MEditerranean LIfestyle in Pediatric Obesity Prevention

NCT ID: NCT04597281

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 738 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2032-12-31

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.

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

Conditions

Obesity, Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lifestyle intervention

Intervention Type: 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)

Usual care

General care by their pediatricians.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Maimónides de Investigación Biomédica de Córdoba

UNKNOWN

Sponsor Role: collaborator

Fundación del Instituto de Investigación Sanitaria de Santiago

UNKNOWN

Sponsor Role: collaborator

Luis A. Moreno Aznar

OTHER

Sponsor Role: lead

Responsible Party

Luis A. Moreno Aznar

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Luis A Moreno Aznar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

Locations

Instituto Maimónides de Investigación Biomédica de Córdoba

Córdoba, , Spain

Site Status: RECRUITING

Fundación del Instituto de Investigación Sanitaria de Santiago

Santiago de Compostela, , Spain

Site Status: RECRUITING

Instituto de Investigación Sanitaria Aragón

Zaragoza, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Luis A Moreno Aznar, MD, PhD

Role: CONTACT

lmoreno@unizar.es

+34976761000 ext. 4457

Facility Contacts

María Mercedes Gil Campos, MD, PhD

Role: primary

mercedes_gil_campos@yahoo.es

+34957213700

María Rosaura Leis Trabazo, MD, PhD

Role: primary

mariarosaura.leis@usc.es

+34981955308

Luis A Moreno aznar, MD. PhD

Role: primary

lmoreno@unizar.es

+34976761000 ext. 4457

Other Identifiers

PI18/00666

Identifier Type: -

Identifier Source: org_study_id