UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045062 |
|---|---|
| Receipt number | R000051466 |
| Scientific Title | Examination of health education program for Internet/smartphone addiction among Japanese adolescents: a cluster randomized controlled trial |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/08/15 16:51:01 |
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Basic information
Public title
Examination of health education program for Internet/smartphone addiction
Acronym
Examination of health education program for Internet/smartphone addiction
Scientific Title
Examination of health education program for Internet/smartphone addiction among Japanese adolescents: a cluster randomized controlled trial
Scientific Title:Acronym
Examination of health education program for Internet/smartphone addiction among Japanese adolescents: a cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Well-adolescents
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey adolescent internet/smartphone education programs improve health promotion, including internet/ smartphone addiction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Internet / smartphone addiction scale scores
Key secondary outcomes
Change in health behavior change
Change in Happiness scale
Change in sleep-related indicators
Change in lifestyle behavior
Change in headache assessment score
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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: 10 educational programs
Interventions/Control_2
Control group: No program
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Adolescents showing consent to attend this project
2. Adolescents' age: ranged from 15 to 18
Key exclusion criteria
Adolescents who were judged as inappropriate subjects by researcher
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kaneita |
Organization
Nihon University School of Medicine
Division name
Division of Public Health, Department of Social Medicine
Zip code
1738610
Address
30-1,Oyaguchi,kamimati,Itabasi-ku,Tokyo
TEL
+81339728111
kaneita.yoshitaka@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kaneita |
Organization
Nihon University School of Medicine
Division name
Division of Public Health, Department of Social Medicine
Zip code
1738610
Address
30-1,Oyaguchi,kamimati,Itabasi-ku,Tokyo
TEL
+81339728111
Homepage URL
kaneita.yoshitaka@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine, Division of Public Health, Department of Social Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Scienceand Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine
Address
30-1,Oyaguchi,kamimati,Itabasi-ku,Tokyo
Tel
+81339728111
med.kenjim@nihon-u.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
| 2022 | Year | 03 | Month | 31 | 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
5229
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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 04 | Day |
Last modified on
| 2022 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051466
