MEditerranean LIfestyle in Pediatric Obesity Prevention

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 7
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Spain
Instituto Maimónides de Investigación Biomédica de Córdoba
RECRUITING
Córdoba
Fundación del Instituto de Investigación Sanitaria de Santiago
RECRUITING
Santiago De Compostela
Instituto de Investigación Sanitaria Aragón
RECRUITING
Zaragoza
Contact Information
Primary
Luis A Moreno Aznar, MD, PhD
lmoreno@unizar.es
+34976761000
Time Frame
Start Date: 2018-03-01
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 738
Treatments
Experimental: Mediterranean lifestyle
Mediterranean lifestyle, including dietary advice and physical activity advice. In addition, families receive extra-virgin olive oil and fish and two sessions of physical activity per week, for free.
No_intervention: Usual care
General care by their pediatricians.
Related Therapeutic Areas
Sponsors
Collaborators: Fundación del Instituto de Investigación Sanitaria de Santiago, Instituto Maimónides de Investigación Biomédica de Córdoba
Leads: Luis A. Moreno Aznar

This content was sourced from clinicaltrials.gov