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MEditerranean LIfestyle in Pediatric Obesity Prevention (MELI-POP)

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ClinicalTrials.gov Identifier: NCT04597281
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Instituto Maimónides de Investigación Biomédica de Córdoba
Fundación del Instituto de Investigación Sanitaria de Santiago
Information provided by (Responsible Party):
Luis A. Moreno Aznar, Universidad de Zaragoza

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Other: Lifestyle intervention Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 738 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: MEditerranean LIfestyle in Pediatric Obesity Prevention
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2032
Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Lifestyle intervention
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)
No Intervention: Usual care
General care by their pediatricians.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of obesity [ Time Frame: 10 years ]
    Number of children having normal-weight at the baseline measurement and having obesity at follow-up.


Secondary Outcome Measures :
  1. Body composition [ Time Frame: 10 years ]
    Fat mass index assessed using skinfold thickness measurements.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597281


Contacts
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Contact: Luis A Moreno Aznar, MD, PhD +34976761000 ext 4457 lmoreno@unizar.es

Locations
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Spain
Instituto Maimónides de Investigación Biomédica de Córdoba Recruiting
Córdoba, Spain, 14004
Contact: María Mercedes Gil Campos, MD, PhD    +34957213700    mercedes_gil_campos@yahoo.es   
Fundación del Instituto de Investigación Sanitaria de Santiago Recruiting
Santiago De Compostela, Spain, 15706
Contact: María Rosaura Leis Trabazo, MD, PhD    +34981955308    mariarosaura.leis@usc.es   
Instituto de Investigación Sanitaria Aragón Recruiting
Zaragoza, Spain, 50009
Contact: Luis A Moreno aznar, MD. PhD    +34976761000 ext 4457    lmoreno@unizar.es   
Sponsors and Collaborators
Luis A. Moreno Aznar
Instituto Maimónides de Investigación Biomédica de Córdoba
Fundación del Instituto de Investigación Sanitaria de Santiago
Investigators
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Principal Investigator: Luis A Moreno Aznar, MD, PhD Universidad de Zaragoza
More Information
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Responsible Party: Luis A. Moreno Aznar, Professor, Universidad de Zaragoza
ClinicalTrials.gov Identifier: NCT04597281    
Other Study ID Numbers: PI18/00666
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The plan is to allow other researchers to use the data obtained in the study is this is approved byut the corresponding responsible persons.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: At the end of the trial
Access Criteria: Approval of an analysis protocol by the study's steering committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight