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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychological wellbeing
Time Frame: Baseline
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.
Baseline
Physical wellbeing
Time Frame: Baseline
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
Baseline
Obligatory Exercise
Time Frame: Baseline
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.
Baseline
Attitudes Towards Body
Time Frame: Baseline
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.
Baseline
Body Image Disturbance
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gdansk University of Physical Education and Sport

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Brasilia
Jagiellonian University
Klaipėda University
Catholic University of the Sacred Heart
Menoufia University
Zhengzhou University
Norwegian School of Sport Sciences
Universitas Padjadjaran
Wright State University
University of Social Welfare and Rehabilitation Science
University Hospital of Split
Vietnam National University
University of Évora
University of Sargodha
University of Nigeria, Enugu Campus
Astana Medical University
Instituto Piaget
University of Gondar
University of Peradeniya
Taras Shevchenko National University of Kyiv
University of Gdansk
Universidad Pablo de Olavide
Beijing Sport Uninversity
DPFA Academy of Work and Health, Leipzig
Universitatea Alexandru Ioan Cuza
Institut Catholique de Paris
International University of Business Agriculture and Technology
International Islamic Academy of Uzbekistan

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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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