GENYAL Study to Childhood Obesity Prevention

August 9, 2019 updated by: Viviana Loria Kohen, IMDEA Food

Detection of Genetic Polymorphisms Associated With Obesity and Its Complications in Schoolchildren Within the Madrid Community, and Evaluation of Health Actions for Reducing the Risk

Obesity is a multifactorial, complex, chronic disease of special concern. It is originated as an interaction between genetic predisposition and environmental factors. Thus, knowledge of gene-diet interactions is especially important. However, most studies analyzing the efficacy of diet on body weight have not considered the genetic variability among the population.

Childhood and adolescence are critical periods in the development of obesity. This is because, on one hand, during infancy dietary patterns are being implemented. Moreover, it has been described that around the age of 6 it occurs the adiposity rebound, which consists in the increase in body mass index (BMI) that occurs after reaching a lowest point in infancy. It is believed that an early adiposity rebound is associated with a higher risk of developing obesity in the following years. The prevalence of overweight and obese children is increasing every year. Specifically, according to the World Health Organization (WHO) the number of overweight or obese children aged 0 to 5 years, increased from 32 million globally in 1990 to 41 million in 2016. Regarding Spanish children, they are amongst the highest levels of overweight and obesity in Europe. Precisely, in 2015 the Spanish Agency for Consumer Affairs, Food Safety and Nutrition reported 23.2 % overweight and 18.1 % obese Spanish children, according to the ALADINO study.

Considering the previous elaboration, we hypothesized that an early identification of SNPs associated with obesity will improve the strategies applied for its prevention. Moreover, an adequate nutritional counseling and a healthy lifestyle implementation during childhood will contribute to a higher quality of life in the adulthood.

Thus, schools from the Madrid Community agreeing to participate in the study will be randomly assigned to either control or intervention groups. Then, an initial evaluation where 26 SNPs associated with obesity and its related comorbidities will be carried out in all children involved in the study, in addition to anthropometric, blood pressure measurements, and physical activity and dietary patterns evaluation. Then, each group will be divided in two according to the genetic risk (high vs low) for presenting obesity and its related comorbidities. The initial evaluation was performed on all children at 1st and 2nd grades and it is going to be followed by 3 monitoring actions in the following years where the progression of anthropometric measurements and dietary habits are going to be studied. Besides, the intervention schools are going to receive healthy actions along the study aimed to reduce the risk of developing obesity.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain, 28049
        • IMDEA-Food

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Children at 1st and 2nd grades from schools of the Madrid Community that have accepted to participate in the study, whose parents have approved and signed the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Schools receive healthy actions aimed to reduce the risk of developing obesity, along the study
Schoolchildren, parents and teachers from intervention schools, will regularly receive nutrition and healthy lifestyle guidelines performed by nutritionists. Moreover, workshops aimed to reinforce the healthy habits will also be held along the study.
No Intervention: Control group
Schools monitored along the study but won't receive any healthy action.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the percentage of children with a diagnosis of obesity
Time Frame: There will be an initial assessment followed by 2 evaluations in the two consecutive years and a third and final evaluation 4 years after the initial assessment.
The International Obesity Task Force classification will be used to the diagnosis of obesity
There will be an initial assessment followed by 2 evaluations in the two consecutive years and a third and final evaluation 4 years after the initial assessment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in energy intake
Time Frame: There will be an initial assessment followed by 2 evaluations in the two consecutive years and a third and final evaluation 4 years after the initial assessment.
A 48h food record and the DIAL (Alce Ingenieria) software will be used to evaluate the energy intake (Kcal) of the studied population
There will be an initial assessment followed by 2 evaluations in the two consecutive years and a third and final evaluation 4 years after the initial assessment.
Changes in body fat mass percentage
Time Frame: There will be an initial assessment followed by 2 evaluations in the two consecutive years and a third and final evaluation 4 years after the initial assessment.
The fat mass percentage will be measured using the Body Composition Monitor (BF511- OMRON HEALTHCARE UK, LT, Kyoto, Japan)
There will be an initial assessment followed by 2 evaluations in the two consecutive years and a third and final evaluation 4 years after the initial assessment.
Physical activity
Time Frame: There will be an initial assessment followed by 2 evaluations in the two consecutive years and a third and final evaluation 4 years after the initial assessment.
A 24h physical activity questionnaire and the Institute of Medicine of the National Academies classification will be used to measure the physical activity level
There will be an initial assessment followed by 2 evaluations in the two consecutive years and a third and final evaluation 4 years after the initial assessment.
Genetic predisposition to develop obesity
Time Frame: There will be an initial assessment at the beginning of the study
A total of 26 SNPs related to obesity development will be analysed using saliva samples and the QuantStudio™ 12K Flex (Life Technologies) equipment. (Machine learning predictive modeling)
There will be an initial assessment at the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Guilerrmo Reglero, Professor, IMDEA Food
  • Study Director: Ana Ramirez-de Molina, PhD, IMDEA Food

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

March 30, 2017

Study Completion (Actual)

March 30, 2017

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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