UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051680 |
|---|---|
| Receipt number | R000058974 |
| Scientific Title | Citizens' health promotion using body composition and bone densitometers and subsequent behavior change |
| Date of disclosure of the study information | 2023/08/25 |
| Last modified on | 2023/07/21 15:49:19 |
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Basic information
Public title
Citizens' health promotion using body composition and bone densitometers and subsequent behavior change
Acronym
Citizens' health promotion using body composition and bone densitometers and subsequent behavior change
Scientific Title
Citizens' health promotion using body composition and bone densitometers and subsequent behavior change
Scientific Title:Acronym
Citizens' health promotion using body composition and bone densitometers and subsequent behavior change
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the direction of future health promotion project measures suited to local characteristics, based on analysis of citizens' body composition and bone density data and a questionnaire-based behaviour change survey.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition (Analysis by InBody; skeletal muscle mass (segmental analysis), weight, body fat mass (segmental analysis), body fat percentage, SMI, BMI.
Key secondary outcomes
Body composition (Analysis by InBody; body water content, skeletal muscle mass, total protein mass, total mineral content, basal metabolic rate, visceral fat level, body impedance (segmental analysis).
bone mineral density
questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Body composition
bone mineral density
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2)Adults over 18 years old
Key exclusion criteria
1)persons under 18
2) persons who did not get consent
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Shimizu |
Organization
nayoro city university
Division name
faculty of health and welfare science
Zip code
096-8641
Address
8-1, Nishi 4-jo Kita 8-chome, Nayoro, Hokkaido 096-8641,Japan
TEL
0165424194
shimizu@nayoro.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Shimizu |
Organization
nayoro city university
Division name
faculty of health and welfare science
Zip code
096-8641
Address
8-1, Nishi 4-jo Kita 8-chome, Nayoro, Hokkaido 096-8641,Japan
TEL
0165424194
Homepage URL
shimizu@nayoro.ac.jp
Sponsor or person
Institute
nayoro city university
Institute
Department
Personal name
Funding Source
Organization
nayoro city university
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
nayoro city office
Address
1-1 Odori Minami, Nayori-shi, Hokkaido Japan
Tel
01654-3-2111
nayoro@city.nayoro.lg.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 | 08 | Month | 25 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058974
