Physical Activity LevelsNCT05978869
Gamified Fitness Training to Promote Children's Physical Activity
A study testing physical fitness training in people with Physical Activity Levels, run by Chi-Jane Wang at 1 site in Taiwan.
Trial summary
The study aimed to introduce gamified physical fitness training in health education with the goal of enhancing physical activity levels and assessing its feasibility within a small-scale context involving 11-12-year-old children. Read more about this study
- Who is it for?
- Ages 11 to 12 years
- Conditions the study is for
- Physical Activity Levels
- What is being tested?
- physical fitness training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Feb 2018to 15 Dec 2018
- 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 11 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- school children in 5th grade
Who cannot join
- physical deformity, mental disability, limited higher density physical activity such as asthma, cardiovascular disease, and bone fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Gamified Fitness Training Integrated Into Health Education to Promote Children's Physical Activity
The study aimed to introduce gamified physical fitness training in health education with the goal of enhancing physical activity levels and assessing its feasibility within a small-scale context involving 11-12-year-old children.
Read the detailed description
A cluster experimental design was conducted in a small-scale context of school children. Participants were recruited by inviting two elementary schools located in the same district area for testing the physical fitness training effects. Two schools were randomly assigned to either the training group (TG; n = 47) receiving physical fitness training or the control group (CG; n = 44) without the training. Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team from the TG school. PA outcome indicators were assessed using AI-wireless sensors attached to participants' wrists over 12 weeks. Participants' satisfaction was used to assess the feasibility of implementing gamified physical fitness training in health education classes. Data collection occurred during school days for one week at three-time points: the first week (T1), 6th week (T2), and the 12th week (T3). Generalized estimating equation statistics were used to assess the program effects.
- Conditions
- Physical Activity Levels
- Being tested
- physical fitness training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical fitness trainingOther
Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team.
| Study group | Role | What they receive |
|---|---|---|
| physical fitness training | Experimental | The training group received physical fitness training for 12 weeks Receives: Other: physical fitness training |
| No training group | No intervention | The no training group did not receive any training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity levels
PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.
Measured: week 0
Learning Self-Efficacy
Learning Self-Efficacy Scale (LSES) contains 18 items scored on a 5-point Likert scale with 4 items reversely scored. The total score of LSES ranges from -6 to 66, with higher scores reflecting higher LSE.
Measured: week 0
physical activity levels
PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.
Measured: week 6
physical activity levels
PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.
Measured: week 12
Learning Self-Efficacy
Learning Self-Efficacy Scale (LSES) contains 18 items scored on a 5-point Likert scale with 4 items reversely scored. The total score of LSES ranges from -6 to 66, with higher scores reflecting higher LSE.
Measured: week 12
Secondary outcomes (1)
Satisfaction levels
For the satisfaction of the PA program, the evaluation was conducted at the 12-week, encompassing five aspects: the integration of physical training into the HE classes, the content of the physical training, the application of gamification strategies in training, the active play during class breaks, and the effectiveness of GHPT in improving PA. Responses to levels of satisfaction with the training program were assessed across five categories: very satisfied, satisfied, OK, dissatisfied, and extremely dissatisfied.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start14 Feb 2018
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Activity LevelsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chi-Jane Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chi-Jane Wang, National Cheng-Kung University Hospital
- Investigators
- Chi-Jane Wang, Ph.D., Principal investigator, Department of Nursing, College of Medicine, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978869
- Sponsor's protocol ID
- A-ER-106-441
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Gamified Fitness Training Integrated Into Health Education to Promote Children's Physical Activity
- ClinicalTrials.gov ID
- NCT05978869
- Acronym / sponsor ID
- A-ER-106-441
- Conditions
- Physical Activity Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Chi-Jane WangUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 7 Aug 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.
The study aimed to introduce gamified physical fitness training in health education with the goal of enhancing physical activity levels and assessing its feasibility within a small-scale context involving 11-12-year-old children.
Detailed description
A cluster experimental design was conducted in a small-scale context of school children. Participants were recruited by inviting two elementary schools located in the same district area for testing the physical fitness training effects. Two schools were randomly assigned to either the training group (TG; n = 47) receiving physical fitness training or the control group (CG; n = 44) without the training. Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team from the TG school. PA outcome indicators were assessed using AI-wireless sensors attached to participants' wrists over 12 weeks. Participants' satisfaction was used to assess the feasibility of implementing gamified physical fitness training in health education classes. Data collection occurred during school days for one week at three-time points: the first week (T1), 6th week (T2), and the 12th week (T3). Generalized estimating equation statistics were used to assess the program effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical fitness training | Experimental | Other: physical fitness trainingThe training group received physical fitness training for 12 weeks |
| No training group | No intervention | –The no training group did not receive any training program |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- school children in 5th grade
Key exclusion criteria (1 listed)
- physical deformity, mental disability, limited higher density physical activity such as asthma, cardiovascular disease, and bone fracture.
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 |
|---|---|---|
| physical fitness trainingThrough a three-step process, gamified physical fitness training was developed by a multidisciplinary team. | Other | physical fitness training |
Primary outcome
physical activity levels
Time frame: week 0
PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.
Learning Self-Efficacy
Time frame: week 0
Learning Self-Efficacy Scale (LSES) contains 18 items scored on a 5-point Likert scale with 4 items reversely scored. The total score of LSES ranges from -6 to 66, with higher scores reflecting higher LSE.
physical activity levels
Time frame: week 6
PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.
physical activity levels
Time frame: week 12
PA levels were measured in minutes spent on daily steps, total physical activity (TPA), light physical activity (LPA), moderate-to-vigorous physical activity (MVPA), and daily step counts using AI-wireless sensors attached to participants' wrists.
Learning Self-Efficacy
Time frame: week 12
Learning Self-Efficacy Scale (LSES) contains 18 items scored on a 5-point Likert scale with 4 items reversely scored. The total score of LSES ranges from -6 to 66, with higher scores reflecting higher LSE.
1 secondary outcome
Satisfaction levels
Time frame: Week 12
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 7 Aug 2023.
- 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.
Chi-Jane Wang, Ph.D. principal investigator
Department of Nursing, College of Medicine, National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical fitness training in people with Physical Activity Levels, run by Chi-Jane Wang at 1 site in Taiwan.
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 1 inclusion and 1 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 7 Aug 2023. 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 Taiwan. 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?
physical activity levels (time frame: week 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2023.