UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059454 |
|---|---|
| Receipt number | R000068004 |
| Scientific Title | The effect of participating in health education programs using mobile health devices on the mental health of college students |
| Date of disclosure of the study information | 2025/10/19 |
| Last modified on | 2025/10/19 16:30:39 |
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Basic information
Public title
The effect of participating in health education programs using mobile health devices on the mental health of college students
Acronym
The effect of participating in health education programs using mobile health devices on the mental health of college students
Scientific Title
The effect of participating in health education programs using mobile health devices on the mental health of college students
Scientific Title:Acronym
The effect of participating in health education programs using mobile health devices on the mental health of college students
Region
| Japan |
Condition
Condition
mental health
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the impact of a health education program using mobile health devices on the mental health of college students
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of Mood States2 short version
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use a mHealth device for a month
Complete a daily log for a month
Personalized health guidance once a week, based on data recorded in the lifestyle log and mHealth device.
Interventions/Control_2
Use a mHealth device for a month
Complete a daily log for a month
Interventions/Control_3
Use a blinded mHealth device for a month
Complete a daily log for a month
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
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
college students without any restrictions on exercise or daily activities.
Persons who have received sufficient explanations about the purpose and content of this study, have the capacity to consent, voluntarily agree to participate after fully understanding, and can provide written consent to participate in this study.
Key exclusion criteria
Individuals who have been instructed by a doctor to restrict or refrain from exercise
Individuals who have plans during the study period that involve major life changes,such as moving or traveling for more than a week or restrictions in daily life.
Individuals with mental disorders, currently taking sleeping medication, who are pregnant or may be pregnant.
Individuals currently participating in other human clinical trials.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Okamura |
Organization
Chubu University
Division name
College of Life and Health Sciences
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi
TEL
0568511111
yukiko.o@fsc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Okamura |
Organization
Chubu University
Division name
College of Life and Health Sciences
Zip code
487-8501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi
TEL
0568511111
Homepage URL
yukiko.o@fsc.chubu.ac.jp
Sponsor or person
Institute
Chubu University
Institute
Department
Personal name
Funding Source
Organization
Chubu University
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
Chubu University
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi
Tel
0568511111
yukiko.o@fsc.chubu.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
| 2025 | Year | 10 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 19 | Day |
Last modified on
| 2025 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068004
