UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044781 |
|---|---|
| Receipt number | R000050753 |
| Scientific Title | Research on continuous practice of health and nutrition education and its effective education methods in factory workers |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2023/01/07 16:00:41 |
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Basic information
Public title
Research on continuous practice of health and nutrition education and its effective education methods in factory workers
Acronym
Research on continuous practice of health and nutrition education and educational methods
Scientific Title
Research on continuous practice of health and nutrition education and its effective education methods in factory workers
Scientific Title:Acronym
Research on continuous practice of health and nutrition education and educational methods
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine companies and universities will collaborate to provide health and nutrition education to factory workers, whether will have an effect on the consciousness, behavior and physical condition of workers, and consider effective education methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic blood pressure
Diastolic blood pressure
Evaluation of secular change due to workplace medical examination
Baseline is 2018
Final evaluation is 2023
Key secondary outcomes
Body weight
blood glucose and serum lipids
Changes of awareness and behavior in worker
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have approved of this research in factory workers belonging to the same company.
Key exclusion criteria
No exclusion criteria for health and nutriti
on education interventions.
In the verification of the effect on blood p
ressure, taking antihypertensive drugs is ex
cluded.
Target sample size
850
Research contact person
Name of lead principal investigator
| 1st name | mari |
| Middle name | |
| Last name | honda |
Organization
Kobe Women's University
Division name
Department of Health, Sports, and Nutrition, Faculty of Health and Welfare
Zip code
650-0046
Address
4-7-2, Minatojima-nakamachi, Kobe Chuo-ku, Hyogo 650-0046, Japan
TEL
078-303-4700
mhonda@kwjc.kobe-wu.ac.jp
Public contact
Name of contact person
| 1st name | mari |
| Middle name | |
| Last name | honda |
Organization
Kobe Women's University
Division name
Department of Health, Sports, and Nutrition, Faculty of Health and Welfare
Zip code
650-0046
Address
4-7-2, Minatojima-nakamachi, Kobe Chuo-ku, Hyogo 650-0046, Japan
TEL
078-303-4700
Homepage URL
mhonda@kwjc.kobe-wu.ac.jp
Sponsor or person
Institute
Kobe Women's University
Institute
Department
Personal name
Funding Source
Organization
Kobe Women's 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
Kobe Women's University / Kobe Women's Junior College Research Ethics Committee for Humans
Address
4-7-2, Minatojima-nakamachi, Kobe Chuo-ku, Hyogo 650-0046, Japan
Tel
078-303-4700
d-kimura@yg.kobe-wu.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
| 2021 | Year | 08 | 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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study by practicing continuous health and nutrition education.
Providing health menus and mochi barley rice using the employee cafeteria and providing information through posting media.
The period is about 3 months / year.
Evaluation based on data from workplace medical examinations and original questionnaires.
Management information
Registered date
| 2021 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050753
