Habits, Orthorexia Nervosa and LIfestyle in STudents

Physical Activity Clinical Trial

— HOLISTic  

Official title:

The Prevalence of Healthy Lifestyle in Students in Europe: the Mediterranean Diet, Orthorexia Nervosa, Appropriate Physical Activity, Stress Perception, and Sleep Habits

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04252924
• Other study ID #: USplitSM2
• Status: Recruiting
• Start date: April 20, 2018
• Est. completion date: April 20, 2021

Study information

• Verified date: January 2020
• Source: University of Split, School of Medicine
• Contact: Ivana Kolcic, Assoc. Prof.
• Phone: +385915762263
• Email: ikolcic[@]mefst.hr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: April 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Croatia	Ivana Kolcic	Split
Italy	Department of Economics, University of Foggia	Foggia
Italy	University of Pavia	Pavia
Lebanon	Beirut Arab University	Beirut
Poland	Institute of Psychology, University of Wroclaw; University of Social Sciences and Humanities (Katowice)	Wroclaw
Romania	Faculty of Veterinary Medicine, University of Agricultural Sciences and Veterinary Medicine	Cluj-Napoca
Spain	Universidad Pablo De Olavide	Sevilla
Turkey	Koc University	Istanbul

Sponsors (7)

Lead Sponsor	Collaborator
University of Split, School of Medicine	Beirut Arab University, Universidad Pablo de Olavide, University of Agricultural Sciences and Veterinary Medicine Cluj-Napoca, University of Foggia, University of Pavia, University of Wroclaw

Countries where clinical trial is conducted

Croatia,  Italy,  Lebanon,  Poland,  Romania,  Spain,  Turkey, 

References & Publications (5)

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

Craig CL, Marshall AL, Sjöström 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. — View Citation

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. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	sleep duration	Based on self-reported data using a questionnaire (time of going to sleep and waking up)	1 day
Primary	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	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.	1 day
Secondary	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.	1 day