GENYAL Study to Childhood Obesity Prevention

NCT ID: NCT03419520

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2017-03-30

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

Study Design

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

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Nutritional counseling

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutritional counseling

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 Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IMDEA Food

OTHER

Sponsor Role: lead

Responsible Party

Viviana Loria Kohen

Senior Nutritionist, PhD in Medicine. Researcher and Group leader of the Nutrition and Clinical Trials Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guilerrmo Reglero, Professor

Role: STUDY_DIRECTOR

IMDEA Food

Ana Ramirez-de Molina, PhD

Role: STUDY_DIRECTOR

IMDEA Food

Locations

IMDEA-Food

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35350411 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30501916 (View on PubMed)

Other Identifiers

IMD PI0024

Identifier Type: -

Identifier Source: org_study_id