AdultNCT04432038
Healthy Lifestyle or Pro-health Obsession During the Pandemic
An observational study of Adult and Global Health, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult, Global Health
- How many people
- 50,000 participants
- Where
- 1 sitePoland
- Study dates
- 19 Jun 2020to 30 Jun 2021
- 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
- Adult, Older adult
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
Who may be able to join
- Age: min 18 years old
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Gdansk University of Physical Education and Sport
Gdansk, 80-336
Mariusz Lipowski, prof., mariusz.lipowski@awf.gda.pl
About this study
Official title: 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.
- Conditions
- Adult, Global Health
- Keywords
- COVID-19, well-being, physical activity, nutrition, body image
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| General population of adults from Poland | Not described | |
| General population of adults from Germany | Not described | |
| General population of adults from China | Not described | |
| General population of adults from Vietnam | Not described | |
| General population of adults from Spain | Not described | |
| General population of adults from Brazil | Not described | |
| General population of adults from Croatia | Not described | |
| General population of adults from Ethiopia | Not described | |
| General population of adults from France | Not described | |
| General population of adults from Indonesia | Not described | |
| General population of adults from Iran | Not described | |
| General population of adults from Sri Lanka | Not described | |
| General population of adults from USA | Not described | |
| General population of adults from Italy | Not described | |
| General population of adults from South Africa | Not described | |
| General population of adults from Portugal | Not described | |
| General population of adults from Norway | Not described | |
| General population of adults from Lithuania | Not described | |
| General population of adults from Romania | Not described | |
| General population of adults from Pakistan | Not described | |
| General population of adults from Ukraine | Not described | |
| General population of adults from India | Not described | |
| General population of adults from Japan | Not described | |
| General population of adults from Russia | Not described | |
| General population of adults from Bangladesh | Not described | |
| General population of adults from Nigeria | Not described | |
| General population of adults from Egypt | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Physical Activity
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.
Measured: Baseline
Eating Attitudes
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.
Measured: Baseline
Secondary outcomes (5)
Psychological wellbeing
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.
Measured: Baseline
Physical wellbeing
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
Measured: Baseline
Obligatory Exercise
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.
Measured: Baseline
Attitudes Towards Body
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.
Measured: Baseline
Body Image Disturbance
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start19 Jun 2020
- Primary completion19 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AdultStudies 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
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Split, University of Gondar, Universidad Pablo de Olavide, Universitas Padjadjaran, University of Social Welfare and Rehabilitation Science, DPFA Academy of Work and Health, Leipzig, Instituto Piaget, University of Peradeniya, Catholic University of the Sacred Heart, University of Évora, Norwegian School of Sport Sciences, Klaipėda University, Universitatea Alexandru Ioan Cuza, Institut Catholique de Paris, University of Gdansk, Jagiellonian University, International University of Business Agriculture and Technology, Beijing Sport University, University of Nigeria, Enugu Campus, University of Sargodha, University of Brasilia, Wright State University, Vietnam National University, Taras Shevchenko National University of Kyiv, Astana Medical University, International Islamic Academy of Uzbekistan, Menoufia University, Zhengzhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432038
- Sponsor's protocol ID
- GdanskUPES
- Status last verified
- Jun 2020
- First submitted
- 7 Jun 2020
- Last updated
- 9 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 6961471Thompson 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.
PubMed 15048945Lundgren 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.
PubMed 15000956Ryff 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.
PubMed 24281296Li 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.
PubMed 35676708
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Lifestyle or Pro-health Obsession During the Pandemic - a Multinational Study
- ClinicalTrials.gov ID
- NCT04432038
- Acronym / sponsor ID
- GdanskUPES
- Conditions
- Adult, Global Health
- Keywords
- COVID-19, well-being, physical activity, nutrition, body image
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Collaborators
- University Hospital of Split, University of Gondar, Universidad Pablo de Olavide, Universitas Padjadjaran, University of Social Welfare and Rehabilitation Science, DPFA Academy of Work and Health, Leipzig, Instituto Piaget, University of Peradeniya, Catholic University of the Sacred Heart, University of Évora, Norwegian School of Sport Sciences, Klaipėda University, Universitatea Alexandru Ioan Cuza, Institut Catholique de Paris, University of Gdansk, Jagiellonian University, International University of Business Agriculture and Technology, Beijing Sport University, University of Nigeria, Enugu Campus, University of Sargodha, University of Brasilia, Wright State University, Vietnam National University, Taras Shevchenko National University of Kyiv, Astana Medical University, International Islamic Academy of Uzbekistan, Menoufia University, Zhengzhou University
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 19 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 16 Jun 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 28
| Arm | Type | Receives |
|---|---|---|
| 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. |
| General population of adults from Poland | – | – |
| General population of adults from Germany | – | – |
| General population of adults from China | – | – |
| General population of adults from Vietnam | – | – |
| General population of adults from Spain | – | – |
| General population of adults from Brazil | – | – |
| General population of adults from Croatia | – | – |
| General population of adults from Ethiopia | – | – |
| General population of adults from France | – | – |
| General population of adults from Indonesia | – | – |
| General population of adults from Iran | – | – |
| General population of adults from Sri Lanka | – | – |
| General population of adults from USA | – | – |
| General population of adults from Italy | – | – |
| General population of adults from South Africa | – | – |
| General population of adults from Portugal | – | – |
| General population of adults from Norway | – | – |
| General population of adults from Lithuania | – | – |
| General population of adults from Romania | – | – |
| General population of adults from Pakistan | – | – |
| General population of adults from Ukraine | – | – |
| General population of adults from India | – | – |
| General population of adults from Japan | – | – |
| General population of adults from Russia | – | – |
| General population of adults from Bangladesh | – | – |
| General population of adults from Nigeria | – | – |
| General population of adults from Egypt | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Age: min 18 years old
Key exclusion criteria (1 listed)
- no
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
Levels of Physical Activity
Time frame: Baseline
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.
Eating Attitudes
Time frame: Baseline
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.
5 secondary outcomes
Psychological wellbeing
Time frame: Baseline
Physical wellbeing
Time frame: Baseline
Obligatory Exercise
Time frame: Baseline
Attitudes Towards Body
Time frame: Baseline
Body Image Disturbance
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Background: PubMed 6961471Garner 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.
- Background: PubMed 15048945Thompson 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.
- Background: PubMed 15000956Lundgren 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.
- Background: PubMed 24281296Ryff 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.
- Derived from this study: PubMed 35676708Li 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.
- Lipowski, M., Zaleski, Z. (2015). Inventory of Physical Activity Objectives (IPAO) - a new method in measuring motives for physical activity and sport. Health Psychology Report, 3(1), 47-58Link provided by the sponsor.
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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.
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 Adult and Global Health, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
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: status not confirmed, as of the sponsor's last update on 9 Apr 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariusz Lipowski, Prof. (0048 501 128 554, mariusz.lipowski@awf.gda.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of Physical Activity (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT04432038, which also lists 5 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 9 Apr 2021.