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Habits, Orthorexia Nervosa and LIfestyle in STudents (HOLISTic)

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ClinicalTrials.gov Identifier: NCT04252924
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
University of Pavia
University of Foggia
Beirut Arab University
University of Wroclaw
University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca
Universidad Pablo de Olavide
Information provided by (Responsible Party):
Ivana Kolcic, University of Split, School of Medicine

Brief Summary:

Non-communicable diseases (NCDs) compose a substantial proportion of the global burden of diseases, posing a significant challenge in both high-income and low- and middle-income countries. In particular, certain lifestyle-related risk factors, such as unhealthy diet, physical inactivity, smoking, excessive alcohol consumption, and sleep deprivation are the leading risk factors, which place people at an increased risk of developing NCDs. On the other hand, a growing phenomenon of excessive concern about diet and health is emerging, and it is contributing to the development of a novel eating behavior disorder named orthorexia nervosa. According to recent studies, orthorexic behavior is very common among young adults and especially so in health-care professionals.

The main objective of this multi-center study is to explore and compare lifestyle habits among undergraduate medical students and other healthcare-related professions from different countries (Croatia, Lebanon, Italy, Poland, Spain, and Turkey). The goal is to obtain information on the presence of unhealthy habits in order to be able to intervene, offering the information needed for primordial disease prevention in this young and still healthy group of respondents, who are the health educators and role models of the future. The particular importance of this goal is to raise awareness of the problem of the ubiquitously present unhealthy lifestyles. Unfortunately, health-care students are not the exception regarding the prevalence of the unhealthy diet, sedentary behavior, sleep deprivation and high levels of psychological stress. Furthermore, the adoption of unhealthy lifestyle patterns in health-care workers, such as doctors and nurses, will have far-reaching negative consequences, in both their health and their patients' health. The results of this study will be used for identifying the needs and targets for intervention, enabling students to become a pillar of health education for their patients and the population in general.


Condition or disease Intervention/treatment
Habits Health Behavior Diet Habit Sleep Stress Physical Activity Other: lifestyle characteristics

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Prevalence of Healthy Lifestyle in Students in Europe: the Mediterranean Diet, Orthorexia Nervosa, Appropriate Physical Activity, Stress Perception, and Sleep Habits
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : April 20, 2021
Estimated Study Completion Date : April 20, 2021

Group/Cohort Intervention/treatment
students
medical student, dental medicine student, pharmacy student, nursing student, physiotherapy student, dietetics student, kinesiology student, biomedical laboratory techniques student, biomolecular science student, psychology student, economy student, student of maritime sciences
Other: lifestyle characteristics
Exposures of interest: Mediterranean diet, orthorexia nervosa, smoking, physical activity, sleep duration, stress level




Primary Outcome Measures :
  1. the Mediterranean diet adherence [ Time Frame: 1 day ]
    Based on the modern Mediterranean diet pyramid and assessed using the scoring system called Mediterranean Diet Serving Score (MDSS; PubMed ID: 26035442). This score has a minimum value of 0 and a maximum value of 24, where the higher score indicates a better compliance with the Mediterranean diet. Additionally, a cut-off point of 14 and more was proposed to indicate the good adherence to the Mediterranean diet.

  2. moderate to vigorous level of physical activity [ Time Frame: 1 day ]
    Based on self-reported data using a questionnaire called International Physical Activity Questionnaire - Short Form (IPAQ-SF; PubMed ID: 12900694). The MET-min (the metabolic equivalent of task) per week are calculated as: MET level x minutes of activity x events per week. Higher number of MET-min per week denotes higher level of physical activity (a better outcome). Details on the scoring protocol can be found at: https://sites.google.com/site/theipaq/scoring-protocol

  3. sleep duration [ Time Frame: 1 day ]
    Based on self-reported data using a questionnaire (time of going to sleep and waking up)

  4. stress level [ Time Frame: 1 day ]
    Based on self-reported data using a questionnaire called Perceived Stress Scale (PSS; PubMed ID: 6668417). The scale has a minimum score of 0 and a maximum of 40, where higher score indicates higher perceived stress during last month.


Secondary Outcome Measures :
  1. Orthorexia nervosa [ Time Frame: 1 day ]
    Based on self-reported data using the questionnaire the Eating Habits Questionnaire (EHQ). The scale has a minimum score of 21, and a maximum score of 84, where higher score indicates higher orthorexic symptoms. Additionally, the scale has three sub scales: knowledge of healthy eating, problems associated with healthy eating, and feeling positively about healthy eating.

  2. Orthorexia nervosa [ Time Frame: 1 day ]
    Based on self-reported data using the Orthorexia nervosa questionnaire (ORTO-15; PubMed ID: 16682853). ORTO-15 has a minimum score of 15 and a maximum of 60, where lower score denotes higher orthorexic symptoms, and the cut-off value of <40 has been proposed to indicate higher probability for the presence of orthorexia.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population includes the overall student population from the following universities:

University of Split (Split, Croatia), University of Pavia (Pavia, Italy), University of Foggia (Foggia, Italy), Koc University (Istanbul, Turkey), Beirut Arab University (Beirut, Lebanon), University of Social Sciences and Humanities (Katowice, Poland), University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca (Cluj-Napoca, Romania), Universidad Pablo De Olavide (Sevilla, Spain)

Criteria

Inclusion Criteria:

  1. students enrolled in any of the health-care related studies:

    • medical students
    • dental medicine students
    • pharmacy students
    • nursing students
    • physiotherapy students
    • dietetics/nutrition students
    • biomolecular science students
    • biomedical laboratory techniques students
    • psychology students
  2. economy students
  3. students of maritime sciences

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252924


Contacts
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Contact: Ivana Kolcic, Assoc. Prof. +385915762263 ikolcic@mefst.hr

Locations
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Croatia
Ivana Kolcic Recruiting
Split, Croatia, 21000
Contact: Ivana Kolcic, Assoc. Prof.    +385915762263    ikolcic@mefst.hr   
Sub-Investigator: Mario Marendic, PhD student         
Sub-Investigator: Nikolina Nika Vecek, PhD student         
Sub-Investigator: Ruzica Dragun, PhD student         
Italy
Department of Economics, University of Foggia Completed
Foggia, Italy, 71100
University of Pavia Recruiting
Pavia, Italy, 27100
Contact: Hellas Cena, Prof.    +39 0382 987542    hellas.cena@unipv.it   
Sub-Investigator: Rachele De Giuseppe, PhD         
Sub-Investigator: Debora Porri, PhD         
Sub-Investigator: Goezde Utan, MD         
Lebanon
Beirut Arab University Completed
Beirut, Lebanon, 11 5020
Poland
Institute of Psychology, University of Wroclaw; University of Social Sciences and Humanities (Katowice) Completed
Wroclaw, Poland, 50-527
Romania
Faculty of Veterinary Medicine, University of Agricultural Sciences and Veterinary Medicine Recruiting
Cluj-Napoca, Romania, 400372
Contact: Cristina Bianca Pocol, Prof    +40740176785    cristina.pocol@usamvcluj.ro   
Spain
Universidad Pablo De Olavide Recruiting
Sevilla, Spain, 41013
Contact: Donaldo Segundo Arteta Arteta, Prof    +34954977552    dsartart@upo.es   
Turkey
Koc University Completed
Istanbul, Turkey, 34450
Sponsors and Collaborators
University of Split, School of Medicine
University of Pavia
University of Foggia
Beirut Arab University
University of Wroclaw
University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca
Universidad Pablo de Olavide
Investigators
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Principal Investigator: Ivana Kolcic, Assoc. Prof. University of Split, School of Medicine
Publications:
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Responsible Party: Ivana Kolcic, Associate Professor, University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT04252924    
Other Study ID Numbers: USplitSM2
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Depends upon the agreement of all study sites investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivana Kolcic, University of Split, School of Medicine:
Mediterranean diet
physical activity
sleep
stress
orthorexia nervosa