UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039847 |
|---|---|
| Receipt number | R000045175 |
| Scientific Title | Beauty & healThy (BeauThy) Project Risks of lifestyle in normal weight obese university students |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2020/09/25 12:55:10 |
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Basic information
Public title
Beauty & healThy (BeauThy) Project
Risks of lifestyle in normal weight obese university students
Acronym
Beauty & healThy (BeauThy) Project
Risks of lifestyle in normal weight obese university students
Scientific Title
Beauty & healThy (BeauThy) Project
Risks of lifestyle in normal weight obese university students
Scientific Title:Acronym
Beauty & healThy (BeauThy) Project
Risks of lifestyle in normal weight obese university students
Region
| Japan |
Condition
Condition
normal weight obesity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop a health education program for normal weight obese people to reduce their body fat rate, and verify its effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changing in body fat rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Offering the health education program
Interventions/Control_2
Offering information (as same as current correspondence)
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Meet the normal weight obesity criteria.
(Male: 18.5 =< BMI (kg/m2) < 25 and body fat rate (%) >= 20
Female: 18.5 =< BMI (kg/m2) < 25 and body fat rate (%) >= 30)
2. Fluent in Japanese.
3. Capable to use smart phone application.
Key exclusion criteria
1. Under treatment or have history of cardiovascular diseases and limited ones' physical activity by doctors.
2. Under treatment of diabetes mellitus, kidney diseases, respiratory diseases, orthopedic diseases, congenital diseases, neuromuscular disease and limited ones' physical activity by doctors.
3. The period of pregnancy or have possibility of it.
4. Within three months of childbirth.
5. Participants of intervention programs to reduce body fat rate or to improve body composition.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University
Division name
Agency for Health, Safety and Environment
Zip code
606-8501
Address
Yoshidahon-machi, Sakyo-ku, Kyoto
TEL
075-753-2401
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Manako |
| Middle name | |
| Last name | Konda |
Organization
Kyoto University
Division name
School of Public Health Department of Preventive Services
Zip code
606-8501
Address
Yoshidahon-machi, Sakyo-ku, Kyoto
TEL
075-753-2431
Homepage URL
konda.manako.53v@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
The Cardiovascular Research Fund (Tokyo, JAPAN)
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
Kyoto university Graduate school and faculty of medicine, ethics committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2020 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2020 | Year | 03 | Month | 17 | Day |
Last modified on
| 2020 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045175
| 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 |
