GENYAL Study to Childhood Obesity Prevention
Condition: Childhood Onset Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Nutritional counseling
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Prevention
Keywords: Schoolchildren; Overweight; Obesity; Polymorphisms; Genetics; Nutritional counseling; Healthy strategies