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

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.

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 Overview

• Status: Recruiting
• Conditions: Diet, Healthy; Diet Habit; Eating Disorders; Physical Inactivity; Eating Habit
• Intervention / Treatment: Behavioral: Food education

• Study Type: Interventional
• Enrollment (Estimated): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cinzia Ferraris, PhD; Phone Number: +39 0382.987868; Email: cinzia.ferraris@unipv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • University of Pavia
    • Contact: Cinzia Ferraris, PhD
  • Pavia, Italy, 27100
    • Recruiting
    • Laboratory of Food Education and Sport Nutrition, Department of Public Health, Experimental and Forensic Medicine
    • Contact: Cinzia Ferraris, PhD; Phone Number: +39 0382.987868; Email: cinzia.ferraris@unipv.it
    • Contact: Lenycia Neri, PhD; Phone Number: +39 0382.987842; Email: lenyciadecassya.lopesneri@unipv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Food habits education regarding the Mediterranean diet adapted according to the country of origin.

Behavioral: Food 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; Other Names: Nutritional education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
Weight	Standardised measurements: weight in kilograms	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.	6 months
Height	Standardised measurements: Height in centimeters (cm)	6 months
Skin folds	Skin folds (in millimeters) will be recorded by an expert dietician according to standardized procedures (Lohman, 1988).	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 (%).	6 months
Physical activity	Standardized tool used to assess an individual's physical activity levels and patterns. Higher scores mean a better outcome.	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).	6 months

Collaborators and Investigators

• Sponsor: University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 24013/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No