CClinicalTrials.gg
Status unknownNCT04252924HOLISTicUpdated Feb 5, 2020

Habits, Orthorexia Nervosa and LIfestyle in STudents

An observational study in Habits, Health Behavior and Diet Habit, sponsored by University of Split, School of Medicine. Status unknown at 8 sites in 7 countries. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by University of Split, School of Medicine · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
5,000
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Habits
  • Health Behavior
  • Diet Habit
  • Sleep
  • Stress
  • Physical Activity

Keywords

  • Mediterranean diet
  • physical activity
  • sleep
  • stress
  • orthorexia nervosa
03

In context

Lead sponsor

University of Split, School of Medicine is the lead sponsor of 49 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
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)

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

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
5,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Otherlifestyle characteristics

    Exposures of interest: Mediterranean diet, orthorexia nervosa, smoking, physical activity, sleep duration, stress level

06

What researchers measure

Primary outcomes

  1. the Mediterranean diet adherence

    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.

    Time frame: 1 day

  2. moderate to vigorous level of physical activity

    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

    Time frame: 1 day

  3. sleep duration

    Based on self-reported data using a questionnaire (time of going to sleep and waking up)

    Time frame: 1 day

  4. stress level

    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.

    Time frame: 1 day

Secondary outcomes

  1. Orthorexia nervosa

    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.

    Time frame: 1 day

  2. Orthorexia nervosa

    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.

    Time frame: 1 day

07

Study locations

4 of 8 sites recruiting
  • Ivana Kolcic
    Split, 21000, Croatia
    • Ivana Kolcic, Assoc. Prof. · Contact · ikolcic@mefst.hr · +385915762263
    • Mario Marendic, PhD student · Sub investigator
    • Nikolina Nika Vecek, PhD student · Sub investigator
    • Ruzica Dragun, PhD student · Sub investigator
    Recruiting
  • Department of Economics, University of Foggia
    Foggia, 71100, Italy
    Completed
  • University of Pavia
    Pavia, 27100, Italy
    • Hellas Cena, Prof. · Contact · hellas.cena@unipv.it · +39 0382 987542
    • Rachele De Giuseppe, PhD · Sub investigator
    • Debora Porri, PhD · Sub investigator
    • Goezde Utan, MD · Sub investigator
    Recruiting
  • Beirut Arab University
    Beirut, 11 5020, Lebanon
    Completed
  • Institute of Psychology, University of Wroclaw; University of Social Sciences and Humanities (Katowice)
    Wroclaw, 50-527, Poland
    Completed
  • Faculty of Veterinary Medicine, University of Agricultural Sciences and Veterinary Medicine
    Cluj-Napoca, 400372, Romania
    Recruiting
  • Universidad Pablo De Olavide
    Sevilla, 41013, Spain
    • Donaldo Segundo Arteta Arteta, Prof · Contact · dsartart@upo.es · +34954977552
    Recruiting
  • Koc University
    Istanbul, 34450, Turkey
    Completed
08

References and documents

Publications

  • Monteagudo C, Mariscal-Arcas M, Rivas A, Lorenzo-Tovar ML, Tur JA, Olea-Serrano F. Proposal of a Mediterranean Diet Serving Score. PLoS One. 2015 Jun 2;10(6):e0128594. doi: 10.1371/journal.pone.0128594. eCollection 2015. PubMed 26035442 ↗
  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB. PubMed 12900694 ↗
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. PubMed 6668417 ↗
  • Gleaves DH, Graham EC, Ambwani S. Measuring 'Orthorexia': Development of the Eating Habits Questionnaire. International Journal of Educational and Psychological Assessment. 12(2):1-18, 2013.
  • Donini LM, Marsili D, Graziani MP, Imbriale M, Cannella C. Orthorexia nervosa: validation of a diagnosis questionnaire. Eat Weight Disord. 2005 Jun;10(2):e28-32. doi: 10.1007/BF03327537. PubMed 16682853 ↗

Individual participant data

Plan to share: Undecided — Depends upon the agreement of all study sites investigators

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04252924
Lead sponsor
University of Split, School of Medicine
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
Responsible party
Ivana Kolcic (Associate Professor, University of Split, School of Medicine) — Principal investigator
First posted
Feb 5, 2020
Start date
Apr 20, 2018
Primary completion
Apr 20, 2021 (estimated)
Completion
Apr 20, 2021 (estimated)
Last update
Feb 5, 2020

Study contacts

Ivana Kolcic, Assoc. Prof.
Contact
ikolcic@mefst.hr
+385915762263
Ivana Kolcic, Assoc. Prof.
principal investigator · University of Split, School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion