UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051693 |
|---|---|
| Receipt number | R000058993 |
| Scientific Title | Intervention study (pre-post comparison test) |
| Date of disclosure of the study information | 2023/07/26 |
| Last modified on | 2023/07/24 01:38:05 |
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Basic information
Public title
Factors Affecting Weight Changes in High school athletes
Acronym
Factors Affecting Weight Changes in High school athletes
Scientific Title
Intervention study (pre-post comparison test)
Scientific Title:Acronym
Intervention study (pre-post comparison test)
Region
| Japan |
Condition
Condition
Low nutrition
Classification by specialty
| Medicine in general | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the relationship between dietary patterns, fatigue, sports nutrition knowledge, and weight change
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BMI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The program consists of four seminars and individual supports on sports nutrition
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
| 16 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A healthy high school student in high school athletic club
Key exclusion criteria
Those who are undergoing treatment for diseases that require dietary therapy. However, if the attending physician permits participation in the research, it is eligible. Those who have stopped exercising due to injury, etc., are excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Hachiya |
Organization
Tenshi College
Division name
Department of Nutrition, Faculty of Nursing and Nutrition
Zip code
0650013
Address
Kita-13, Higashi-3, Higashi-ku, Sapporo, Japan
TEL
0117411051
hachiya.megumi@tenshi.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Hachiya |
Organization
Tenshi College
Division name
Department of Nutrition, Faculty of Nursing and Nutrition
Zip code
0650013
Address
Kita-13, Higashi-3, Higashi-ku, Sapporo, Japan
TEL
0117411051
Homepage URL
hachiya.megumi@tenshi.ac.jp
Sponsor or person
Institute
Tenshi College
Institute
Department
Personal name
Funding Source
Organization
Tenshi College
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
Tenshi College
Address
Kita-13, Higashi-3, Higashi-ku, Sapporo, Japan
Tel
0117411051
hachiya.megumi@tenshi.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 | 07 | Month | 26 | 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
| 2023 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | 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 | 07 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058993
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
