Clinical trial NCT06409962: A New Technological Intervention to Address Childhood Obesity:
Official title: A New Technological Intervention to Address Childhood Obesity: Approach to Multidimensional Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Weight
Dyslipidemias
Musculoskeletal Diseases
Keywords: pediatric
body mass index
intervention
anthopometric
blood pressure
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
Collaborators: name: Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)
First posted: 2024-05-10
Enrollment: 215
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our proposed intervention, which integrates nutritional intervention with the use of innovative technologies, holds significant potential for yielding tangible outcomes in the prevention and management of this condition within the region. By doing so, it mitigates the risk of overweight and obesity-related pathologies in adulthood.

The inclusion of both experimental and control groups in the sample distribution will facilitate an effective evaluation of the nutritional intervention, offering concrete data on the efficacy of the implemented strategies. Furthermore, the comprehensive assessment encompassing anthropometric measurements, biometric data, and physical activity records will provide a detailed understanding of the intervention's effects on the school population.
Primary purpose: PREVENTION

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.

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 4.9% (31.5 million) to 6% (40.6 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 33.4%. In general, the country's 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 family's socioeconomic level.

In Spain, Andalusia is one of the autonomous communities with a lower income index (0.67) and a lower average expenditure on public health at 0.33%. However, the community puts in the most effort to implement policies against obesity, with a score of 5.19.

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 children's 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.

Eligibility criteria: Inclusion Criteria:

* Students from the school
* Pediatric from age 6 to 16
* Students from the school that confirmed approval
* Signed informed consent by the minor
* Signed informed consent by the minor's parents or guardians.

Exclusion Criteria:

* Presence of HbA1c levels below 5.7%
* Presence of HbA1c levels above 6.4%
* Presence of pathological metabolic diseases, such as diabetes or metabolic syndrome
* Presence of other diseases related to intestinal integrity or skin issues.
* Lack of the signed informed consent by the minor and legal guardian

Primary outcomes:
measure: Weight (kg)
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
measure: Height (m2)
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
measure: Percentage Lean Mass (LM) (%)
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
measure: Percentage Fat Mass (FM) (%)
timeFrame: 1st month, 3 month, 6 month, 9 month, 12th and 15th month
measure: Body Mass Index (kg/m2)
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
measure: Waist circumference (cm)
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
measure: Hip circumference(cm)
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
measure: Arm circumference (cm)
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
measure: Calf circumference (cm)
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
measure: Validated nutritional assessment questionnaire: adherence to the Mediterranean diet (KIDMED)
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
measure: Food Consumption Frequency
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
measure: Blood pressure
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
Secondary outcomes:
measure: 3D avatar system for anthropometric measures
timeFrame: From 12 weeks (1st measurement) up 15th months (6th measurement)
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Colegio Virgen del Carmen
Study officials:
affiliation: Universidad de Córdoba
name: Manuel Vaquero Abellan, MD, Msc, PhD
role: STUDY_DIRECTOR
affiliation: Maimónides Biomedical Research Institute of Córdoba
name: Manuel Vaquero Alvárez, MD, Msc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Primary Care, Jaen
name: Isabel Blancas Sanchez, MD, Msc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blancas-Sanchez IM, Del Rosal Jurado M, Aparicio-Martinez P, Quintana Navarro G, Vaquero-Abellan M, Castro Jimenez RA, Fonseca Pozo FJ. A Mediterranean-Diet-Based Nutritional Intervention for Children with Prediabetes in a Rural Town: A Pilot Randomized Controlled Trial. Nutrients. 2022 Sep 1;14(17):3614. doi: 10.3390/nu14173614.