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

Physical Inactivity Clinical Trial

— Move On  

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".

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05741879
• Other study ID #: PI_2021/111
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Universidad Pública de Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity
• Physical Inactivity
• Sedentary Behavior

Intervention

Behavioral:
• 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).
• 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.

Locations

Country	Name	City	State
Spain	Navarrabiomed, Universidad Pública de Navarra	Pamplona	Navarra

Sponsors (5)

Lead Sponsor	Collaborator
Universidad Pública de Navarra	Centro Atención Primaria de Iturrama, European Regional Development Fund, Gobierno de Navarra Departamento de Salud, NAVARRABIOMED

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in 24-h movement behaviors (accelerometers) sedentary time.	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.	Baseline, 12 Week, and 24 Week
Secondary	Changes in body composition.	Body composition measured with bioelectrical impedance (fat mass and body mass).	Baseline, 12 Week, and 24 Week
Secondary	Changes in muscle composition.	Muscle composition measured with ultrasound of the thigh/quadriceps/recto femoral.	Baseline, 12 Week, and 24 Week
Secondary	Changes in health-related physical fitness.	Health-related physical fitness measured, among other tests from the PREFIT battery, with the 20-meter shuttle run test, the handgrip test and the 4x10 speed agility test.	Baseline, 12 Week, and 24 Week
Secondary	Changes in Basic Motor Skills.	Measured with the MOBAK-KG Battery with tests such as the long jump or balance over an inverted beam. MOBAK-KG sum score ranging from 0 (lowest basic motor competencies) to 16 points (highest basic motor competencies).	Baseline, 12 Week, and 24 Week
Secondary	Changes in 24-h movement behaviors (self-reported).	Self-report of physical activity levels and sedentary behaviors in youth will assessed by the Youth Activity Profile - Spain. In this questionnaire, a rating scale is used with a score from 1 to 5 in which, in the first two sections, "1" indicates low intensity and frequency of physical activity and "5" indicates high intensity and frequency of physical activity; while, in the third section, "1" indicates a low amount of sedentary behaviors and "5" an excess of them.	Baseline, 12 Week, and 24 Week
Secondary	Changes in executive function.	Measured with "Early Tools" games (Years Toolbox YET-2017).	Baseline, 12 Week, and 24 Week
Secondary	Changes in Child Self-Regulation & Behavior.	Measured with CSBQ (Child Self-Regulation & Behavior Questionnaire). Parents will be asked to think about their child's behavior during the past 6 months, and to choose whether each statement was: Not true (1), Somewhat true (2), Certainly true (3), or Can't say (4).	Baseline, 12 Week, and 24 Week
Secondary	Changes in quality of life.	Kiddy-KINDL will be used to assess the health-related quality of life in children.	Baseline, 12 Week, and 24 Week