PREVENT TOGETHER - PRospEctive randomized parallel controlled, open-label, multicentre trial of interVENTional sTrategies prOmotinG hEalTHy diEt and physical activity among childRen and their families


Resp. Scientifico: Prof. Marco Metra, [email protected]

Professore Ordinario di Malattie dell'apparato cardiovascolare


Finanziato da: Fondazione Cariplo nell’ambito del Bando “Cibo e salute 2022”


Inizio progetto: 1° settembre 2022 – Data fine progetto 1° settembre 2024

Capofila: Università Degli Studi Di Brescia (UNIBS)

Partner: Scuola Superiore di Studi Avanzati - SSAS – Sapienza Università di Roma (Sapienza School for Advanced Studies)



The prevalence of childhood obesity has been increasing in the last years, representing one of the most significant paediatric challenges. Exposure to risk factors in early life has been associated with adult preclinical cardiovascular (CVD) (Raitakari O et al., 2022; Srinivasan SR et al., 1996). Namely, childhood obesity is associated with an increased risk of adulthood obesity, arterial hypertension, dyslipidaemia and exposes young people to severe complications, such as non[1]alcoholic fatty liver disease, type 2 diabetes mellitus, atherosclerosis and alterations of the cardiovascular system. Importantly, these long-term effects are substantially reduced if the individual becomes free from the risk factor by adulthood (Raitakari O et al., 2022). Interventions aimed at promoting healthy habits in children had proven efficacy in producing sustained reduction of these risk factors (Peñalvo et al., 2015; Dobbins et al. 2013; Fernandez-Jimenez, 2019) Schools and families are privileged places for health promotion and delivery of scientifically validated lifestyle interventions (Gorga et al., 2016). However, a major effort is needed in order to improve preventive strategies. A PRospEctive randomized parallel controlled, open-label, multicentre trial of interVENTional sTrategies prOmotinG hEalTHy diEt and physical activity among childRen and their families (PREVENT TOGETHER) is a prospective randomized parallel controlled, open-label, multicentre study trial, enrolling children aged 11-14. PREVENT TOGETHER will investigate the role of educational and active interventions on lifestyle and eating habits of an educational intervention programme in children aged 11-14 years. The programme will focus on a multidisciplinary approach. Participants (schools) will be randomly assigned in a 1:1 ratio to either intervention with the PREVENT TOGETHER Program or the usual curriculum. Participating schools will be selected in Lombardy and Lazio (Italy), in different urban environments (metropolitan area, middle size town and marginal areas). Approximately 50 Italian classes will be involved. Target children will be aged between 11-14 years. The entire study period will last one year. The major objectives of the present study are 1) to investigate factors related to different prevalence of childhood obesity in different regions of Italy (Lombardy, as an example of “virtuous” region, and Lazio, burdened with a higher incidence of obesity) 2) to evaluate the impact on both anthropometric measurements and attitudes of a multidisciplinary intervention aimed at improving dietary habits and promote physical activity among secondary school children. The impact of this intervention will be evaluated in both regions in Italy, possibly highlighting crucial geographic differences. We will evaluate as primary endpoint a change in mean body mass index (BMI) from baseline to 12 months (at the end of the intervention period) and identify the correlation between the index, the living and the food environment, as well as urban planning decisions. Secondary endpoints will include other biometric parameters and adiposity indexes, i.e. body weight, height, waist/hip ratio, waist circumference, and skinfold thickness (triceps and subscapular) standardized to z-scores according to Centre for Disease Control (CDC) and World Health Organization (WHO); assessment of the knowledge(K), attitude (A), and habits (H) KAH-questionnaire; assessment of physical activity with a questionnaire. A baseline and 15-months (end of study) questionnaire will be also administered to evaluate changes in habits and lifestyle in the recruited children and their families.

Costo totale del progetto: Euro 250.000,00

Contributo Cariplo ricevuto da UNIBS: Euro 142.000,00