Promoting a Mediterranean lifestyle to prevent obesity in young children
Official title: MEditerranean LIfestyle in Pediatric Obesity Prevention
Run by Universidad de Zaragoza · NCT04597281 · Data updated 2026-11-12
This study is testing if teaching young children a Mediterranean diet and encouraging them to be active can help prevent obesity and improve their health over several years.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 7 Years |
| Sex | All |
| Enrollment | 738 (estimated) |
| Sponsor | Universidad de Zaragoza Academic / other |
| Locations | 3 sites (Córdoba and 2 other locations) |
| Status | Recruiting |
| Started | March 1, 2018 |
| Main results expected | June 30, 2022 |
| Study ends | December 31, 2032 |
| Registry record updated | October 22, 2020 |
| Trial ID | NCT04597281 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 6 years with at least one parent having a BMI of 25 or higher.
✕Probably not a fit
Patients who may not benefit include those under 3 or over 7 years old, or from families unable to adhere to the dietary intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a randomized controlled multi-centre intervention aimed at children aged 3 to 6 years who are at risk of obesity. It evaluates the effectiveness of a lifestyle intervention that promotes a Mediterranean dietary pattern and regular physical activity compared to a control group receiving standard care. The study will assess the incidence of obesity and related health outcomes over a period of 5 to 10 years, involving 738 children and their families across three cities in Spain. The intervention's impact on body composition, physical fitness, and cardiovascular risk factors will also be monitored annually.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of obesity and improve overall health in children at risk.
How similar studies have gone: Other studies have shown promising results with lifestyle interventions focused on dietary patterns and physical activity in preventing obesity, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Instituto Maimónides de Investigación Biomédica de Córdoba
Córdoba, Spain Recruiting -
Fundación del Instituto de Investigación Sanitaria de Santiago
Santiago de Compostela, Spain Recruiting -
Instituto de Investigación Sanitaria Aragón
Zaragoza, Spain Recruiting
Study contacts
- Principal investigator: Luis A Moreno Aznar, MD, PhD — Universidad de Zaragoza
- Study coordinator: Luis A Moreno Aznar, MD, PhD
- Email: lmoreno@unizar.es
- Phone: +34976761000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.