Clinical trial

A New Technological Intervention to Address Childhood Obesity:

Recruiting now · Not applicable · 1 countries · Registry ID NCT06409962

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 16 Years
SexAll
Healthy volunteersAccepted
ConditionBody Weight, Dyslipidemias, Musculoskeletal Diseases

Full registry 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

Treatments and study arms

Technological combination

Other

The 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.

Primary outcomes

Weight (kg)From 12 weeks (1st measurement) up 15th months (6th measurement)

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.

Height (m2)From 12 weeks (1st measurement) up 15th months (6th measurement)

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.

Percentage Lean Mass (LM) (%)From 12 weeks (1st measurement) up 15th months (6th measurement)

The lean fat, calculated in percentage, will be obtained using a validated weight machine, alongside a body composition monitor such as the BF511.

Percentage Fat Mass (FM) (%)1st month, 3 month, 6 month, 9 month, 12th and 15th month

The lean fat, calculated in percentage, will be obtained using a validated weight machine, alongside a body composition monitor such as the BF511.

Body Mass Index (kg/m2)From 12 weeks (1st measurement) up 15th months (6th measurement)

The Body Mass Index will be calculated using the percentiles according to age group and sex.

Waist circumference (cm)From 12 weeks (1st measurement) up 15th months (6th measurement)

The waist circumference (cm) of the children will be measured via an inextensible measuring tape at the initial visit (1st month or V0) and at the last visit (15th month or V6).The measurement follows the recommendations of the International Standards for Anthropometric Assessment

Hip circumference(cm)From 12 weeks (1st measurement) up 15th months (6th measurement)

The Hip circumference(cm) of the children will be measured via an inextensible measuring tape at the initial visit (1st month or V0) and at the last visit (15th month or V6).The measurement follows the recommendations of the International Standards for Anthropometric Assessment

Arm circumference (cm)From 12 weeks (1st measurement) up 15th months (6th measurement)

The arm circumference (cm) of the children will be measured via an inextensible measuring tape at the initial visit (1st month or V0) and at the last visit (15th month or V6).The measurement follows the recommendations of the International Standards for Anthropometric Assessment

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Colegio Virgen del Carmen🇪🇸 Córdoba, Spain
Manuel Gumaz RoldanContact