Gamified Family-based Health Exercise Intervention to Improve Adherence to 24-h Movement Behaviors Recommendations in Children.

NCT ID: NCT05741879

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Physical Inactivity Obesity, Childhood Sedentary Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Gamified online exercise in a family environment

Strength training Resistance training Flexibility training Basic motor skills training Executive function training

Group Type EXPERIMENTAL

Gamified exercise training

Intervention Type BEHAVIORAL

Participants will complete a 2-days-a-week online training routine with their families: Each session will include a Warm-Up/Activation phase (3 minutes: light intensity continuous training), a Training phase (10-26 minutes: 6-12 repetitions, 20-40" of work, 10-20" recovery), and a Cool Down phase (3 minutes: static and dynamic exercises). The exercises will be different each week and will increase in length and intensity accordingly. The sessions will be supervised by the participants parent(s) and/or guardian(s).

Standard care Non-supervised daily routines/activities

Non-supervised daily routines/activities

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

This group will be allocated to standard care and therefore no gamified online exercise training will be provided. They will continue to perform their daily routine/activities including their basic motor skills classes at school and their extracurricular sports and/or cultural activities.

Interventions

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Gamified exercise training

Participants will complete a 2-days-a-week online training routine with their families: Each session will include a Warm-Up/Activation phase (3 minutes: light intensity continuous training), a Training phase (10-26 minutes: 6-12 repetitions, 20-40" of work, 10-20" recovery), and a Cool Down phase (3 minutes: static and dynamic exercises). The exercises will be different each week and will increase in length and intensity accordingly. The sessions will be supervised by the participants parent(s) and/or guardian(s).

Intervention Type BEHAVIORAL

Standard Care

This group will be allocated to standard care and therefore no gamified online exercise training will be provided. They will continue to perform their daily routine/activities including their basic motor skills classes at school and their extracurricular sports and/or cultural activities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Regional Development Fund

OTHER

Sponsor Role collaborator

Gobierno de Navarra Departamento de Salud

UNKNOWN

Sponsor Role collaborator

NavarraBiomed Biomedical Research Center

OTHER

Sponsor Role collaborator

Centro Atención Primaria de Iturrama

UNKNOWN

Sponsor Role collaborator

Universidad Pública de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alicia Mª Alonso Martínez, Ph.D

Role: STUDY_CHAIR

Universidad Pública de Navarra

Locations

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Navarrabiomed, Universidad Pública de Navarra

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

References

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Legarra-Gorgonon G, Garcia-Alonso Y, Ramirez-Velez R, Alonso-Martinez L, Izquierdo M, Alonso-Martinez AM. Assessing basic motor competences, physical fitness, and executive function in 4-5-year-old children: a longitudinal study in a primary care setting. Ital J Pediatr. 2024 May 31;50(1):108. doi: 10.1186/s13052-024-01674-1.

Reference Type DERIVED
PMID: 38816854 (View on PubMed)

Alonso-Martinez AM, Legarra-Gorgonon G, Garcia-Alonso Y, Ramirez-Velez R, Alonso-Martinez L, Erice-Echegaray B, Izquierdo M. Gamified family-based health exercise intervention to improve adherence to 24-h movement behaviors recommendations in children: "3, 2, 1 Move on Study". Trials. 2023 Aug 14;24(1):531. doi: 10.1186/s13063-023-07494-8.

Reference Type DERIVED
PMID: 37580788 (View on PubMed)

Other Identifiers

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PI_2021/111

Identifier Type: -

Identifier Source: org_study_id

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