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Biomarkers of Physical Activity/health in Children and Adolescents

NCT05907785 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-23

No results posted yet for this study

Summary

This clinical trial is aimed to recruit a core cohort of children and adolescents, and to perform an educational intervention and follow-up study in a subgroup of volunteers from this core cohort, to obtain specific measurements and samples of interest in these volunteers that will be used for identification and validation of the biomarkers of physical activity (PA) and health.

Conditions

  • Physical Activity

Interventions

BEHAVIORAL

Educational intervention

The intervention will consist of recommendations to improve physical activity (PA) and dietary habits. It is based on the PAIDO Programme (www.programapaido.es), an outpatient family-based multidisciplinary programme that combines PA, education on nutrition, and behavioural therapy. It will last 6 months and improvement of metabolic health and body weight loss is expected, particularly in the groups with overweight and obesity. The dietary intervention will be focused on the promotion of the Mediterranean diet, with follow-up and advice from a dietitian-nutritionist. Participants will be encouraged in reducing sedentary behaviour (watching television, playing computer games, playing board games). Performance of aerobic and strength physical exercises will be scheduled, progressively increasing the intensity. Volunteers and their parents will participate in monthly sessions to follow-up on adherence to the PA and dietary recommendations and give personalized advice.

Sponsors & Collaborators

  • Fundación de Investigación Hospital General Universitario de Valencia

    collaborator UNKNOWN

  • Czech Academy of Sciences

    collaborator OTHER

  • Aix Marseille Université

    collaborator OTHER

  • Wageningen University

    collaborator OTHER

  • Fundació d'investigació Sanitària de les Illes Balears

    lead OTHER_GOV

Principal Investigators

  • Catalina Picó, Prof. · Fundació d'investigació Sanitària de les Illes Balears

  • Empar Lurbe, Prof. · General University Hospital Consortium of Valencia

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-10-15
Completion
2024-10-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05907785 on ClinicalTrials.gov