UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness verification of soccer kids program for infants
Acronym	Effectiveness verification of soccer kids program for infants
Scientific Title	Effectiveness verification of soccer kids program for infants
Scientific Title:Acronym	Effectiveness verification of soccer kids program for infants
Region	Japan

Condition
Condition	Child
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to measure the effect of soccer kids program by measuring physical activity and steps.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of physical activity and steps for 3 days including soccer kids program
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	One time, soccer kids program of about 60 minutes
Interventions/Control_2
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	Those who have obtained parental consent and have not refused to attach the measuring device
Key exclusion criteria	Those who did not get parental consent and have refused to wear the measuring device
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Hiroki
Organization	Juntendo University
Division name	Faculty of Health and Sports Science
Zip code	270-1695
Address	1-1 Hiraka-gakuendai, Inzai - shi, Chiba
TEL	0476-98-1001
Email	hirokinwater@gmail.com

Public contact
Name of contact person	1st name Takeshi Middle name Last name Hiroki
Organization	Juntendo University
Division name	Faculty of Health and Sports Science
Zip code	244-0816
Address	769-24 Kamikuratacho, Totsuka-ku, Yokohama, Kanagawa
TEL	045-864-4990
Homepage URL
Email	hirokinwater@gmail.com

Sponsor
Institute	Juntendo University Faculty of Health and Sports Science
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Juntendo University
Address	1-1 Hiraka-gakuendai, Inzai - shi, Chiba
Tel	0476-98-1001
Email	ko-suzuki@juntendo.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	2020 Year 04 Month 24 Day

Related information
URL releasing protocol	https://www.shobix.co.jp/jssf/tempfiles/journal/2021/211.pdf
Publication of results	Published

Result
URL related to results and publications	https://www.shobix.co.jp/jssf/tempfiles/journal/2021/211.pdf
Number of participants that the trial has enrolled	100
Results	Our findings suggest that the soccer kids' program has an effect on increasing physical activity a day in nursery school children, and the program may also increase physical activity of those who are not active in the outdoor activity program.
Results date posted	2022 Year 01 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The subjects were 38 children in the 5-year-old class and 29 children in the 4-year-old class in nursery schools.
Participant flow	Physical activity (moderate-to-vigorous physical activity: MVPA and step counts) was measured by using a uniaxial accelerometer (Lifecorder EX; Suzuken Co. Ltd, Nagoya, Japan). The physical activity measurement was performed for 3 days (from 9am to 12pm) of regular activity program day, outdoor activity program day, and soccer program day.
Adverse events	The purpose of this study was to clarify physical activity characteristics of the soccer kids program (Japan Football Association recommended program) by comparing with typical daily activities in nursery school children. In particular, we focused on the differences among individuals and nursery schools.
Outcome measures	The physical activity(MVPA(min) and Steps) Calculated CV
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 07 Month 01 Day
Date of IRB	2019 Year 05 Month 27 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 23 Day
Last modified on	2022 Year 01 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042537