Physical InactivityMove OnNCT05741879
Gamified Family-based Health Exercise Intervention to Improve Adherence to 24-h Movement Behaviors Recommendations in Children.
A study testing Gamified exercise training in people with Physical Inactivity and Obesity, Childhood, run by Universidad Pública de Navarra at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Obesity, Childhood, Sedentary Behavior
- What is being tested?
- Gamified exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Navarrabiomed, Universidad Pública de Navarra
Pamplona, Navarre, 31006
About this study
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".
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.
- Conditions
- Physical Inactivity, Obesity, Childhood, Sedentary Behavior
- Being tested
- Gamified exercise training, Standard Care
- Keywords
- Lack of physical fitness, Low levels of Basic Motor Skills
- Medical subject headings
- Sedentary Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified exercise trainingBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Gamified online exercise in a family environment | Experimental | Strength training Resistance training Flexibility training Basic motor skills training Executive function training Receives: Behavioral: Gamified exercise training |
| Standard care Non-supervised daily routines/activities | Active comparator | Non-supervised daily routines/activities Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 Week, and 24 Week
Secondary outcomes (8)
Changes in body composition.
Body composition measured with bioelectrical impedance (fat mass and body mass).
Measured: Baseline, 12 Week, and 24 Week
Changes in muscle composition.
Muscle composition measured with ultrasound of the thigh/quadriceps/recto femoral.
Measured: Baseline, 12 Week, and 24 Week
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.
Measured: Baseline, 12 Week, and 24 Week
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).
Measured: Baseline, 12 Week, and 24 Week
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.
Measured: Baseline, 12 Week, and 24 Week
Changes in executive function.
Measured with "Early Tools" games (Years Toolbox YET-2017).
Measured: Baseline, 12 Week, and 24 Week
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).
Measured: Baseline, 12 Week, and 24 Week
Changes in quality of life.
Kiddy-KINDL will be used to assess the health-related quality of life in children.
Measured: Baseline, 12 Week, and 24 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Nov 2022
- Primary completion31 May 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, Government of Navarra, NavarraBiomed Biomedical Research Center, Centro Atención Primaria de Iturrama
- Responsible party
- Sponsor
- Investigators
- Alicia Mª Alonso Martínez, Ph.D, Study chair, Universidad Pública de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741879
- Sponsor's protocol ID
- PI_2021/111
- Acronym
- Move On
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38816854Alonso-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.
PubMed 37580788
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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".
- ClinicalTrials.gov ID
- NCT05741879
- Acronym / sponsor ID
- Move On / PI_2021/111
- Conditions
- Physical Inactivity, Obesity, Childhood, Sedentary Behavior
- Keywords
- Lack of physical fitness, Low levels of Basic Motor Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Collaborators
- European Regional Development Fund, Government of Navarra, NavarraBiomed Biomedical Research Center, Centro Atención Primaria de Iturrama
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamified online exercise in a family environment | Experimental | Behavioral: Gamified exercise trainingStrength training Resistance training Flexibility training Basic motor skills training Executive function training |
| Standard care Non-supervised daily routines/activities | Active comparator | Behavioral: Standard CareNon-supervised daily routines/activities |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified exercise trainingParticipants 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). | Behavioural | Gamified online exercise in a family environment |
| Standard CareThis 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. | Behavioural | Standard care Non-supervised daily routines/activities |
Primary outcome
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.
8 secondary outcomes
Changes in body composition.
Time frame: Baseline, 12 Week, and 24 Week
Changes in muscle composition.
Time frame: Baseline, 12 Week, and 24 Week
Changes in health-related physical fitness.
Time frame: Baseline, 12 Week, and 24 Week
Changes in Basic Motor Skills.
Time frame: Baseline, 12 Week, and 24 Week
Changes in 24-h movement behaviors (self-reported).
Time frame: Baseline, 12 Week, and 24 Week
Changes in executive function.
Time frame: Baseline, 12 Week, and 24 Week
Changes in Child Self-Regulation & Behavior.
Time frame: Baseline, 12 Week, and 24 Week
Changes in quality of life.
Time frame: Baseline, 12 Week, and 24 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 38816854Legarra-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.
- Derived from this study: PubMed 37580788Alonso-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Mª Alonso Martínez, Ph.D study chair
Universidad Pública de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified exercise training in people with Physical Inactivity and Obesity, Childhood, run by Universidad Pública de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 24-h movement behaviors (accelerometers) sedentary time. (time frame: Baseline, 12 Week, and 24 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05741879, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.