GENYAL Study to Childhood Obesity Prevention

NCT03419520 | Completed

• 1 other identifier: IMD PI0024
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Onset Obesity

Keywords

Schoolchildren; Overweight; Obesity; Polymorphisms; Genetics; Nutritional counseling; Healthy strategies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in energy intake

  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

  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

  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

  There will be an initial assessment at the beginning of the study

Study Arms (2)

Intervention group

EXPERIMENTAL

Schools receive healthy actions aimed to reduce the risk of developing obesity, along the study

Behavioral: Nutritional counseling

Control group

NO INTERVENTION

Schools monitored along the study but won't receive any healthy action.

Interventions

Nutritional counseling BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• IMDEA Food: lead

Study Sites (1)

IMDEA-Food

Madrid, 28049, Spain

Location

Related Publications (2)

• Marcos-Pasero H, Aguilar-Aguilar E, de la Iglesia R, Espinosa-Salinas I, Molina S, Colmenarejo G, Martinez JA, Ramirez de Molina A, Reglero G, Loria-Kohen V. "GENYAL" Study to Childhood Obesity Prevention: Methodology and Preliminary Results. Front Nutr. 2022 Mar 8;9:777384. doi: 10.3389/fnut.2022.777384. eCollection 2022.

  PMID: 35350411 DERIVED

• Marcos-Pasero H, Aguilar-Aguilar E, de la Iglesia R, Espinosa-Salinas I, Gomez-Patino M, Colmenarejo G, de Molina AR, Reglero G, Loria-Kohen V. Association of calcium and dairy product consumption with childhood obesity and the presence of a Brain Derived Neurotropic Factor-Antisense (BDNF-AS) polymorphism. Clin Nutr. 2019 Dec;38(6):2616-2622. doi: 10.1016/j.clnu.2018.11.005. Epub 2018 Nov 20.

  PMID: 30501916 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Overweight; Obesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Guilerrmo Reglero, Professor

  IMDEA Food

  STUDY DIRECTOR

• Ana Ramirez-de Molina, PhD

  IMDEA Food

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Nutritionist, PhD in Medicine. Researcher and Group leader of the Nutrition and Clinical Trials Unit

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 5, 2018
• Study Start: February 15, 2017
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

ES (1)