Physical InactivityMeditEatNCT06474936
Adapting Food Culture to the Mediterranean Pattern for International Students in Italy
A study testing Food education in people with Physical Inactivity and Eating Disorders, run by University of Pavia at 2 sites in Italy.
Trial summary
The goal of this clinical trial is to describe the adherence to the Mediterranean diet, the nutritional status, the level of physical activity, and possible eating disorders in international students attending the University of Pavia before and after a food education intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Eating Disorders, Eating Habit
- What is being tested?
- Food education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesItaly
- Study dates
- 1 May 2024to 1 Nov 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Able to understand English or Italian
- Nationality diverse than Italian
- Absence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc.
Who cannot join
- ≤18 years old;
- Italian nationality;
- Presence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Laboratory of Food Education and Sport Nutrition, Department of Public Health, Experimental and Forensic Medicine
Pavia, 27100
Cinzia Ferraris, PhD, +39 0382.987868, cinzia.ferraris@unipv.it
Lenycia Neri, PhD, +39 0382.987842, lenyciadecassya.lopesneri@unipv.it
- Recruiting
University of Pavia
Pavia, 27100
Cinzia Ferraris, PhD
About this study
Official title: Nutritional Health Assistance for Adapting Food Culture to the Mediterranean Pattern for International Students at the University of Pavia (MeditEat)
The goal of this clinical trial is to describe the adherence to the Mediterranean diet, the nutritional status, the level of physical activity, and possible eating disorders in international students attending the University of Pavia before and after a food education intervention. The main questions it aims to answer are:
Does the intervention of food education change the nutritional status of the international students of the University of Pavia? Does the intervention of food education change the level of physical activity of international students of the University of Pavia? Does the intervention of food education change the possible risk of eating disorders related to the possible change of diet from the country of origin of international students? Researchers will compare the measurements done at the first meeting to the measurements made at the last meeting (6 months) to see if the food educational intervention helped the students.
Read more
Participants will:
- have the body composition analysed by anthropometric measurements (weight, height, electric bio impedance)
- Receive personalized guidance and support from our team of experts for 6 months.
Visit the clinic 3 times (beginning, 3 months, and by the end of 6 months) for check-ups and tests, and participate in online meetings the other 3 months (second, fourth, and fifth).
Answer online questionnaires and perform a 3-day food diary (beginning, 3 months, and by the end of 6 months).
- Conditions
- Physical Inactivity, Eating Disorders, Eating Habit, Diet, Healthy, Diet Habit
- Being tested
- Food education
- Medical subject headings
- Sedentary Behavior, Feeding and Eating Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food educationBehavioural
Also called Nutritional education
During the consultations are planned at least 6 nutritional education sessions in which the general nutritional advice provided by the Mediterranean Diet will be exposed, and some paper materials can be delivered according to the needs of each individual. 3 in-person meetings and 3 online meetings are planned. Both online and in-person food education sessions will be conducted by experienced nutrition experts monthly. These sessions will cover a range of topics, including the principles of the Mediterranean diet, practical cooking skills, meal-planning strategies, and tips for incorporating Mediterranean-style dishes into daily life
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Food habits education regarding the Mediterranean diet adapted according to the country of origin. Receives: Behavioral: Food education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mediterranean Diet Adhrence
Mediterranean Diet Score9 (MEDI-LITE): a tool for measuring adherence to the Mediterranean diet. It assigns points based on the frequency of consumption of nine food categories: (1) fruit; (2) vegetables; (3) cereal grains; (4) legumes; (5) fish and fish products; (6) meat and meat products; (7) dairy products; (8) alcohol intake and (9) olive oil. The final score was obtained by summing these values, and it varies from 0 (low adherence) to 18 (high adherence).
Measured: 6 months
Secondary outcomes (8)
Short Form Health Survey
The SF-36, short for the 36-Item Short Form Health Survey, is a widely used and well-established tool in the field of health-related quality of life assessment. Higher scores mean a better outcome.
Measured: 6 months
Weight
Standardised measurements: weight in kilograms
Measured: 6 months
Dietary evaluation
Food diaries: will be requested for all participants a 3-day food diary by baseline, 3 and 6 months. These diaries will be calculated by macro and micronutrient intake. Food frequency questionnaire 110 items will be applied at T0, T3 and T6. The presence of typical Mediterranean food will be considered as a marker of acculturation.
Measured: 6 months
Height
Standardised measurements: Height in centimeters (cm)
Measured: 6 months
Skin folds
Skin folds (in millimeters) will be recorded by an expert dietician according to standardized procedures (Lohman, 1988).
Measured: 6 months
Body Composition BIA
The Bioelectrical Impedance Analysis, which is a non-invasive and commonly used method for assessing body composition (BIA 101 BIVA PROTM- AKERN) in terms of percentage of fat mass (%).
Measured: 6 months
Physical activity
Standardized tool used to assess an individual's physical activity levels and patterns. Higher scores mean a better outcome.
Measured: 6 months
Fat mass
The evaluation of body composition will be carried out on the basis of skinfold measurements, and using the Bioelectrical Impedance Analysi. The median from the 2 measurements (skinfold and BIA) for fat mass will be used (in percentage).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 May 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474936
- Sponsor's protocol ID
- 24013/2024
- Acronym
- MeditEat
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neri LCL, Fiorini S, Bosio F, Guglielmetti M, Ferraro OE, Tagliabue A, Ferraris C. Nutritional health assistance for adapting food culture to the Mediterranean pattern for international students: study protocol. Int J Food Sci Nutr. 2025 Nov;76(7):725-735. doi: 10.1080/09637486.2025.2561711. Epub 2025 Sep 25.
PubMed 40995823
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Health Assistance for Adapting Food Culture to the Mediterranean Pattern for International Students at the University of Pavia (MeditEat)
- ClinicalTrials.gov ID
- NCT06474936
- Acronym / sponsor ID
- MeditEat / 24013/2024
- Conditions
- Physical Inactivity, Eating Disorders, Eating Habit, Diet, Healthy, Diet Habit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 26 Jun 2024 (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.
The goal of this clinical trial is to describe the adherence to the Mediterranean diet, the nutritional status, the level of physical activity, and possible eating disorders in international students attending the University of Pavia before and after a food education intervention. The main questions it aims to answer are:
Does the intervention of food education change the nutritional status of the international students of the University of Pavia? Does the intervention of food education change the level of physical activity of international students of the University of Pavia? Does the intervention of food education change the possible risk of eating disorders related to the possible change of diet from the country of origin of international students? Researchers will compare the measurements done at the first meeting to the measurements made at the last meeting (6 months) to see if the food educational intervention helped the students.
Participants will:
- have the body composition analysed by anthropometric measurements (weight, height, electric bio impedance)
- Receive personalized guidance and support from our team of experts for 6 months.
Visit the clinic 3 times (beginning, 3 months, and by the end of 6 months) for check-ups and tests, and participate in online meetings the other 3 months (second, fourth, and fifth).
Answer online questionnaires and perform a 3-day food diary (beginning, 3 months, and by the end of 6 months).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Food educationFood habits education regarding the Mediterranean diet adapted according to the country of origin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years old
- Able to understand English or Italian
- Nationality diverse than Italian
- Absence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc.
Key exclusion criteria (3 listed)
- ≤18 years old;
- Italian nationality;
- Presence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc.
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 |
|---|---|---|
| Food educationAlso: Nutritional educationDuring the consultations are planned at least 6 nutritional education sessions in which the general nutritional advice provided by the Mediterranean Diet will be exposed, and some paper materials can be delivered according to the needs of each individual. 3 in-person meetings and 3 online meetings are planned. Both online and in-person food education sessions will be conducted by experienced nutrition experts monthly. These sessions will cover a range of topics, including the principles of the Mediterranean diet, practical cooking skills, meal-planning strategies, and tips for incorporating Mediterranean-style dishes into daily life | Behavioural | Intervention |
Primary outcome
Mediterranean Diet Adhrence
Time frame: 6 months
Mediterranean Diet Score9 (MEDI-LITE): a tool for measuring adherence to the Mediterranean diet. It assigns points based on the frequency of consumption of nine food categories: (1) fruit; (2) vegetables; (3) cereal grains; (4) legumes; (5) fish and fish products; (6) meat and meat products; (7) dairy products; (8) alcohol intake and (9) olive oil. The final score was obtained by summing these values, and it varies from 0 (low adherence) to 18 (high adherence).
8 secondary outcomes
Short Form Health Survey
Time frame: 6 months
Weight
Time frame: 6 months
Dietary evaluation
Time frame: 6 months
Height
Time frame: 6 months
Skin folds
Time frame: 6 months
Body Composition BIA
Time frame: 6 months
Physical activity
Time frame: 6 months
Fat mass
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 40995823Neri LCL, Fiorini S, Bosio F, Guglielmetti M, Ferraro OE, Tagliabue A, Ferraris C. Nutritional health assistance for adapting food culture to the Mediterranean pattern for international students: study protocol. Int J Food Sci Nutr. 2025 Nov;76(7):725-735. doi: 10.1080/09637486.2025.2561711. Epub 2025 Sep 25.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food education in people with Physical Inactivity and Eating Disorders, run by University of Pavia at 2 sites in Italy.
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 4 inclusion and 3 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 Cinzia Ferraris, PhD (+39 0382.987868, cinzia.ferraris@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mediterranean Diet Adhrence (time frame: 6 months). 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 NCT06474936, which also lists 1 linked publication.
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 26 Jun 2024.