UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031062 |
|---|---|
| Receipt number | 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 13:04:32 |
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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
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
takehara-k@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035467
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
