GOOD-DAY: Efficacy of Gamification of an educatiOnal Training tO meDiterranean Diet on Weight and Metabolic Control in pAediatric obesitY: a Pilot Open-label Randomized Controlled Trial

Study design: A single-center pilot open-label randomized control trial. Population: The study will comprise a total of 60 subjects of both sexes, between 10 and 18 years of age, obese, according to the IOTF criteria (Cole TJ et al., 2000) and with visceral adiposity, as waist circumference ≥ 90th percentile (Cook S et al., 2003 - Cruz ML, Goran MI, 2004 - de Ferranti SD et al., 2004), diet naïve or with failure of weight loss (defined as -1 kg/m2 BMI in 1 year).

Inclusion/ Exclusion criteria (see Eligibility Criteria). Intervention: Patients will be randomized in a open-label, into two groups homogeneous for number and sex of the subjects. One group (group SD) will receive Standard Diet according to routine care and practice, and one group (group SD+MSD) will receive a standard diet according to routine clinical practice + a 30 minutes Mediterranean-Style Diet educational training with explanation of Mediterranean pyramid + gamification to Mediterranean diet inside the Hospital and at home throughout "The Mediterranean Goose".

Dietary restriction: Thestandard diet will be distributed with 55-60% of carbohydrates (45-50% complex and no more than 10% refined and processed sugars), 25-30% lipids and 15% proteins, and will be performedin accordance with the calories of an isocaloric balanced diet calculated throughout the Italian LARN Guidelines for age and gender (Società Italiana di Nutrizione Umana, 2014), inspired to Mediterranean pyramid.The standard diet will be given as diet plans in writing, after explanation by a well-trained and experienced clinical paediatric endocrinologist.

Education in Hospital: As well as receiving the aforementioned recommendations, the SD+MSD group will also receive a simple visual guide of Mediterranean food pyramid explained by a dietitian/nutritionist for 30 minutes (Bach-Faig A et al., 2011).

Gamification: The MSD Group will be involved inside the Hospital in an educational and playful training playing to "The Mediterranean Goose" in the ludic area of the Pediatric Department; this game has been proposed in an educational project known as "Mediterranean diet and enhancement of traditional foodstuff - MedDiet", founded by European Union in the framework of the ENPI CBC Mediterranean Sea Basin Programme (www.med-diet.eu). This material will be given to the family for continue to play also at home.