UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050736 |
|---|---|
| Receipt number | R000057403 |
| Scientific Title | Effects of online distribution of health-related video content on Internet dependence, physical and mental health, and lifestyle habits among college students. |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/04/07 01:07:36 |
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Basic information
Public title
Effects of online distribution of health-related video content on Internet dependence, physical and mental health, and lifestyle habits among college students.
Acronym
Effects of online video content distribution targeting college students on Internet dependence and health.
Scientific Title
Effects of online distribution of health-related video content on Internet dependence, physical and mental health, and lifestyle habits among college students.
Scientific Title:Acronym
Effects of online video content distribution targeting college students on Internet dependence and health.
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the effects of distributing video content on health on Internet dependence, physical activity, sedentary time, mental health, and lifestyle habits among college students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Internet Dependence
Key secondary outcomes
Screen time
physical activity (IPAQ-SF, number of steps)
Mental health (WHO-5, K6)
Health literacy (HLS-EU-Q47)
Lifestyle habits (PSQI, breakfast or no breakfast)
Frequency of watching videos, number of times performing video exercises
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The e-learning group will receive and watch 8 weekly e-learning videos (8 videos for 8 weeks), each lasting about 5 minutes, on health-related topics.
After 8 weeks, a questionnaire survey will be administered to determine whether the participants have decreased their dependence on the Internet, increased their physical activity, and improved their quality of life, subjective well-being, and health literacy.
Interventions/Control_2
The e-learning and exercise groups will receive and watch a 5-minute e-learning video on health and a 20-minute exercise video every week (for 8 weeks, 8 videos in total). 8 weeks later, a questionnaire will be administered to determine whether they have decreased Internet dependence, increased physical activity, improved quality of life, subjective well-being, and health literacy. quality of life, subjective sense of well-being, and health literacy.
Interventions/Control_3
Establish a control group.
A group that does not fall under the e-learning group or the e-learning and exercise group and does not watch or conduct any health-related video content.
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) University students who are at least 18 years old and less than 25 years old at the time of obtaining consent.
(2) Owners of smartphones, PCs, or tablets with access to an Internet environment
(3) Persons who are able to consent to participate in this study.
Key exclusion criteria
(1) Persons who have a disease that prohibits exercise or have a history of such a disease.
(2) Those who do not own electronic devices such as smartphones or tablets.
(3) Those who are in a vulnerable position as a research subject, such as the relationship between the principal investigator and the research subject as a faculty member and a student, and the student is attending a lecture given by the principal investigator or the research subject
(4) Other persons deemed inappropriate by the principal investigator or research assistants.
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Urabe |
Organization
Graduate School of Biomedical and Health Sciences
Hiroshima University
Division name
Laboratory of Sports Rehabilitation Science
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
090-6611-4702
hinataesaki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | nanako |
| Middle name | |
| Last name | murata |
Organization
Graduate School of Biomedical and Health Sciences Hiroshima University
Division name
Laboratory of Sports Rehabilitation Science
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
090-6611-4702
Homepage URL
nanako-murata@hiroshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Biomedical and Health Sciences Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-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
| 2023 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057403
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