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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044054
Receipt No. 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 2021/04/27

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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
Email 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
Email kkeisuke@meijo-u.ac.jp

Sponsor
Institute Laboratory of Sports Science, Department of Liberal Arts, Faculty of Agriculture, Meijo University
Institute
Department

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
Email 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 Preinitiation
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
2021 Year 11 Month 05 Day
Date of closure to data entry
2021 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 01 Month 31 Day
Date analysis concluded
2022 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2021 Year 04 Month 27 Day
Last modified on
2021 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050298

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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