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MEditerranean LIfestyle in Pediatric Obesity Prevention

RecruitingNAAges 3 Years - 7 YearsAllLuis A. Moreno Aznar
NCT04597281 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 kg/m2 in adults, and at least one parent having a BMI \> 25 kg/m2. 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 profes

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📋 Eligibility rules (as published)
Inclusion Criteria: * Children \> 3 years and \< 7 years, with at least one parent having a BMI ≥ 25 kg/m2, with no disease responsible for the high BMI. * Children with normal- or over weight, following the IOTF criteria (Cole TJ, Lobstein T. Pediatr Obes 2012; 7: 284-294). Exclusion Criteria: * Children \< 3, or \> 7 yearss, or both parents Having BMI \<25 kg/m2. * Children with chornic diseases or following a therapeutic diet . * Children from families having dietary habits not fitting with the characteristics of the dietary intervention. * Children from families having difficulties to follow the protocol.
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What it tests

  • Lifestyle intervention
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Where

3 sites
Instituto Maimónides de Investigación Biomédica de Córdoba
Córdoba, Spain
Fundación del Instituto de Investigación Sanitaria de Santiago
Santiago de Compostela, Spain
Instituto de Investigación Sanitaria Aragón
Zaragoza, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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