UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057647 |
|---|---|
| Receipt number | R000065855 |
| Scientific Title | A study on weight loss and menstruation in high school girls |
| Date of disclosure of the study information | 2025/05/15 |
| Last modified on | 2025/04/18 07:49:53 |
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Basic information
Public title
A study on weight loss and menstruation in high school girls
Acronym
A study on weight loss and menstruation in high school girls
Scientific Title
A study on weight loss and menstruation in high school girls
Scientific Title:Acronym
A study on weight loss and menstruation in high school girls
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the current status of menstrual abnormalities and thinness among female high school students and to assess the impact of subsequent nutrition education on behavior change.
Basic objectives2
Others
Basic objectives -Others
To ascertain high school girls' knowledge of menstrual status and premenstrual syndrome. In addition, the desire to be thin and body shape perception will be determined. Then, nutrition and health education will be provided, with the aim of assessing changes in thinness desire and body shape perception distortions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body shape perception (body image)
Knowledge of health disorders
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
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We will hold a seminar focusing on the following two points: 1) The disadvantages of being thin 2) Actions to maintain health (diet and exercise)
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Female
Key inclusion criteria
Participants in the study will be limited to those who have given consent to an explanation of the study from both their guardians and themselves.
Key exclusion criteria
Female students who do not give consent for the study will be excluded.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Inaba |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata, JAPAN
TEL
0252574413
inaba@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Inaba |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition, Faculty of Health Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata, Japan
TEL
0252574413
Homepage URL
inaba@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Hiromi Inaba
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, niigata, 950-3198 JAPAN
Tel
0252574413
inaba@nuhw.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 | 05 | Month | 15 | 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 | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 04 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065855
