HabitsHOLISTicNCT04252924
Habits, Orthorexia Nervosa and LIfestyle in STudents
An observational study of Habits and Health Behavior, run by University of Split, School of Medicine at 8 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Habits, Health Behavior, Diet Habit
- What is being tested?
- lifestyle characteristics
- How many people
- 5,000 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 20 Apr 2018to 20 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- students enrolled in any of the health-care related studies:
- medical students
- dental medicine students
- pharmacy students
- nursing students
- physiotherapy students
Show all 12Show fewer
- dietetics/nutrition students
- biomolecular science students
- biomedical laboratory techniques students
- psychology students
- economy students
- students of maritime sciences
Who cannot join
- none
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Italy2 sites, 1 recruiting
- Completed
Department of Economics, University of Foggia
Foggia, 71100
- Recruiting
University of Pavia
Pavia, 27100
Hellas Cena, Prof., +39 0382 987542, hellas.cena@unipv.it
Rachele De Giuseppe, PhD
Croatia1 site, 1 recruiting
- Recruiting
Ivana Kolcic
Split, 21000
Ivana Kolcic, Assoc. Prof., +385915762263, ikolcic@mefst.hr
Mario Marendic, PhD student
Poland1 site
- Completed
Institute of Psychology, University of Wroclaw; University of Social Sciences and Humanities (Katowice)
Wroclaw, 50-527
Romania1 site, 1 recruiting
- Recruiting
Faculty of Veterinary Medicine, University of Agricultural Sciences and Veterinary Medicine
Cluj-Napoca, 400372
Cristina Bianca Pocol, Prof, +40740176785, cristina.pocol@usamvcluj.ro
Spain1 site, 1 recruiting
- Recruiting
Universidad Pablo De Olavide
Seville, 41013
Donaldo Segundo Arteta Arteta, Prof, +34954977552, dsartart@upo.es
About this study
Official title: The Prevalence of Healthy Lifestyle in Students in Europe: the Mediterranean Diet, Orthorexia Nervosa, Appropriate Physical Activity, Stress Perception, and Sleep Habits
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.
- Conditions
- Habits, Health Behavior, Diet Habit, Sleep, Stress, Physical Activity
- Being tested
- lifestyle characteristics
- Keywords
- Mediterranean diet, physical activity, sleep, stress, orthorexia nervosa
- Medical subject headings
- Habits, Health Behavior, Feeding Behavior, Motor Activity, Orthorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle characteristicsOther
Exposures of interest: Mediterranean diet, orthorexia nervosa, smoking, physical activity, sleep duration, stress level
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: lifestyle characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 day
sleep duration
Based on self-reported data using a questionnaire (time of going to sleep and waking up)
Measured: 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.
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 Apr 2018
- Primary completion20 Apr 2021 (estimated)
- Study completion20 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Ivana Kolcic, University of Split, School of Medicine
- Investigators
- Ivana Kolcic, Assoc. Prof., Principal investigator, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252924
- Sponsor's protocol ID
- USplitSM2
- Acronym
- HOLISTic
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends upon the agreement of all study sites investigators
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 26035442Craig 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 12900694Cohen 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 6668417Gleaves 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Healthy Lifestyle in Students in Europe: the Mediterranean Diet, Orthorexia Nervosa, Appropriate Physical Activity, Stress Perception, and Sleep Habits
- ClinicalTrials.gov ID
- NCT04252924
- Acronym / sponsor ID
- HOLISTic / USplitSM2
- Conditions
- Habits, Health Behavior, Diet Habit, Sleep, Stress, Physical Activity
- Keywords
- Mediterranean diet, physical activity, sleep, stress, orthorexia nervosa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- 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
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 20 Apr 2021 (estimated)
- Study completion
- 20 Apr 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| students | – | Other: lifestyle characteristicsmedical 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (12 listed)
- students enrolled in any of the health-care related studies:
- economy students
- students of maritime sciences
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle characteristicsExposures of interest: Mediterranean diet, orthorexia nervosa, smoking, physical activity, sleep duration, stress level | Other | students |
Primary outcome
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.
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
sleep duration
Time frame: 1 day
Based on self-reported data using a questionnaire (time of going to sleep and waking up)
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.
2 secondary outcomes
Orthorexia nervosa
Time frame: 1 day
Orthorexia nervosa
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 26035442Monteagudo 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.
- Background: PubMed 12900694Craig 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundGleaves 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: PubMed 16682853Donini 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.
- Individual participant dataSharing planned: Undecided. Depends upon the agreement of all study sites investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivana Kolcic, Assoc. Prof. principal investigator
University of Split, School of Medicine
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Habits and Health Behavior, run by University of Split, School of Medicine at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Croatia, Lebanon, Poland, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivana Kolcic, Assoc. Prof. (+385915762263, ikolcic@mefst.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Mediterranean diet adherence (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252924, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.