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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034992
Receipt No. 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 2019/05/28

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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
Email 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
Email yukaa@yamanashi.ac.jp

Sponsor
Institute University of Yamanashi, Department of Health sciences, Faculty of Medicine
Institute
Department

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
Email 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
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 No longer recruiting
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
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039902

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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