An interventional study of Food education in Physical Inactivity, Eating Disorders and Eating Habit, sponsored by University of Pavia. Recruiting at 2 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by University of Pavia · Not applicable, Interventional, and Supportive care
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:
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).
740 studies on the registry are indexed under Feeding and Eating Disorders; 159 are open to participants now.
This study's planned enrollment of 23 is below the median of 75 across 540 interventional studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →University of Pavia is the lead sponsor of 141 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: Nutritional education
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).
Time frame: 6 months
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.
Time frame: 6 months
Weight
Standardised measurements: weight in kilograms
Time frame: 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.
Time frame: 6 months
Height
Standardised measurements: Height in centimeters (cm)
Time frame: 6 months
Skin folds
Skin folds (in millimeters) will be recorded by an expert dietician according to standardized procedures (Lohman, 1988).
Time frame: 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 (%).
Time frame: 6 months
Physical activity
Standardized tool used to assess an individual's physical activity levels and patterns. Higher scores mean a better outcome.
Time frame: 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).
Time frame: 6 months
Plan to share: No
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