NCT04252924

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
7 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

January 30, 2020

Last Update Submit

January 31, 2020

Conditions

Keywords

Mediterranean dietphysical activitysleepstressorthorexia nervosa

Outcome Measures

Primary Outcomes (4)

  • 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.

    1 day

  • 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

    1 day

  • sleep duration

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

    1 day

  • 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.

    1 day

Secondary Outcomes (2)

  • Orthorexia nervosa

    1 day

  • Orthorexia nervosa

    1 day

Study Arms (1)

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

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

students

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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
  • economy students
  • students of maritime sciences

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ivana Kolcic

Split, 21000, Croatia

RECRUITING

Department of Economics, University of Foggia

Foggia, 71100, Italy

COMPLETED

University of Pavia

Pavia, 27100, Italy

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

Seville, 41013, Spain

RECRUITING

Koc University

Istanbul, 34450, Turkey (Türkiye)

COMPLETED

Related Publications (5)

  • 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.

    PMID: 26035442BACKGROUND
  • 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.

    PMID: 12900694BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 16682853BACKGROUND

MeSH Terms

Conditions

HabitsHealth BehaviorFeeding BehaviorMotor ActivityOrthorexia Nervosa

Condition Hierarchy (Ancestors)

BehaviorBehavior, AnimalFeeding and Eating DisordersMental Disorders

Study Officials

  • Ivana Kolcic, Assoc. Prof.

    University of Split, School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivana Kolcic, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

April 20, 2018

Primary Completion

April 20, 2021

Study Completion

April 20, 2021

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations