UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036044 |
|---|---|
| Receipt number | R000041056 |
| Scientific Title | Effect of workplace dietary intervention on salt intake and sodium-to-potassium ratio of Japanese employees: A quasi-experimental study |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2021/11/30 05:27:53 |
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Basic information
Public title
The Effect of Food Environmental Interventions-based Health and Productivity Management Strategy on Employees' Salt Intake
Acronym
The effect of food environmental interventions on Employees' Salt Intake
Scientific Title
Effect of workplace dietary intervention on salt intake and sodium-to-potassium ratio of Japanese employees: A quasi-experimental study
Scientific Title:Acronym
Effect of workplace dietary intervention on salt intake and sodium-to-potassium ratio of Japanese employees: A quasi-experimental study
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the effect of health and productivity management strategy based food environmental interventions on employee's salt intake,urinary sodium-to-potassium ratio.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
amount of salt intake(urinary sodium excretion)
Key secondary outcomes
Urinary sodium-to-potassium ratio
Body weight, height, blood pressure
Lifestyle factors such as diet, exercise and drinking
Healthy Eating Literacy
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Other |
Interventions/Control_1
Adopting health and productivity management strategy
Improving food accessibility
Improving information accessibility
Interventions/Control_2
Evaluation only (The interventions will be offered at the comparison site after the evaluation is complete).
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Full-time workers aged 18 to 70
Key exclusion criteria
Top of the company
The person in charge that served as the point of contact
Target sample size
138
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Takemi |
Organization
Kagawa Nutrition University
Division name
Nutrition Ecology
Zip code
3500288
Address
3-9-21 Chiyoda Sakado Saitama
TEL
049-282-3721
takemi@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Graduate school of Kagawa Nutrition University
Division name
Nutrition Ecology
Zip code
3500288
Address
3-9-21 Chiyoda Sakado Saitama
TEL
049-282-3721
Homepage URL
sakaguchi.keiko@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
Kagawa Nutrition University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Committee of Kagawa Nutrition University
Address
3-9-21 Chiyoda Sakado Saitama
Tel
049-282-3721
skb161@eiyo.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
女子栄養大学（埼玉県）/ Kagawa Nutrition University（Saitama Pref.）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34731526/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34731526/
Number of participants that the trial has enrolled
137
Results
Salt intake in the intervention workplace decreased significantly from 10.7 to 9.3 g (-1.4 g change; 95% confidence interval [CI]: [-2.4, -0.5]). The adjusted difference in changes in salt intake between workplaces was statistically significant (-3.7 g change; 95% CI: [-5.2, -2.3]).
Results date posted
| 2021 | Year | 11 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See the article below.
https://pubmed.ncbi.nlm.nih.gov/34731526/
Participant flow
See the article below.
https://pubmed.ncbi.nlm.nih.gov/34731526/
Adverse events
N/A
Outcome measures
See the article below.
https://pubmed.ncbi.nlm.nih.gov/34731526/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 28 | Day |
Last modified on
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041056
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
