UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038777 |
|---|---|
| Receipt number | R000043520 |
| Scientific Title | Beauty & healThy Project |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2021/04/26 15:27:10 |
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Basic information
Public title
Beauty & healThy Project
Acronym
BeauThy project
Scientific Title
Beauty & healThy Project
Scientific Title:Acronym
BeauThy project
Region
| Japan |
Condition
Condition
Normal weight obesity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop an health educational program for those who are normal weight obesity to reduce body fat and validate the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body fat rate
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Provide a health educational program
Interventions/Control_2
Provide existing information (conventional method)
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
People who fulfill all of the following requirements when they are registered.
1. 18.5 =< Body Mass Index (BMI)(Kg/m2) < 25
2. Body fat rate is over 20% (for male) or over 30% (for female).
3. Can communicate in Japanese fluently.
4. Can use an App, which use in the study.
Key exclusion criteria
People who do not meet one of following requirements when they are registered.
1. Under treat or have history of treating cardiovascular diseases, and doctors limit their movement because of the disease.
2. Under treat of Diabetes mellitus, kidney diseases, kidney disease, respiratory disease, orthopedic diseases, congenital diseases, neuromuscular diseases, and doctors limit their movement because of the disease.
3. The pregnant or people who might be during pregnancy.
4. Less than three months after the birth.
5. Had been registered other intervention for the purpose of reducing body fat(rate) or improving 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
Health Services
Zip code
6068501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto, JAPAN
TEL
+81757532401
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
6068501
Address
Yoshida-honmachi, Sakyo-ku, Kyoto, JAPAN
TEL
+81757532431
Homepage URL
konda.manako.53v@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Kyoto 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
Kyoto university Graduate school and faculty of medicine, ethics committee
Address
Yoshida-konoecho, Sakyo-ku, Kyoto, JAPAN
Tel
+81757534680
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 | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 12 | Month | 03 | Day |
Last modified on
| 2021 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043520
