UMIN-CTR Clinical Trial

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
Email	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
Email	kaneita.yoshitaka@gmail.com

Sponsor
Institute	Nihon University School of Medicine, Division of Public Health, Department of Social Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051466