UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032614
Receipt number 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 16:18:37

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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 or person

Institute

Hokkaido University of Education

Institute

Department

Personal name



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

Value
https://center6.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