- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05978869
Gamified Fitness Training to Promote Children's Physical Activity
July 31, 2023 updated by: Chi-Jane Wang
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
91
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tainan, Taiwan, 701
- Chi-Jane Wang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- school children in 5th grade
Exclusion Criteria:
- physical deformity, mental disability, limited higher density physical activity such as asthma, cardiovascular disease, and bone fracture.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: physical fitness training
The training group received physical fitness training for 12 weeks
|
Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team.
|
|
No Intervention: No training group
The no training group did not receive any training program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
week 0
|
|
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.
|
week 0
|
|
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.
|
week 6
|
|
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.
|
week 12
|
|
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.
|
week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction levels
Time Frame: Week 12
|
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.
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chi-Jane Wang, Ph.D., Department of Nursing, College of Medicine, National Cheng Kung University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2018
Primary Completion (Actual)
December 15, 2018
Study Completion (Actual)
December 15, 2018
Study Registration Dates
First Submitted
July 31, 2023
First Submitted That Met QC Criteria
July 31, 2023
First Posted (Actual)
August 7, 2023
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
July 31, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- A-ER-106-441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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