GENYAL Study to Childhood Obesity Prevention
Primary Purpose
Childhood Onset Obesity
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nutritional counseling
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Onset Obesity focused on measuring Schoolchildren, Overweight, Obesity, Polymorphisms, Genetics, Nutritional counseling, Healthy strategies
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.
Sites / Locations
- IMDEA-Food
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Schools receive healthy actions aimed to reduce the risk of developing obesity, along the study
Schools monitored along the study but won't receive any healthy action.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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)
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03419520
Brief Title
GENYAL Study to Childhood Obesity Prevention
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
March 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IMDEA Food
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Onset Obesity
Keywords
Schoolchildren, Overweight, Obesity, Polymorphisms, Genetics, Nutritional counseling, Healthy strategies
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
221 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Schools receive healthy actions aimed to reduce the risk of developing obesity, along the study
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Schools monitored along the study but won't receive any healthy action.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the percentage of children with a diagnosis of obesity
Description
The International Obesity Task Force classification will be used to the 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.
Secondary Outcome Measure Information:
Title
Changes in energy intake
Description
A 48h food record and the DIAL (Alce Ingenieria) software will be used to evaluate the energy intake (Kcal) of the studied population
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.
Title
Changes in body fat mass percentage
Description
The fat mass percentage will be measured using the Body Composition Monitor (BF511- OMRON HEALTHCARE UK, LT, Kyoto, Japan)
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.
Title
Physical activity
Description
A 24h physical activity questionnaire and the Institute of Medicine of the National Academies classification will be used to measure the physical activity level
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.
Title
Genetic predisposition to develop obesity
Description
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)
Time Frame
There will be an initial assessment at the beginning of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilerrmo Reglero, Professor
Organizational Affiliation
IMDEA Food
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ana Ramirez-de Molina, PhD
Organizational Affiliation
IMDEA Food
Official's Role
Study Director
Facility Information:
Facility Name
IMDEA-Food
City
Madrid
ZIP/Postal Code
28049
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35350411
Citation
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.
Results Reference
derived
PubMed Identifier
30501916
Citation
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.
Results Reference
derived
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GENYAL Study to Childhood Obesity Prevention
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