UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044054 |
|---|---|
| Receipt number | R000050298 |
| Scientific Title | Effectiveness of Day-to-day Desk-top Calendar to Promote Parent-child Physical Play on Motor Skill Development in Early Childhood: A Randomized Controlled Pilot Study |
| Date of disclosure of the study information | 2021/04/27 |
| Last modified on | 2022/10/28 09:13:19 |
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Basic information
Public title
Effectiveness Trial of Day-to-day Desk-top Calendar to Promote Parent-child Physical Play on Motor Skill Development in Early Childhood
Acronym
Effectiveness Trial of Day-to-day Desk-top Parent-child Physical Play Calendar
Scientific Title
Effectiveness of Day-to-day Desk-top Calendar to Promote Parent-child Physical Play on Motor Skill Development in Early Childhood: A Randomized Controlled Pilot Study
Scientific Title:Acronym
Effectiveness Trial of Day-to-day Desk-top Parent-child Physical Play Calendar
Region
| Japan |
Condition
Condition
inadequate development of motor skills
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility, acceptability, and preliminary effectiveness of an intervention using a day-to-day desk-top calendar promoting parent-child physical play.
Basic objectives2
Others
Basic objectives -Others
Feasibility, acceptability, and effectiveness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
TGMD-3 (Baseline, 5 months later)
Key secondary outcomes
Children's positive attitude toward exercise
Frequency of parent-child physical play
Confidence in parent-child physical play
Knowledge of parent-child physical play methods
Frequency of turning the calendar
Frequency of practicing parent-child physical play on the calendar
The joy of parent-child physical play on the calendar
The burden of parent-child physical play on the calendar
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group:
Distribute day-to-day parent-child physical play calendar (have child turn it over every day, place it in the living room or other places where they can be seen)
Interventions/Control_2
Control group:
None (usual childcare)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 4 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The second and third year of preschool children without restriction of physical activity
Key exclusion criteria
none
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Komura |
Organization
Meijo University
Division name
Laboratory of Sports Science, Department of Liberal Arts, Faculty of Agriculture
Zip code
468-8502
Address
1-501, Shiogamaguti, Tempaku, Nagoya
TEL
052-838-2468ext.6141
kkeisuke@meijo-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Komura |
Organization
Meijo University
Division name
Laboratory of Sports Science, Department of Liberal Arts, Faculty of Agriculture
Zip code
468-8502
Address
1-501, Shiogamaguti, Tempaku, Nagoya
TEL
052-838-2468ext.6141
Homepage URL
kkeisuke@meijo-u.ac.jp
Sponsor or person
Institute
Laboratory of Sports Science, Department of Liberal Arts, Faculty of Agriculture, Meijo University
Institute
Department
Personal name
Funding Source
Organization
Meijo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1) Gifu Shotoku Gakuen University Junior College
2) Chubu Gakuin University Junior College
3) Mukaijima Kindergarten
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics review committee of Meijo University
Address
1-501, Shiogamaguti, Tempaku, Nagoya
Tel
052-838-2034
rinri@ccml.meijo-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 05 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 27 | Day |
Last modified on
| 2022 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050298
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
