Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409962
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-04-17
Brief Title:
A New Technological Intervention to Address Childhood Obesity
Sponsor:
Universidad de Córdoba
Organization:
Universidad de Córdoba
Study Overview
Official Title:
A New Technological Intervention to Address Childhood Obesity Approach to Multidimensional Intervention
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NURSPEDIAOBE
Brief Summary:
Childhood obesity is a global public health issue with rising prevalence rates In Spain the problem is significant particularly in the southern regions Factors contributing to childhood obesity include dietary habits lack of physical activity and socioeconomic influences
Efforts to address childhood obesity in Spain include various programs focusing on dietary modification increased physical activity and family involvement Despite these initiatives there is a need for continued intervention as changing dietary and lifestyle patterns have led to reduced fruit and vegetable consumption and increased sedentary behavior among children
Childhood obesity has concerning health implications including heart-related issues Echocardiography plays a vital role in early detection
Given the limited research on the impact of childhood obesity on musculoskeletal development and mobility a comprehensive study is needed to analyze its prevalence and associated factors The study aims to assess the effectiveness of nutritional interventions administered by school nurses
In summary childhood obesity in Spain is a growing concern with multifaceted causes and health implications Ongoing efforts are required to combat this issue and promote healthier lifestyles among children
Efforts to address childhood obesity in Spain include various programs focusing on dietary modification increased physical activity and family involvement Despite these initiatives there is a need for continued intervention as changing dietary and lifestyle patterns have led to reduced fruit and vegetable consumption and increased sedentary behavior among children
Childhood obesity has concerning health implications including heart-related issues Echocardiography plays a vital role in early detection
Given the limited research on the impact of childhood obesity on musculoskeletal development and mobility a comprehensive study is needed to analyze its prevalence and associated factors The study aims to assess the effectiveness of nutritional interventions administered by school nurses
In summary childhood obesity in Spain is a growing concern with multifaceted causes and health implications Ongoing efforts are required to combat this issue and promote healthier lifestyles among children
Detailed Description:
An elevated Body Mass Index BMI in the child population represents a significant global public health concern According to the World Health Organization WHO overweight occurs in children aged 6-19 when the BMI exceeds one or more standard deviations from the median established in WHO child growth patterns
Epidemiological data reflects that since the late 20th century childhood obesity has increased from 49 315 million to 6 406 million worldwide According to data from the Childhood Obesity Surveillance Initiative COSI within the European Union EU children in Spain aged 6-9 have a 42 overweight rate and a 19 obesity rate In comparison girls have a 41 overweight rate and a 17 obesity rate positioning Spain as the fourth EU country with the highest prevalence of overweight and obesity in children
Within the national territory 4 out of 10 schoolchildren have excess weight with the highest prevalence in the southern regions The autonomous community with the lowest incidence of childhood overweight is Navarra with 15 and the highest is the Region of Murcia with 40 Andalusians present a high prevalence rate of 334 In general the countrys northern regions have lower figures while the southern region has the highest rates of childhood overweight It has also been observed that there is a higher likelihood of being overweight in rural areas than in urban areas
This could be due to regional differences in habits during the three critical periods for the development of childhood obesity the preconception period involving maternal factors the first 1000 days of life 9 months of pregnancy 2 years of life and the adiposity rebound between 5-7 years Childhood overweight is also highly influenced by factors such as maternal overweight early introduction of complementary feeding before 6 months of age smoking during pregnancy low parental educational levels and the excessive use of screens such as mobile phones or tablets at an early age
The most relevant factors in overweight are diet physical inactivity physical activity and lifestyle habits However when it comes to minors all these factors are strongly influenced by the cultural social and institutional environment as well as the familys socioeconomic level
In Spain Andalusia is one of the autonomous communities with a lower income index 067 and a lower average expenditure on public health at 033 However the community puts in the most effort to implement policies against obesity with a score of 519
Numerous campaigns have been launched to prevent childhood obesity developed by the Spanish Agency for Consumer Affairs Food Safety and Nutrition AECOSAN as part of the nutrition physical activity and obesity prevention NAOS strategy Additionally the Andalusian Ministry of Health and Families has implemented plans such as Growing in Health Evaluation of Food Offer in Andalusian Schools 2019-2020 and the Health throughout Life campaign
All these programs coincide on three fundamental aspects when addressing childhood obesity interventions to modify dietary habits promoting balanced and healthy eating increasing fruit and vegetable consumption while minimizing sugar intake interventions to promote physical activity encouraging at least one hour of exercise daily and lastly family involvement interventions to achieve proper adherence to these changes
These interventions are necessary today because over the past decades there have been changes in eating patterns and diets resulting in a decrease in the consumption of fruits vegetables legumes and fresh products as well as an increase in the consumption of processed foods with higher sugar fat salt content and poorer nutritional quality According to COSI initiative data Spain is where children consume the least fruits and vegetables daily There have also been changes in physical activity with studies showing that 25 of Spanish children are sedentary
One of the direct consequences of childhood overweight is morphological heart alterations reflected in left ventricular hypertrophy and cardiac diastolic alterations Numerous scientific studies have established a close relationship between obesity in children and adolescents and an increase in epicardial fat which can lead to cardiac and vascular abnormalities In fact having a high BMI at a young age has become a significant risk factor for the premature development of cardiovascular diseases that were previously considered exclusive to adults These changes are visible through echocardiography especially in epicardial fat
As a non-invasive diagnostic tool Echocardiography has gained a fundamental role in early detection of these alterations in the pediatric population affected by an increase in epicardial fat Its early implementation allows for precise cardiac and vascular function assessment improving these young patients quality of life and prognosis These measurements and modifications have been analyzed recently although more data on younger populations and post-pandemic needs to be collected Furthermore to address this growing challenge it is crucial to raise awareness about the importance of maintaining a healthy weight early and promote research and the application of preventive and intervention strategies to reduce epicardial fat in the pediatric population
Due to all the aforementioned reasons coupled with the limited number of current publications that deeply analyze the consequences of childhood obesity on the development of the musculoskeletal system and childrens mobility it is essential to conduct a study of the population and subsequently intervene to promote healthy growth and development in children
Therefore the objective is to establish the impact of a nutritional intervention by a school nurse on a group of schoolchildren
Epidemiological data reflects that since the late 20th century childhood obesity has increased from 49 315 million to 6 406 million worldwide According to data from the Childhood Obesity Surveillance Initiative COSI within the European Union EU children in Spain aged 6-9 have a 42 overweight rate and a 19 obesity rate In comparison girls have a 41 overweight rate and a 17 obesity rate positioning Spain as the fourth EU country with the highest prevalence of overweight and obesity in children
Within the national territory 4 out of 10 schoolchildren have excess weight with the highest prevalence in the southern regions The autonomous community with the lowest incidence of childhood overweight is Navarra with 15 and the highest is the Region of Murcia with 40 Andalusians present a high prevalence rate of 334 In general the countrys northern regions have lower figures while the southern region has the highest rates of childhood overweight It has also been observed that there is a higher likelihood of being overweight in rural areas than in urban areas
This could be due to regional differences in habits during the three critical periods for the development of childhood obesity the preconception period involving maternal factors the first 1000 days of life 9 months of pregnancy 2 years of life and the adiposity rebound between 5-7 years Childhood overweight is also highly influenced by factors such as maternal overweight early introduction of complementary feeding before 6 months of age smoking during pregnancy low parental educational levels and the excessive use of screens such as mobile phones or tablets at an early age
The most relevant factors in overweight are diet physical inactivity physical activity and lifestyle habits However when it comes to minors all these factors are strongly influenced by the cultural social and institutional environment as well as the familys socioeconomic level
In Spain Andalusia is one of the autonomous communities with a lower income index 067 and a lower average expenditure on public health at 033 However the community puts in the most effort to implement policies against obesity with a score of 519
Numerous campaigns have been launched to prevent childhood obesity developed by the Spanish Agency for Consumer Affairs Food Safety and Nutrition AECOSAN as part of the nutrition physical activity and obesity prevention NAOS strategy Additionally the Andalusian Ministry of Health and Families has implemented plans such as Growing in Health Evaluation of Food Offer in Andalusian Schools 2019-2020 and the Health throughout Life campaign
All these programs coincide on three fundamental aspects when addressing childhood obesity interventions to modify dietary habits promoting balanced and healthy eating increasing fruit and vegetable consumption while minimizing sugar intake interventions to promote physical activity encouraging at least one hour of exercise daily and lastly family involvement interventions to achieve proper adherence to these changes
These interventions are necessary today because over the past decades there have been changes in eating patterns and diets resulting in a decrease in the consumption of fruits vegetables legumes and fresh products as well as an increase in the consumption of processed foods with higher sugar fat salt content and poorer nutritional quality According to COSI initiative data Spain is where children consume the least fruits and vegetables daily There have also been changes in physical activity with studies showing that 25 of Spanish children are sedentary
One of the direct consequences of childhood overweight is morphological heart alterations reflected in left ventricular hypertrophy and cardiac diastolic alterations Numerous scientific studies have established a close relationship between obesity in children and adolescents and an increase in epicardial fat which can lead to cardiac and vascular abnormalities In fact having a high BMI at a young age has become a significant risk factor for the premature development of cardiovascular diseases that were previously considered exclusive to adults These changes are visible through echocardiography especially in epicardial fat
As a non-invasive diagnostic tool Echocardiography has gained a fundamental role in early detection of these alterations in the pediatric population affected by an increase in epicardial fat Its early implementation allows for precise cardiac and vascular function assessment improving these young patients quality of life and prognosis These measurements and modifications have been analyzed recently although more data on younger populations and post-pandemic needs to be collected Furthermore to address this growing challenge it is crucial to raise awareness about the importance of maintaining a healthy weight early and promote research and the application of preventive and intervention strategies to reduce epicardial fat in the pediatric population
Due to all the aforementioned reasons coupled with the limited number of current publications that deeply analyze the consequences of childhood obesity on the development of the musculoskeletal system and childrens mobility it is essential to conduct a study of the population and subsequently intervene to promote healthy growth and development in children
Therefore the objective is to establish the impact of a nutritional intervention by a school nurse on a group of schoolchildren
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None