Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Obesity, Childhood
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 3 years and 7 years
Gender
Both males and females

Description

Hypothesis A healthy lifestyle, based on the promotion of the Mediterranean dietary pattern and regular physical activity, decrease the likelihood of developing obesity and cardio-metabolic abnormalities during childhood and adolescence. Objectives To assess, in a cohort of children at high risk of ...

Hypothesis A healthy lifestyle, based on the promotion of the Mediterranean dietary pattern and regular physical activity, decrease the likelihood of developing obesity and cardio-metabolic abnormalities during childhood and adolescence. Objectives To assess, in a cohort of children at high risk of obesity, if an intervention during childhood and adolescence, considering a healthy lifestyle based on the promotion of Mediterranean dietary pattern and regular physical activity, when compared with a control group Main objective To decrease obesity incidence 5 and 10 years after the start of the intervention Secondary objectives To improve body composition (Body mass index z-score, Fat mass index z-score, waist circumference) assessed in a yearly basis To improve health-related physical fitness assessed in a yearly basis To improve cardiovascular risk factor (classic and omics) associated with obesity 1, 3, 5 and 10 years after the start of the intervention Intermediary objectives To increase the adherence to a Mediterranean dietary pattern 1, 3, 5 and 10 years after the start of the intervention To increase the adherence to age-specific physical activity recommendations 1, 3, 5 and 10 years after the start of the intervention

Tracking Information

NCT #
NCT04597281
Collaborators
  • Instituto Maimónides de Investigación Biomédica de Córdoba
  • Fundación del Instituto de Investigación Sanitaria de Santiago
Investigators
Principal Investigator: Luis A Moreno Aznar, MD, PhD Universidad de Zaragoza