UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049248 |
|---|---|
| Receipt number | R000056091 |
| Scientific Title | Survey research on physical activity, mental health, perceived stress, and health status of undergraduate and graduate students |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2023/07/12 17:00:38 |
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Basic information
Public title
Survey research on physical activity, mental health, perceived stress, and health status of undergraduate and graduate students
Acronym
Survey research on physical activity, mental health, perceived stress, and health status
Scientific Title
Survey research on physical activity, mental health, perceived stress, and health status of undergraduate and graduate students
Scientific Title:Acronym
Survey research on physical activity, mental health, perceived stress, and health status
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate physical activity, mental health, perceived stress, and health status among undergraduate and graduate students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity
Key secondary outcomes
Mental health, Perceived stress, Health status
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Participants who are 3rd or 4th undergraduate or graduate students.
2. Participants who have no medical or surgical disorders.
Key exclusion criteria
1. Participants who are not 3rd or 4th undergraduate or graduate students.
2. Participants who have medical or surgical disorders.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | TAKUMA |
| Middle name | |
| Last name | YANAOKA |
Organization
Hiroshima University
Division name
Graduate school of Humanities and Social Sciences
Zip code
739-8524
Address
kagamiyama 1-1-1 Higashi-Hiroshima
TEL
082-424-6846
yanaoka@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKUMA |
| Middle name | |
| Last name | YANAOKA |
Organization
Hiroshima University
Division name
Graduate school of Humanities and Social Sciences
Zip code
739-8524
Address
kagamiyama 1-1-1 Higashi-Hiroshima
TEL
0824246846
Homepage URL
yanaoka@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board, Graduate School of Humanities and Social Sciences, Hiroshima University
Address
kagamiyama 1-1-1 Higashi-Hiroshima
Tel
082-424-6705
ed-ken-zai@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
| 2022 | 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
60
Results
In all participants and males, Fat-Free mass index (FFMI) has significant correlations between vigorous-intensity PA (VPA), moderate-intensity PA, moderate-vigorous PA , total PA and sedentary time. In females, FFMI has a significant correlation with VPA.
Regarding FFMI and health status, there was significant correlations FFMI and total cholesterol and LDL cholesterol in all participants. In females, FFMI has a significant correlation with HDL cholesterol.
Results date posted
| 2023 | Year | 07 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
67 participants who are the students of Hiroshima University were employeed in present study. All participants were healthy young adults with no smoking.
Seven partisipants were excluded from the statistical analysis due to missing data.
Participant flow
Participants visited the laboratory three times for measurements.
Day 1 , participants were measured body compositon and physical activity.
Day 2 , participants conducted the questionairs about mental health and percieved stress.
Day 3 , participants were collected venous blood samples after 10 hours overnight fasting.
Adverse events
Outcome measures
Body composition, physical activity, mental health, percieved stress, glucose, triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 19 | 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
None
Management information
Registered date
| 2022 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056091
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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