Abstract
BACKGROUND: Childhood obesity is a significant public health challenge, with Mediterranean countries showing high prevalence rates. While genetic factors play a role, diet and physical activity (PA) are critical modifiable influences. Emphasizing healthy dietary patterns, like the Mediterranean diet, and promoting regular PA can help mitigate obesity risk. METHODS: MELI-POP is a randomized controlled multi-center clinical trial in a cohort of children aged 3 to 6 years at baseline and being at obesity risk. The main objective consists on assessing the efficacy of an intervention during early childhood, considering a healthy lifestyle based on the promotion of a Mediterranean dietary pattern and regular PA, compared with a control group, on decreasing obesity incidence 5 and 10 years after the beginning of the intervention. It is expected to include 310 children, aged 3 to 6 years, having at baseline a normal weight or overweight according to the International Obesity Task Force (IOTF) criteria, and at least one parent having a body mass index > 25 kg/m(2). The clinical trial has two arms and is performed in Spanish Primary Health Care centers. The control group receive usual care by healthcare professionals. The intervention group receive education on Mediterranean diet and PA, combined with the provision of extra-virgin olive oil and fish, in order to be consumed at least 2 times per week. Free PA sessions with a physical education teacher are also offered for the children (3 sessions of 60 min of moderate-vigorous PA per week). The participants' adherence to the intervention is periodically monitored. The study primarily focuses on adiposity as the main outcome, with secondary outcomes encompassing dietary intake and eating habits, physical activity and lifestyle behaviors (including extracurricular sports, screen time, and sleep duration), physical fitness, biochemical parameters (such as inflammation and cardiometabolic biomarkers, fatty acids, and oxidation), as well as microbiota, genetic, omic and metabolomic analyses. DISCUSSION: Beneficial results are expected by preventing obesity during childhood, and associated comorbidities. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT04597281.