UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044480
Receipt number R000050816
Scientific Title A prospective study for associations of physical fitness and health behaviors to cognitive function and academic performance in children and adolescents in Hokkaido, Japan.
Date of disclosure of the study information 2021/06/21
Last modified on 2021/06/09 16:20:22

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Basic information

Public title

A prospective study for associations of physical fitness and health behaviors to cognitive function and academic performance in children and adolescents in Hokkaido, Japan.

Acronym

Brain Up by Sports and Health Improvement for children in HokkaiDo 2 (BUSHIDO2)

Scientific Title

A prospective study for associations of physical fitness and health behaviors to cognitive function and academic performance in children and adolescents in Hokkaido, Japan.

Scientific Title:Acronym

Brain Up by Sports and Health Improvement for children in HokkaiDo 2 (BUSHIDO2)

Region

Japan


Condition

Condition

Cognitive function
Academic performance
Sociality
Physical fitness
Body weight status

Classification by specialty

Not applicable Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this prospective study is to determine the influences of physical fitness, weight status (obesity/underweight), social and daily behaviors on the cognitive function and academic performance in Japanese elementary school children.

Basic objectives2

Others

Basic objectives -Others

1. To determine growth trends of cognitive function in children of Hokkaido, Japan.
2. To investigate associations relationships of physical fitness, weight status, and social and daily behaviors to cognitive function and academic performance in children.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Cognitive function
Academic performance

Key secondary outcomes

Social behaviors


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/guardian consent
2. 3rd to 6th grades
3. Capable of performing exercise
4. Absence of neurodevelopmental disorders

Key exclusion criteria

1. Non-consent of parent/guardian
2. Above or below age range
3. Any physical disability that prohibits exercise
4. Neurodevelopmental disorders

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Noriteru
Middle name
Last name Morita

Organization

Hokkaido University of Education

Division name

Dept. Art and Sport Cultural Studies

Zip code

068-8642

Address

2-34-1 Midorigaoka, Iwamizawa, Hokkaido

TEL

0126-32-0393

Email

morita.noriteru@i.hokkyodai.ac.jp


Public contact

Name of contact person

1st name Noriteru
Middle name
Last name Morita

Organization

Hokkaido University of Education

Division name

Dept. Art and Sport Cultural Studies

Zip code

068-8642

Address

2-34-1 Midorigaoka, Iwamizawa, Hokkaido

TEL

0126-32-0393

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



Other related organizations

Co-sponsor

Chukyo University
Kobe University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University of Education

Address

5-3 Ainosato, Kita-ku, Sapporo, Hokkaido

Tel

011-778-0649

Email

s-kenkyu@j.hokkyodai.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 06 Month 21 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

2020 Year 08 Month 19 Day

Date of IRB

2020 Year 08 Month 19 Day

Anticipated trial start date

2020 Year 08 Month 19 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The aim of this prospective study is to determine the influences of physical fitness, weight status (obesity/underweight), social and daily behaviors on cognitive function, and academic performance in Japanese elementary school children.

Main outcome: Cognitive function and Academic performance
Measurement variables: Physical fitness, body weight status, social behaviors, lifestyle behaviors.
These variables are measured once a school year.


Management information

Registered date

2021 Year 06 Month 09 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=R000050816


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name