MEditerranean LIfestyle in Pediatric Obesity Prevention
MELI-POP
1 other identifier
interventional
738
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2032
ExpectedOctober 22, 2020
October 1, 2020
4.3 years
September 28, 2020
October 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of obesity
Number of children having normal-weight at the baseline measurement and having obesity at follow-up.
10 years
Secondary Outcomes (1)
Body composition
10 years
Study Arms (2)
Mediterranean lifestyle
EXPERIMENTALMediterranean 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.
Usual care
NO INTERVENTIONGeneral care by their pediatricians.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Instituto Maimónides de Investigación Biomédica de Córdoba
Córdoba, 14004, Spain
Fundación del Instituto de Investigación Sanitaria de Santiago
Santiago de Compostela, 15706, Spain
Instituto de Investigación Sanitaria Aragón
Zaragoza, 50009, Spain
Related Publications (1)
De Miguel-Etayo P, Flores-Rojas K, Vazquez-Cobela R, Jurado-Castro JM, Larruy-Garcia A, Picans-Leis R, Castro-Collado C, Pastor-Villaescusa B, Llorente-Cantarero FJ, Aguilera CM, Gil-Campos M, Leis R, Moreno LA; MELI-POP Study group. MELI-POP Study: MEditerranean LIfestyle in Pediatric Obesity Prevention. Study protocol for a randomized controlled trial. BMC Public Health. 2025 Nov 5;25(1):3791. doi: 10.1186/s12889-025-24351-2.
PMID: 41194137DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis A Moreno Aznar, MD, PhD
Universidad de Zaragoza
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 28, 2020
First Posted
October 22, 2020
Study Start
March 1, 2018
Primary Completion
June 30, 2022
Study Completion (Estimated)
December 31, 2032
Last Updated
October 22, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
- Time Frame
- At the end of the trial
- Access Criteria
- Approval of an analysis protocol by the study's steering committee
The plan is to allow other researchers to use the data obtained in the study is this is approved byut the corresponding responsible persons.