Abstract
OBJECTIVES: In the last years, it has been proposed a new food classification system (named NOVA) based on the extent of food processing. The classification comes with the recommendation to limit or avoid the consumption of foods in the fourth category (Ultra-processed food (UPF) and drink products), given their potential implications on noncommunicable diseases. However, no definitive evidence has been provided about the association between UPF consumption and noncommunicable diseases. The present work presents the protocol of a study aimed at 1) assessing the impact of UPF consumption on obesity prevalence in Italian schoolchildren 2) evaluating the association between UPF consumption and noncommunicable diseases (cardiovascular diseases, diabetes, and cancer) in Italian children and adults. METHODS: A probability sampling design will be employed to select study participants representative of the Italian schoolchildren population with the purpose of deriving reliable estimates of childhood obesity prevalence in Italy. Study participants will undergo an anthropometric assessment and an interview aimed at assessing socio-demographic characteristics, health status, and lifestyle habits. The interview will include the administration of a food-frequency questionnaire (FFQ) and 24-hour dietary recall to assess the consumption of UPF. Each obese child (case) will be then matched to one normal-weight control based on socio-demographic variables. Families (both parents and siblings) of children involved in the case-control study will undergo a baseline assessment, including the assessment of the socio-economic status, health status, anthropometry, dietary and lifestyle habits. Children involved in the case-control study and their families will be then enrolled in a prospective cohort. Study cohort participants will undergo yearly follow-up of their health status using mobile technologies. RESULTS: The enrollment is expected to start in September 2020. The study has been already approved by the Ethical Committee. CONCLUSIONS: The study is expected to provide evidence on the relationship between UPF consumption and noncommunicable diseases in Italy. The present study will allow for the set-up of the first family prospective study cohort in Italy. FUNDING SOURCES: The study received an unrestricted grant from the Italian Ministry of Health.