NCT04597281 MEditerranean LIfestyle in Pediatric Obesity Prevention
| NCT ID | NCT04597281 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Luis A. Moreno Aznar |
| Condition | Obesity, Childhood |
| Study Type | INTERVENTIONAL |
| Enrollment | 738 participants |
| Start Date | 2018-03-01 |
| Primary Completion | 2022-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 738 participants in total. It began in 2018-03-01 with a primary completion date of 2022-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Eligibility 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.
Contact & Investigator
Luis A Moreno Aznar, MD, PhD
PRINCIPAL INVESTIGATOR
Universidad de Zaragoza
Frequently Asked Questions
Who can join the NCT04597281 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 7 Years, studying Obesity, Childhood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04597281 currently recruiting?
Yes, NCT04597281 is actively recruiting participants. Contact the research team at lmoreno@unizar.es for enrollment information.
Where is the NCT04597281 trial being conducted?
This trial is being conducted at Córdoba, Spain, Santiago de Compostela, Spain, Zaragoza, Spain.
Who is sponsoring the NCT04597281 clinical trial?
NCT04597281 is sponsored by Luis A. Moreno Aznar. The principal investigator is Luis A Moreno Aznar, MD, PhD at Universidad de Zaragoza. The trial plans to enroll 738 participants.
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