Skip to content

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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05741879
Acronym
Move On
Enrollment
100
Registered
2023-02-23
Start date
2022-11-01
Completion date
2023-12-31
Last updated
2025-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood, Physical Inactivity, Sedentary Behavior

Keywords

Lack of physical fitness, Low levels of Basic Motor Skills

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.

Interventions

BEHAVIORALGamified 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).

BEHAVIORALStandard 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.

Sponsors

European Regional Development Fund
CollaboratorOTHER
Gobierno de Navarra Departamento de Salud
CollaboratorUNKNOWN
NavarraBiomed Biomedical Research Center
CollaboratorOTHER
Centro Atención Primaria de Iturrama
CollaboratorUNKNOWN
Universidad Pública de Navarra
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in 24-h movement behaviors (accelerometers) sedentary time.Baseline, 12 Week, and 24 WeekDuring 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

MeasureTime frameDescription
Changes in muscle composition.Baseline, 12 Week, and 24 WeekMuscle composition measured with ultrasound of the thigh/quadriceps/recto femoral.
Changes in health-related physical fitness.Baseline, 12 Week, and 24 WeekHealth-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.
Changes in Basic Motor Skills.Baseline, 12 Week, and 24 WeekMeasured 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).
Changes in body composition.Baseline, 12 Week, and 24 WeekBody composition measured with bioelectrical impedance (fat mass and body mass).
Changes in executive function.Baseline, 12 Week, and 24 WeekMeasured with Early Tools games (Years Toolbox YET-2017).
Changes in Child Self-Regulation & Behavior.Baseline, 12 Week, and 24 WeekMeasured 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).
Changes in quality of life.Baseline, 12 Week, and 24 WeekKiddy-KINDL will be used to assess the health-related quality of life in children.
Changes in 24-h movement behaviors (self-reported).Baseline, 12 Week, and 24 WeekSelf-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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026