Adapting Food Culture to the Mediterranean Pattern for International Students in Italy

Not Applicable

Recruiting

• Conditions: Eating Disorders; Eating Habit; Diet Habit; Physical Inactivity; Diet, Healthy
• Interventions: Behavioral: Food education

• Registration Number: NCT06474936
• Lead Sponsor: University of Pavia

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-05-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• ≥ 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mediterranean Diet Adhrence	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).

Secondary Outcome Measures

Name	Time	Method
Physical activity	6 months	Standardized tool used to assess an individual's physical activity levels and patterns. Higher scores mean a better outcome.
Weight	6 months	Standardised measurements: weight in kilograms
Dietary evaluation	6 months	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.
Height	6 months	Standardised measurements: Height in centimeters (cm)
Skin folds	6 months	Skin folds (in millimeters) will be recorded by an expert dietician according to standardized procedures (Lohman, 1988).
Fat mass	6 months	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).
Body Composition BIA	6 months	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 (%).
Short Form Health Survey	6 months	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.

Trial Locations

Locations (2)

Laboratory of Food Education and Sport Nutrition, Department of Public Health, Experimental and Forensic Medicine; 🇮🇹 Pavia, Italy

University of Pavia; 🇮🇹 Pavia, Italy