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NCT Number: NCT04597281

MEditerranean LIfestyle in Pediatric Obesity Prevention

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.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Maimónides de Investigación Biomédica de Córdoba, Córdoba, Spain

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About this study

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

  • To decrease obesity incidence 5 and 10 years after the start of the intervention Secondary objectives
  • To improve body composition (Body mass index z-score, Fat mass index z-score, waist circumference) assessed in a yearly basis
  • To improve health-related physical fitness assessed in a yearly basis
  • 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
  • To increase the adherence to a Mediterranean dietary pattern 1, 3, 5 and 10 years after the start of the intervention
  • To increase the adherence to age-specific physical activity recommendations 1, 3, 5 and 10 years after the start of the intervention

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lifestyle intervention

Other

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)

Primary outcomes

  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 outcomes

  1. Body composition

    Time frame: 10 years

    Fat mass index assessed using skinfold thickness measurements.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis A Moreno Aznar, MD, PhD

CONTACT

[email protected]

+34976761000 ext. 4457

Sponsors and collaborators

Lead sponsor

Luis A. Moreno Aznar

Other

Collaborators

  • Fundación del Instituto de Investigación Sanitaria de Santiago
  • Instituto Maimónides de Investigación Biomédica de Córdoba

Registry information

Acronym: MELI-POP

Important dates

Study start
2018
Primary completion
2022
Study completion
2032
First posted
Oct 22, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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