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Obesity, ChildhoodMELI-POPNCT04597281

MEditerranean LIfestyle in Pediatric Obesity Prevention

A study testing Lifestyle intervention in people with Obesity, Childhood, run by Luis A. Moreno Aznar at 3 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 3 to 7 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
738 participants
Where
3 sitesSpain
Study dates
1 Mar 2018to 31 Dec 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Luis A Moreno Aznar, MD, PhD contact

+34976761000 ext. 4457

lmoreno@unizar.es

Spain3 sites, 3 recruiting

  • Instituto Maimónides de Investigación Biomédica de Córdoba

    Córdoba, 14004

    María Mercedes Gil Campos, MD, PhD, +34957213700, mercedes_gil_campos@yahoo.es

    Recruiting

  • Fundación del Instituto de Investigación Sanitaria de Santiago

    Santiago de Compostela, 15706

    María Rosaura Leis Trabazo, MD, PhD, +34981955308, mariarosaura.leis@usc.es

    Recruiting

  • Instituto de Investigación Sanitaria Aragón

    Zaragoza, 50009

    Luis A Moreno aznar, MD. PhD, +34976761000 ext. 4457, lmoreno@unizar.es

    Recruiting

Other trials in Spain

About this study

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.

Read the detailed description

Hypothesis A healthy lifestyle, based on the promotion of the Mediterranean dietary pattern and regular physical activity, decrease the likelihood of developing obesity and cardio-metabolic abnormalities during childhood and adolescence.

Objectives

To assess, in a cohort of children at high risk of obesity, if an intervention during childhood and adolescence, considering a healthy lifestyle based on the promotion of Mediterranean dietary pattern and regular physical activity, when compared with a control group Main objective

  1. To decrease obesity incidence 5 and 10 years after the start of the intervention Secondary objectives
  2. To improve body composition (Body mass index z-score, Fat mass index z-score, waist circumference) assessed in a yearly basis
  3. To improve health-related physical fitness assessed in a yearly basis
  4. To improve cardiovascular risk factor (classic and omics) associated with obesity 1, 3, 5 and 10 years after the start of the intervention Intermediary objectives
  5. To increase the adherence to a Mediterranean dietary pattern 1, 3, 5 and 10 years after the start of the intervention
  6. To increase the adherence to age-specific physical activity recommendations 1, 3, 5 and 10 years after the start of the intervention
Being tested
Lifestyle intervention
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionOther

    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)

Study groups in NCT04597281
Study groupRoleWhat they receive
Mediterranean lifestyleExperimentalMediterranean 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.
Receives: Other: Lifestyle intervention
Usual careNo interventionGeneral care by their pediatricians.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of obesity

    Number of children having normal-weight at the baseline measurement and having obesity at follow-up.

    Measured: 10 years

Secondary outcomes (1)

  1. Body composition

    Fat mass index assessed using skinfold thickness measurements.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start1 Mar 2018
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
738 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04597281
Sponsor's protocol ID
PI18/00666
Acronym
MELI-POP
Status last verified
Oct 2020
First submitted
28 Sep 2020
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The plan is to allow other researchers to use the data obtained in the study is this is approved byut the corresponding responsible persons.

Publications

  • Larruy-Garcia A, De Miguel-Etayo P, Gil-Campos M, Esteban LM, Picans-Leis R, Pastor-Villaescusa B, Vazquez-Cobela R, Flores-Rojas K, Leis R, Moreno LA. A Mediterranean lifestyle obesity prevention intervention in preschoolers at risk: MELI-POP Study-a randomized controlled trial. Eur J Pediatr. 2026 Mar 24;185(4):207. doi: 10.1007/s00431-026-06844-3.

    PubMed 41874667

  • 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.

    PubMed 41194137

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Obesity, Childhood, run by Luis A. Moreno Aznar at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luis A Moreno Aznar, MD, PhD (+34976761000 ext. 4457, lmoreno@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of obesity (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04597281, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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