UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034992 |
|---|---|
| Receipt number | R000039902 |
| Scientific Title | Effects of school-based intervention to promote short-time exercise on bone density, physical activity, and psychosocial factors of school children: a cluster randomized controlled trial |
| Date of disclosure of the study information | 2018/11/26 |
| Last modified on | 2022/12/18 13:49:04 |
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Basic information
Public title
Effects of school-based intervention to promote short-time exercise on bone density, physical activity, and psychosocial factors of school children: a cluster randomized controlled trial
Acronym
Effects of school-based intervention to promote short-time exercise on bone density, physical activity, and psychosocial factors of school children: a cluster randomized controlled trial
Scientific Title
Effects of school-based intervention to promote short-time exercise on bone density, physical activity, and psychosocial factors of school children: a cluster randomized controlled trial
Scientific Title:Acronym
Effects of school-based intervention to promote short-time exercise on bone density, physical activity, and psychosocial factors of school children: a cluster randomized controlled trial
Region
| Japan |
Condition
Condition
physical inactivity, osteoporosis
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of school-based intervention to promote short-time physical activity (playing) for increasing bone density, physical activity, and improveing psychosocial factors such as non-cognitive skills and mental health in elementary school children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in physical activity level from baseline to 1-year follw-up (6-month post-intervention follw-up)
Changes in quantitative ultrasound parameters (Stiffness index, SOS (speed of sound),BUA (broadband ultrasound attenuation) in post-intervention
Key secondary outcomes
Change in physical activity level in post-intervention
Changes in steps, sedentary behavior, proportion of engage in the recommended hour of physical activity per day, and psycho-social variables (e.g. non-cognitive skills, mental health) in post- and 6-month post-intervention
Changes in the above variables in motivational readiness in exercise behavior
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group:
Wearing a wristband type activity tracker 4 times a year
School-based intervention to encourage short-time (about 10 second at one time) physical activity (playing) for 6 months.
Interventions/Control_2
Control group:
Wearing a wristband type activity tracker 4 times a year
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
| 9 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Fourth- and fifth grade children belonging to elementary school in the area
Children without restriction of physical activity
Key exclusion criteria
Children who have depression symptom
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Zentaro |
| Middle name | |
| Last name | Yamagata |
Organization
University of Yamanashi
Division name
Department of Health sciences, Faculty of Medicine
Zip code
4093821
Address
1110, Shimokato, Chuo, Yamanashi, Japan
TEL
055-273-9564
zenymgt@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Akiyama |
Organization
University of Yamanashi
Division name
Department of Health sciences, Faculty of Medicine
Zip code
4093821
Address
1110, Shimokato, Chuo, Yamanashi, Japan
TEL
055-273-9566
Homepage URL
yukaa@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi, Department of Health sciences, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato University
Name of secondary funder(s)
Sasakawa Sports Foundation
Japan Osteoporosis Foundation
Meiji Yasuda Life Foundation of Health and Welfare
IRB Contact (For public release)
Organization
Ethics committee of the Faculty of Medicine, University of Yamanashi
Address
1110, Shimokato, Chuo, Yamanashi
Tel
055-273-9065
ayukari@yamanashi.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
| 2018 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/1660-4601/18/7/3351
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
265
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because it has been taking more time than planned to process the data acquired by the wearable device.
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039902
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/06/07 | ijerph-18-03351.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
