UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051496 |
|---|---|
| Receipt number | R000058746 |
| Scientific Title | Effects of food-environment approaches in work places on reducing health risks among workers with various work patterns: Single-center, pre- and post-comparison study. |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2024/12/31 11:30:49 |
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Basic information
Public title
Research to promote the health of workers and to improve the food environment for workers.
Acronym
Research to promote the health of workers and to improve the food environment for workers.
Scientific Title
Effects of food-environment approaches in work places on reducing health risks among workers with various work patterns: Single-center, pre- and post-comparison study.
Scientific Title:Acronym
Effects of food-environment approaches in work places on reducing health risks among workers.
Region
| Japan |
Condition
Condition
workers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of interventions conducted through healthy eating environments, includes health education to promote healthy food and beverage, using anthropometric and lifestyle-related disease risk indicators as primary outcomes among workers with various work patterns. Then, as a sub-analysis, to categorize the workers into groups based on work patterns and also to evaluate the effects of the intervention for each group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anthropometric parameters: BMI, body composition, waist circumference
Biochemical parameters
Key secondary outcomes
Nutritional and food intakes
Eating behaviors
Physical activity
Lifestyle behaviors
Meal timing
Meal contents and meal pattern
Food and beverage consumption
Sleep-wake cycle
Psychological parameters
Physiological parameters
Biological parameters (urine)
Presenteeism
Absenteeism
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
| Food | Behavior,custom | Other |
Interventions/Control_1
2 months of workplace food environment improvement (improved access to healthy menus and beverages) and health education for employees to promote healthy food choices.
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. Japanese
2. Ages >= 18 years
3. Workers at a participant company who have undergone a medical examination
4. Having provided voluntary written consent for participation in this study
5. Able to follow the instructions of the research team member
Key exclusion criteria
1. Workers who have been diagnosed with diabetes, kidney disease, liver disease, cardio and cerebrovascular diseases by a physician, or who are taking therapeutic drugs.
2. Pregnant women
3. Judged by the investigator/project leader to be ineligible for other reason
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Narumi |
| Middle name | |
| Last name | Nagai |
Organization
University of Hyogo
Division name
School of Human Science and Environment
Zip code
6700092
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL
+81-79-292-1515
nagai.lab.uh@gmail.com
Public contact
Name of contact person
| 1st name | Narumi |
| Middle name | |
| Last name | Nagai |
Organization
University of Hyogo
Division name
Laboratory of Nutrition Education and Physiology, School of Human Science and Environment
Zip code
6700092
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL
+81-79-292-9405
Homepage URL
nagai.lab.uh@gmail.com
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research provided by Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The SHSE (School of Human Science and Environment) Research Ethics Committee of the University of Hyogo
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo
Tel
+81-79-292-1515
u_hyogo_kankyou@ofc.u-hyogo.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
| 2023 | Year | 07 | 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
391
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 30 | Day |
Last modified on
| 2024 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058746
