NCT06474936

Brief 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. 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).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 13, 2024

Last Update Submit

June 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months

Secondary Outcomes (8)

  • Short Form Health Survey

    6 months

  • Weight

    6 months

  • Dietary evaluation

    6 months

  • Height

    6 months

  • Skin folds

    6 months

  • +3 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Food habits education regarding the Mediterranean diet adapted according to the country of origin.

Behavioral: Food education

Interventions

Food educationBEHAVIORAL

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

Also known as: Nutritional education
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • ≤18 years old;
  • Italian nationality;
  • Presence of major morbidities that interfere with food choices, such as diabetes, hypertension, renal dysfunction, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laboratory of Food Education and Sport Nutrition, Department of Public Health, Experimental and Forensic Medicine

Pavia, 27100, Italy

RECRUITING

University of Pavia

Pavia, 27100, Italy

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sedentary BehaviorFeeding and Eating DisordersFeeding Behavior

Condition Hierarchy (Ancestors)

BehaviorSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior, Animal

Central Study Contacts

Cinzia Ferraris, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 26, 2024

Study Start

May 1, 2024

Primary Completion

May 1, 2025

Study Completion

November 1, 2025

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations