UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049932 |
|---|---|
| Receipt number | R000056868 |
| Scientific Title | The effects of improved menu choice in a company cafeteria on health status among shift workers: a non-randomized controlled trial. |
| Date of disclosure of the study information | 2023/01/05 |
| Last modified on | 2024/12/30 21:22:11 |
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Basic information
Public title
The effects of improved menu choice in a company cafeteria on health status among shift workers.
Acronym
The effects of improved menu in a company cafeteria on health status among shift workers.
Scientific Title
The effects of improved menu choice in a company cafeteria on health status among shift workers: a non-randomized controlled trial.
Scientific Title:Acronym
The effects of improved menu choice in a company cafeteria on health status among shift workers: a non-randomized controlled trial.
Region
| Japan |
Condition
Condition
Workers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of improvements in canteen menu selection on the health status among shift workers using the canteen at midnight.
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
Presenteeism
Absenteeism
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
For 2-months,
consumption of healthy meals in the canteen during the night shift
weight monitoring
health education
Interventions/Control_2
Consumption of freely selected meals in the canteen during the night shift for 2-months.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1) Japanese
2) Ages>=20 years
3) Male
4) Shift workers
5) Daily users of the canteen
6) Having provided voluntary written consent for participation in this study
7) Able to receive and take experimental meals
8) Able to follow the instructions of the study team
Key exclusion criteria
1. Persons who have been diagnosed with diabetes, kidney disease, liver disease, cardio and cerebrovascular diseases by a physician, or who are taking therapeutic drugs.
2. Judged by the investigator/project leader to be ineligible for other reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Narumi |
| Middle name | |
| Last name | Nagai |
Organization
University of Hyogo
Division name
Graduate School of Human Science and Environment
Zip code
670-0092
Address
1-1-12 Shinzaike-honcho,Himeji, Hyogo
TEL
+81-79-292-1515
nagai.lab.uh@gmail.com
Public contact
Name of contact person
| 1st name | Miyoko |
| Middle name | |
| Last name | Okuzono |
Organization
University of Hyogo
Division name
Laboratory of Nutrition Education and Nutritional Physiology
Zip code
670-0092
Address
1-1-12 Shinzaike-honcho,Himeji, Hyogo
TEL
+81-79-292-1515
Homepage URL
mokuzono.mok@gmail.com
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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 | 01 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/browse/eiyogakuzashi/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/browse/eiyogakuzashi/-char/ja
Number of participants that the trial has enrolled
50
Results
In the intervention group, waist circumference tended to decrease than in the control group (median [25, 75th percentile point], intervention; -1.0 [-1.5, 1.0] cm vs. control; 0.25 [-0.95, 1.0] cm, p = 0.067). Changes in other metabolic syndrome indicators were not significantly different between the two groups. Subjective physical condition and eating attitudes scores were significantly higher in the intervention group than in the control group.
Results date posted
| 2022 | Year | 12 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
The participants 48 male shift workers were randomly assigned by age median age 41 years old and body mass index obese 25 kg/m2 or more to intervention n=23 and control n= 25 groups
Participant flow
The intervention group received a 20-min nutritional education session and consumed a healthy set menu at the company canteen during the nightshift 16 times over two months. The control group consumed their ordinary menu items during the same period.
Adverse events
No adverse events were observed in the participants.
Outcome measures
Data on body weight, body composition, blood pressure, biochemical parameters, physical condition, and eating attitudes were obtained from pre- and post-intervention measurements.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | 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
| 2024 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056868
