Actively Recruiting

Phase Not Applicable
Age: 6Years - 16Years
All Genders
Healthy Volunteers
ID06409962

A New Technological Intervention to Address Childhood Obesity: Approach to Multidimensional Intervention

Led by Universidad de Córdoba · Updated on 2024-06-11

215

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

Sponsors

U

Universidad de Córdoba

Lead Sponsor

I

Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Childhood obesity is a growing public health issue worldwide and especially in Spain, where it is more prevalent in southern regions. Factors contributing to this include dietary habits, physical inactivity, socioeconomic status, and family environment. The study aims to evaluate the impact of a nutritional intervention administered by school nurses to address childhood obesity and its health consequences, including heart and musculoskeletal issues. The study compares two groups of schoolchildren aged 6 to 16. One group receives a technological intervention using podcasts, gamification, and virtual reality to promote nutrition education and healthy behaviors. The control group receives traditional brochures with nutritional information. Both groups are monitored through various measurements and biometric data collected over a 15-month period. Participants will be assessed regularly for weight, height, body composition, circumference measures, blood pressure, and adherence to the Mediterranean diet using questionnaires. Additional evaluations include a 3D avatar system for anthropometric measures. The study includes data collection at multiple timepoints from 12 weeks up to 15 months, with ongoing monitoring to assess the effectiveness of the intervention and potential health improvements.

CONDITIONS

Brief Title

A New Technological Intervention to Address Childhood Obesity:

Who Can Participate

Age: 6Years - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Students from the school
  • Children aged 6 to 16 years
  • Students with confirmed approval to participate
  • Signed informed consent by the minor
  • Signed informed consent by the minor's parents or guardians
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 15 months

Participants receive a nutritional intervention through either a technological combination including workshops, counseling, cooking classes, and physical activity promotion, or a traditional brochure-based intervention to support healthy eating habits and lifestyle changes.

Regular assessments approximately every 3 months during the 15 months

Trial Site Locations

Total: 1 location

1

Colegio Virgen del Carmen

Córdoba, Spain, 14011

Actively Recruiting

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Research Team

M

Manuel J Guzmán Roldán, Msc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

A Mediterranean-Diet-Based Nutritional Intervention for Children with Prediabetes in a Rural Town: A Pilot Randomized Controlled Trial.

Isabel María Blancas-Sánchez, María Del Rosal Jurado, Pilar Aparicio-Martínez...

https://pubmed.ncbi.nlm.nih.gov/36079871