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Clinical Trials/NCT05741879
NCT05741879
Completed
Not Applicable

Gamified Exercise Intervention to Improve Children's Adherence to 24-hour Movement Recommendations in a Family-Based Health Setting: "3,2,1 Move on Crossover Study".

Universidad Pública de Navarra1 site in 1 country100 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Inactivity
Sponsor
Universidad Pública de Navarra
Enrollment
100
Locations
1
Primary Endpoint
Changes in 24-h movement behaviors (accelerometers) sedentary time.
Status
Completed
Last Updated
last year

Overview

Brief Summary

Physical inactivity is the fourth most important risk factor for mortality worldwide and it contributes to weight gain and obesity. On the contrary, it is established that regular physical activity is a prevention and managerial factor of these non-communicable diseases. Therefore, the goal of this study is to design and evaluate the effectiveness of a 12-week physical exercise and lifestyle improvement training program carried out in a family environment, through a web platform, and with "online" supervision. This platform will improve the physical conditioning and adherence to PE in a "family environment", and to promote good development of the child through physical activities and exercises that can be done as a family at home and/or outside.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participants without any physical or mental disorders that would prevent them from completing the assessments tests or participating in the exercise intervention program
  • One parent/guardian must answer the questionnaires
  • Informed consent from the participants parent(s)/guardian(s)

Exclusion Criteria

  • Participants with psychiatric disorders or chronic illness that limits their participation in physical activities
  • Participants who do not comply with the established procedures
  • Participants who do not understand the Spanish language

Outcomes

Primary Outcomes

Changes in 24-h movement behaviors (accelerometers) sedentary time.

Time Frame: Baseline, 12 Week, and 24 Week

During their visit to Navarrabiomed, participants will receive a (GENEActiv, Activinsights, Kimbolton, UK) accelerometer that will objectively measure their 24-hour movement behaviors (physical activity, sedentary behaviors, and sleep). The participants will wear the accelerometer for seven consecutive days. Additionally, this accelerometer data will be supplemented with a diary to validate sleep time and (non)wear time.

Secondary Outcomes

  • Changes in executive function.(Baseline, 12 Week, and 24 Week)
  • Changes in health-related physical fitness.(Baseline, 12 Week, and 24 Week)
  • Changes in quality of life.(Baseline, 12 Week, and 24 Week)
  • Changes in body composition.(Baseline, 12 Week, and 24 Week)
  • Changes in Basic Motor Skills.(Baseline, 12 Week, and 24 Week)
  • Changes in muscle composition.(Baseline, 12 Week, and 24 Week)
  • Changes in 24-h movement behaviors (self-reported).(Baseline, 12 Week, and 24 Week)
  • Changes in Child Self-Regulation & Behavior.(Baseline, 12 Week, and 24 Week)

Study Sites (1)

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