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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032614
Receipt No. R000037188
Scientific Title Prospective study for associations between cognitive development, physical fitness, and health behaviors in children and adolescents in Hokkaido, Japan.
Date of disclosure of the study information 2018/06/01
Last modified on 2021/06/09

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Basic information
Public title Prospective study for associations between cognitive development, physical fitness, and health behaviors in children and adolescents in Hokkaido, Japan.
Acronym Brain Up by Sports and Health Improvement for children in HokkaiDo (BUSHI-DO)
Scientific Title Prospective study for associations between cognitive development, physical fitness, and health behaviors in children and adolescents in Hokkaido, Japan.
Scientific Title:Acronym Brain Up by Sports and Health Improvement for children in HokkaiDo (BUSHI-DO)
Region
Japan

Condition
Condition Executive function
Physical fitness
Classification by specialty
Not applicable Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this prospective study was to determine the influences of physical fitness, weight status (obesity/underweight), and exercise habits on the developmental growth of cognitive function of Japanese elementary and junior high school students and to elucidate the implications of fitness/exercise habits in the developmental growth of cognitive function during childhood.
Basic objectives2 Others
Basic objectives -Others 1) Growth trends of cognitive function
2) Relationships of cognitive function with physical fitness, weight status, and exercise habits in children
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Higher order cognitive function (executive function): inhibitory control and working memory
Key secondary outcomes Physical fitness
Weight status (obesity and underweight)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
8 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria 1) Parental consent
2) Third to 6th grade elementary school and junior high school children
3) Capable of performing exercises
4) Absence of school-identified learning disability and ADHD
Key exclusion criteria 1) Non-consent of guardian
2) Above or below the age range
3) Any physical disability that prohibits exercise
4) School-identified learning disability and ADHD
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriteru Morita
Organization Hokkaido University of Education, Iwamizawa
Division name Dept. Art and Sport Cultural Studies
Zip code
Address 2-34-1 Midorigaoka, Iwamizawa, Hokkaido, Japan
TEL 0126-32-0250
Email morita.noriteru@i.hokkyodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriteru Morita
Organization Hokkaido University of Education
Division name Dept. Art and Sport Cultural Studies
Zip code
Address 2-34-1 Midorigaoka, Iwamizawa, Hokkaido
TEL 0126-32-0250
Homepage URL
Email morita.noriteru@i.hokkyodai.ac.jp

Sponsor
Institute Hokkaido University of Education
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 06 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
2017 Year 05 Month 26 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This longitudinal study evaluates associations of growth trends of physical fitness and weight status with the developmental growth of executive function of Japanese elementary and junior high school students. This study is ongoing and will be completed in March 2021.

Management information
Registered date
2018 Year 05 Month 16 Day
Last modified on
2021 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037188

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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