UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057575 |
|---|---|
| Receipt number | R000065783 |
| Scientific Title | Exploring teaching methods for increasing muscle mass in working people. |
| Date of disclosure of the study information | 2025/04/14 |
| Last modified on | 2025/10/10 09:31:50 |
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Basic information
Public title
Exploring teaching methods for increasing muscle mass in working people.
Acronym
Exploring teaching methods for increasing muscle mass in working people.
Scientific Title
Exploring teaching methods for increasing muscle mass in working people.
Scientific Title:Acronym
Exploring teaching methods for increasing muscle mass in working people.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a survey on changes in diet, exercise habits and muscle mass before and after the intervention in working people to explore better ways to increase muscle mass by providing dietary guidance, exercise guidance or both to increase muscle mass.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass 12 months after the start of the study.
Key secondary outcomes
Body composition(body weight,BMI,fat mass)
Physical performance(number of steps,knee extension strength,handgrip strength)
Physical activity
Nutrient intake(energy,protein,fat)
Questionnaire(diet,exercise habits)
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
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1) Assessment of body composition and guidance
2) Distribution of information on diet and exercise for 11 months
3) Individual guidance 6 months after implementation of information distribution
Interventions/Control_2
1) Assessment of body composition and guidance
2) Distribution of information on diet for 11 months
3) Individual guidance 6 months after implementation of information distribution
Interventions/Control_3
1) Assessment of body composition and guidance
2) Distribution of information on exercise for 11 months
3) Individual guidance 6 months after implementation of information distribution
Interventions/Control_4
Assessment of body composition and guidance
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Workers aged 20 years and over
Able to continuously participate in the study for one year
Own a smartphone and able to acquire the application
Able to carry a pedometer at all times
Key exclusion criteria
You have special dietary or exercise restrictions from your doctor.
You have a cardiac pacemaker.
You are pregnant or may be pregnant.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | chikako |
| Middle name | |
| Last name | takaya |
Organization
Osaka Rosai Hospital Resarch Center for the Promotion of Health and Employment Support
Division name
Division of Preventive Medicine
Zip code
591-8025
Address
1179-3,Nagasone-Cho,Kita-Ku,Sakai-City,Osaka Pref,Japan
TEL
0722523561
c_takaya@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | chikako |
| Middle name | |
| Last name | takaya |
Organization
Osaka Rosai Hospital Resarch Center for the Promotion of Health and Employment Support
Division name
Division of Preventive Medicine
Zip code
591-8025
Address
1179-3,Nagasone-Cho,Kita-Ku,Sakai-City,Osaka Pref,Japan
TEL
0722523561
Homepage URL
c_takaya@osakah.johas.go.jp
Sponsor or person
Institute
Japan Organization of Occupational Health and Safety
Institute
Department
Personal name
Funding Source
Organization
Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Rosai Hospital Resarch Center for the Promotion of Health and Employment Support
Address
1179-3,Nagasone-Cho,Kita-Ku,Sakai-City,Osaka Pref,Japan
Tel
0722523561
c_takaya@osakah.johas.go.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 | 04 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | 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 | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065783
