MEditerranean LIfestyle in Pediatric Obesity Prevention
Last updated on July 2021Recruitment
- 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