GENYAL Study to Childhood Obesity Prevention

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Childhood Onset Obesity

Intervention / Treatment
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* Behavioral: Nutritional counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The present study is an observational and long-term intervention study. There is an initial evaluation carried out on all children involved in the study 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 group is going to receive nutritional education aimed to reduce the risk of developing obesity.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Schools receive healthy actions aimed to reduce the risk of developing obesity, along the study | Behavioral: Nutritional counseling<br>* 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.<br>|
| No Intervention: Control group<br>Schools monitored along the study but won't receive any healthy action. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the percentage of children with a diagnosis of obesity | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schoolchildren, Overweight, Obesity, Polymorphisms, Genetics, Nutritional counseling, Healthy strategies