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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04432038
Other study ID # GdanskUPES
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 19, 2020
Est. completion date June 30, 2021

Study information

Verified date June 2020
Source Gdansk University of Physical Education and Sport
Contact Mariusz Lipowski, Prof.
Phone 0048 501 128 554
Email mariusz.lipowski@awf.gda.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50000
Est. completion date June 30, 2021
Est. primary completion date June 19, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age: min 18 years old Exclusion Criteria: - no

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Poland Gdansk University of Physical Education and Sport Gdansk

Sponsors (29)

Lead Sponsor Collaborator
Gdansk University of Physical Education and Sport Astana Medical University, Beijing Sport Uninversity, Catholic University of the Sacred Heart, DPFA Academy of Work and Health, Leipzig, Institut Catholique de Paris, Instituto Piaget, International Islamic Academy of Uzbekistan, International University of Business Agriculture and Technology, Jagiellonian University, Klaipeda University, Menoufia University, Norwegian School of Sport Sciences, Taras Shevchenko National University of Kyiv, Universidad Pablo de Olavide, Universitas Padjadjaran, Universitatea Alexandru Ioan Cuza, University Hospital of Split, University of Brasilia, University of Évora, University of Gdansk, University of Gondar, University of Nigeria, Enugu Campus, University of Peradeniya, University of Sargodha, University of Social Welfare and Rehabilitation Science, Vietnam National University, Wright State University, Zhengzhou University

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 a for IPAO reached 0,78. Baseline
Primary 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. Baseline
Secondary 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. Baseline
Secondary 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 Baseline
Secondary 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. Baseline
Secondary 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. Baseline
Secondary 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. Baseline
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