A New Technological Intervention to Address Childhood Obesity:
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-16
SponsorUniversidad de Córdoba
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Students from the school
Pediatric from age 6 to 16
Students from the school that confirmed approval
Signed informed consent by the minor
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Technological combination
Other interventionThe intervention comprises workshops, individualized counseling, cooking classes, and physical activity promotion. It emphasizes nutritional education, hands-on cooking, and behavioral modification techniques. Participants receive personalized guidance and resources to make sustainable dietary and lifestyle changes. Social support networks foster motivation and accountability. By combining these components, the intervention aims to empower participants with the knowledge, skills, and support needed for long-term health improvements.
Treatment groups
215 Participants
are divided into 2 treatment groupsGroup A: Technological interventionExperimental treatment 1 intervention
Group B: No-technological intervention: traditional brochureNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Weight (kg)
Weight, as a pivotal anthropometric measure, will be quantified using a validated weight machine, alongside a body composition monitor such as the BF511. The validated weight machine adheres to established calibration standards, ensuring precision and consistency in measurements. It employs advanced technology to accurately assess an individual's weight in kilograms (kg), providing reliable data for scientific analyses.
Time frame
From 12 weeks (1st measurement) up 15th months (6th measurement)2
Height (m2)
Height will be registered in meters squared (m\^2) for its precise evaluation. Employing a validated tachymeter, a specialized instrument designed for accurate measurements, ensures meticulous assessment of height.
Time frame
From 12 weeks (1st measurement) up 15th months (6th measurement)3
Percentage Lean Mass (LM) (%)
The lean fat, calculated in percentage, will be obtained using a validated weight machine, alongside a body composition monitor such as the BF511.
Time frame
From 12 weeks (1st measurement) up 15th months (6th measurement)4
Percentage Fat Mass (FM) (%)
The lean fat, calculated in percentage, will be obtained using a validated weight machine, alongside a body composition monitor such as the BF511.
Time frame
1st month, 3 month, 6 month, 9 month, 12th and 15th monthSecondary outcomes
1
3D avatar system for anthropometric measures
The validation of avatar systems based on artificial vision involves assessing the accuracy, reliability, and effectiveness of virtual representations controlled by artificial intelligence algorithms. These avatars, generated using artificial vision technology, mimic human-like behavior and interactions within virtual environments. Validation encompasses rigorous testing to ensure that avatars accurately interpret and respond to visual inputs, such as facial expressions or gestures, in a manner consistent with human perception. The validation of avatar systems based on artificial vision involves assessing the accuracy, reliability, and effectiveness of virtual representations controlled by artificial intelligence algorithms. The results of the model will provide, using the height and weight previously measured with the Body Composition validated weight scale, will be obtained the arm, waist, calf and arm circumferences.
Time frame
From 12 weeks (1st measurement) up 15th months (6th measurement)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad de Córdoba
Lead sponsor
Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)
Collaborator
Source ClinicalTrials.gov