sport
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Contact:
- Mariusz Lipowski, prof.
- Email: mariusz.lipowski@awf.gda.pl
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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
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The investigators will approach individuals from Bangladesh, Brazil, China, Croatia, Ethiopia, France, Germany, Indonesia, Iran, Italy, Lithuania, Nigeria, Norway, Pakistan, Portugal, Romania, South Africa, Spain, Sri Lanka, USA, Vietnam
Description
Inclusion Criteria:
- Age: min 18 years old
Exclusion Criteria:
- no
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
Cohorts and Interventions
Group / Cohort |
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General population of adults from about 30 countries
Data will be collected in general population of adults from about 30 countries.
Questionnaires contain also questions about the occurrence of chronic illnesses, being a professional athlete, etc. to control all such aspects.
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General population of adults from Poland
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General population of adults from Germany
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General population of adults from China
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General population of adults from Vietnam
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General population of adults from Spain
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General population of adults from Brazil
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General population of adults from Croatia
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General population of adults from Ethiopia
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General population of adults from France
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General population of adults from Indonesia
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General population of adults from Iran
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General population of adults from Sri Lanka
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General population of adults from USA
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General population of adults from Italy
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General population of adults from South Africa
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General population of adults from Portugal
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General population of adults from Norway
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General population of adults from Lithuania
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General population of adults from Romania
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General population of adults from Pakistan
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General population of adults from Ukraine
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General population of adults from India
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General population of adults from Japan
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General population of adults from Russia
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General population of adults from Bangladesh
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General population of adults from Nigeria
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General population of adults from Egypt
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Levels of Physical Activity
Time Frame: Baseline
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measured by Inventory of Physical Activity Objectives (IPAO) by Lipowski & Zaleski is used to examine the motivating function of objectives determining one to undertake physical activity.
The respondent answers questions regarding his/her involvement in competitive sports (both present and previous), and forms and intensity of his/her physical activity.
The survey allows analyzing objectives in terms of their dimensions (importance, expectations, conflict), as well as dimensions of action (exercise, endurance, satisfaction).
The respondent is given a (multiple) choice of objectives behind his/her physical activity.
Four scales of goal-oriented behaviours associated with PA are distinguished in the test: motivational value, time management, persistence in action, motivational conflict.
The higher the results of these scales - the higher the motivation to physical activity.
IPAO is characterized by good psychometric properties, the Cronbach's α for IPAO reached 0,78.
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Baseline
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Eating Attitudes
Time Frame: Baseline
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measured by Eating Attitudes Test (EAT-26) by Garner, Olmsted, Bohr & Garfinkel (1982).
It's a self-report measure of symptoms and concerns characteristic of eating disorders.
The EAT-26 can be used in a non-clinical as well as a clinical setting not specifically focused on eating disorders.
Questionnaire is rated on a six-point scale based on how often the individual engages in specific behaviors.
Scores greater than 20 indicate a need for further investigation by a qualified professional.
Research using different EAT-26 language versions has a satisfactory Crombach's alpha 0,78-0,92.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Psychological wellbeing
Time Frame: Baseline
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measured by Psychological Well-Being Scales (PWBS) by Ryff (2004).
The PWB scales incorporate six dimensions: autonomy, positive relations with others, environmental mastery, personal growth, purpose in life and self-acceptance.
Respondents rate how strongly they agree or disagree with 18 statements using a 7-point scale, higher scores indicate greater wellbeing.
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Baseline
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Physical wellbeing
Time Frame: Baseline
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measured by SF-12v2 Health Survey, the SF-12v2 is a practical, reliable and valid measure of physical and mental health, it uses just 12 questions.
Higher scores indicate a higher level of physical wellbeing
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Baseline
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Obligatory Exercise
Time Frame: Baseline
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measured by Obligatory Exercise Questionnaire (OEQ) by Pasman & Thompson (1988).
OEQ allows to measure excessive exercise activity, especially as it relates to eating disorders.
The OEQ contains three factors: Emotional Element of Exercise; Exercise Frequency and Intensity; and Exercise Preoccupation.
All items indicate higher endorsement of and engaging in obligatory exercise behaviors.
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Baseline
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Attitudes Towards Body
Time Frame: Baseline
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measured by Sociocultural Attitudes Towards Appearance (SATAQ 3) by Thompson et al (2014) - widely used measure of societal influences on body image and eating disturbances.
SATAQ 3 has subscales that assess internalization (general, athlete), pressures, and information.
Items are rated on a five point response scale, with higher scores indicating greater media endorsement.
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Baseline
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Body Image Disturbance
Time Frame: Baseline
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measured by Fear of Negative Appearance Evaluation Scale (FNAES) developed by Lundgren, Anderson &Thompson (2004) - an eight-item self-report measure that assesses apprehension about appearance evaluation.
The higher the FNEAS score the more fear of negative appearance evaluation by others is experienced.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
General Publications
- Ryff CD. Psychological well-being revisited: advances in the science and practice of eudaimonia. Psychother Psychosom. 2014;83(1):10-28. doi: 10.1159/000353263. Epub 2013 Nov 19.
- Garner DM, Olmsted MP, Bohr Y, Garfinkel PE. The eating attitudes test: psychometric features and clinical correlates. Psychol Med. 1982 Nov;12(4):871-8. doi: 10.1017/s0033291700049163.
- Thompson JK, van den Berg P, Roehrig M, Guarda AS, Heinberg LJ. The sociocultural attitudes towards appearance scale-3 (SATAQ-3): development and validation. Int J Eat Disord. 2004 Apr;35(3):293-304. doi: 10.1002/eat.10257.
- Lundgren JD, Anderson DA, Thompson JK. Fear of negative appearance evaluation: development and evaluation of a new construct for risk factor work in the field of eating disorders. Eat Behav. 2004 Jan;5(1):75-84. doi: 10.1016/S1471-0153(03)00055-2.
- Li K, Walczak-Kozlowska T, Lipowski M, Li J, Krokosz D, Su Y, Yu H, Fan H. The effect of the Baduanjin exercise on COVID-19-related anxiety, psychological well-being and lower back pain of college students during the pandemic. BMC Sports Sci Med Rehabil. 2022 Jun 8;14(1):102. doi: 10.1186/s13102-022-00493-3.
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)
June 19, 2020
Primary Completion (ANTICIPATED)
June 19, 2021
Study Completion (ANTICIPATED)
June 30, 2021
Study Registration Dates
First Submitted
June 7, 2020
First Submitted That Met QC Criteria
June 13, 2020
First Posted (ACTUAL)
June 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 9, 2021
Last Update Submitted That Met QC Criteria
April 7, 2021
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GdanskUPES
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.
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