Clinical trial NCT05741879: Gamified Family-based Health Exercise Intervention to Improve Adherence to 24-h Movement Behaviors Recommendations in Children.
Official title: 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".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Inactivity
Obesity, Childhood
Sedentary Behavior
Keywords: Lack of physical fitness
Low levels of Basic Motor Skills
Lead sponsor: Universidad Pública de Navarra
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
name: Gobierno de Navarra Departamento de Salud
name: NavarraBiomed Biomedical Research Center
name: Centro Atención Primaria de Iturrama
First posted: 2023-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Changes in 24-h movement behaviors (accelerometers) sedentary time.
timeFrame: Baseline, 12 Week, and 24 Week
Secondary outcomes:
measure: Changes in body composition.
timeFrame: Baseline, 12 Week, and 24 Week
measure: Changes in muscle composition.
timeFrame: Baseline, 12 Week, and 24 Week
measure: Changes in health-related physical fitness.
timeFrame: Baseline, 12 Week, and 24 Week
measure: Changes in Basic Motor Skills.
timeFrame: Baseline, 12 Week, and 24 Week
measure: Changes in 24-h movement behaviors (self-reported).
timeFrame: Baseline, 12 Week, and 24 Week
measure: Changes in executive function.
timeFrame: Baseline, 12 Week, and 24 Week
measure: Changes in Child Self-Regulation & Behavior.
timeFrame: Baseline, 12 Week, and 24 Week
measure: Changes in quality of life.
timeFrame: Baseline, 12 Week, and 24 Week
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Navarrabiomed, Universidad Pública de Navarra
state: Navarra
Study officials:
affiliation: Universidad Pública de Navarra
name: Alicia Mª Alonso Martínez, Ph.D
role: STUDY_CHAIR
References: