NCT05978869

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 31, 2023

Last Update Submit

July 31, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    week 12

Secondary Outcomes (1)

  • Satisfaction levels

    Week 12

Study Arms (2)

physical fitness training

EXPERIMENTAL

The training group received physical fitness training for 12 weeks

Other: physical fitness training

No training group

NO INTERVENTION

The no training group did not receive any training program

Interventions

Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team.

physical fitness training

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • school children in 5th grade

You may not qualify if:

  • physical deformity, mental disability, limited higher density physical activity such as asthma, cardiovascular disease, and bone fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chi-Jane Wang

Tainan, 701, Taiwan

Location

Study Officials

  • Chi-Jane Wang, Ph.D.

    Department of Nursing, College of Medicine, National Cheng Kung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 7, 2023

Study Start

February 14, 2018

Primary Completion

December 15, 2018

Study Completion

December 15, 2018

Last Updated

August 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations