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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051466