Viewing Study NCT04597281



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Last Modification Date: 2024-10-26 @ 1:47 PM
Study NCT ID: NCT04597281
Status: RECRUITING
Last Update Posted: 2020-10-22
First Post: 2020-09-28

Brief Title: MEditerranean LIfestyle in Pediatric Obesity Prevention
Sponsor: Luis A Moreno Aznar
Organization: Universidad de Zaragoza

Study Overview

Official Title: MEditerranean LIfestyle in Pediatric Obesity Prevention
Status: RECRUITING
Status Verified Date: 2020-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MELI-POP
Brief Summary: The current project is a randomized controlled multi-centre 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 physical activity compared with a control group on decreasing obesity incidence 5 and 10 years after the beginning of the intervention It is envisaged to include 738 children aged 3 to 6 years having at baseline a body mass index BMI than the equivalent to 30 kgm2 in adults and at least one parent having a BMI 25 kgm2 The clinical trial will have two arms and will be performed in Primary Health centres in 3 cities Córdoba Santiago de Compostela and Zaragoza The control group will receive usual care by healthcare professionals The intervention group will receive education on Mediterranean lifestyle Mediterranean diet and physical activity promotion combined with the provision of extra-virgin olive oil and fish in order to be consumed at least 3 times per week Physical activity sessions with a physical activity monitor will also be offered for free to the children 2 sessions of 60 minutes of moderate-vigorous physical activity per week The participants degree of compliance with the intervention will be periodically monitored The main outcome is the incidence of obesity and the secondary outcomes are changes in body composition physical fitness and cardiovascular risk factors We are targeting for a 10 year follow-up
Detailed 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 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

1 To decrease obesity incidence 5 and 10 years after the start of the intervention Secondary objectives
2 To improve body composition Body mass index z-score Fat mass index z-score waist circumference assessed in a yearly basis
3 To improve health-related physical fitness assessed in a yearly basis
4 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
5 To increase the adherence to a Mediterranean dietary pattern 1 3 5 and 10 years after the start of the intervention
6 To increase the adherence to age-specific physical activity recommendations 1 3 5 and 10 years after the start of the intervention

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None