UMIN-CTR Clinical Trial

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