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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031062
Receipt No. R000035467
Scientific Title The effectiveness of exercise intervention on academic achievement, cognitive function and physical health among children in Mongolia: a cluster RCT study
Date of disclosure of the study information 2018/02/01
Last modified on 2021/10/20

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Basic information
Public title The effectiveness of exercise intervention on academic achievement, cognitive function and physical health among children in Mongolia: a cluster RCT study
Acronym The effectiveness of exercise intervention on academic achievement, cognitive function and physical health among children in Mongolia: a cluster RCT study
Scientific Title The effectiveness of exercise intervention on academic achievement, cognitive function and physical health among children in Mongolia: a cluster RCT study
Scientific Title:Acronym The effectiveness of exercise intervention on academic achievement, cognitive function and physical health among children in Mongolia: a cluster RCT study
Region
Asia(except Japan)

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

Objectives
Narrative objectives1 To investigate the effects of exercise intervention on academic achievement, cognitive function and physical and mental health among children through RCT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Examination marks at national standardized test in May 2018
Key secondary outcomes All of the following will be measured in May 2018
Proportion of obese and over-weight children
Physical fitness (20m shuttle run, side-to-side jumps)
Lifestyle (exercise and sleep)
Psychosocial health (Strengths and Difficulties Questionnaire)
Cognitive function (Flanker test)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Exercise intervention: school based two-miuite high intensity interval training at least three times per week
The intervention will be implemented from February 2018 to May 2018.
Interventions/Control_2 Control
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
10 years-old <=
Age-upper limit
12 years-old >
Gender Male and Female
Key inclusion criteria (1)Children attending at fourth grade of one of the 10 public schools in Sukhbaatar district
(2) Children with written consent from parents or guardians
(3) Children who are able to speak, read or understand Mongolian
Key exclusion criteria (1) Children with comorbidities or contraindication prohibiting participation to exercise program
(2) Children attending at classes with special curriculum such as special classroom
Target sample size 2337

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rintaro Mori
Organization National Center for Child Health and Development
Division name Department of Health Policy
Zip code
Address 2-10-1 Okura,Setagaya-ku,Tokyo
TEL 0334160181
Email rintaromori@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Takehara
Organization National Center for Child Health and Development
Division name Department of Health Policy
Zip code
Address 2-10-1 Okura,Setagaya-ku,Tokyo
TEL 0334160181
Homepage URL
Email takehara-k@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
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 02 Month 01 Day

Related information
URL releasing protocol https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-6986-8
Publication of results Published

Result
URL related to results and publications https://pediatrics.aappublications.org/content/early/2021/10/15/peds.2021-052808
Number of participants that the trial has enrolled 2301
Results Primary outcome
Intervention group members in an urban area showed an 8.36-point improvement (95%CI: 6.06-10.66) in academic scores when compared with the control group, whereas those in a mixed residential area showed a 9.55-point improvement (95%CI: 6.58-12.51).
Secondary outcome
Among intervention group compared to control group, individual subject scores improved, the proportion of overweight/obese participants increased (mixed-residential area only) , and physical fitness improved.
Results date posted
2021 Year 10 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 10 Month 18 Day
Baseline Characteristics There were 969 boys (46.1%) and 909
girls (43.3%) (missing= 223;
10.6%). The mean age was 9.7 years
in both the intervention and control
groups.
Participant flow Of the 2309 fourth-grade children,
none met the exclusion criteria.
Overall, 2301 agreed to participate
(intervention: 1143; control: 1158)
(Table 1). However, 200 were lost to
follow-up because of school transfers
(intervention: 74; control: 126).
Ultimately, 2101 were included in
the primary and secondary outcome
analyses (intervention: 1069; control:
1032).
Adverse events There were no adverse events.
Outcome measures Total score of the national examination
Individual scores of the national examination
The proportion of overweight/obesity
Physical fitness (20m shuttle run, side-to-side test)
Flanker test
Mental health (the Strengths and Difficulties Questionnaire)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 01 Month 12 Day
Date of IRB
2017 Year 09 Month 11 Day
Anticipated trial start date
2018 Year 02 Month 06 Day
Last follow-up date
2018 Year 12 Month 21 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 11 Month 25 Day
Date analysis concluded
2019 Year 11 Month 25 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 30 Day
Last modified on
2021 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035467

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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