UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036044
Receipt No. R000041056
Scientific Title The effect of health and productivity management strategy based food environmental interventions on employee's salt intakes.
Date of disclosure of the study information 2019/03/01
Last modified on 2019/02/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effect of health and productivity management strategy based food environmental interventions on employee's salt intakes.
Acronym The effect of food environmental interventions on employee's salt intakes.
Scientific Title The effect of health and productivity management strategy based food environmental interventions on employee's salt intakes.
Scientific Title:Acronym The effect of food environmental interventions on employee's salt intakes.
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 intakes,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 Part-time workers
Patients with chronic kidney disease,
patients with kidney failure


Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukari Takemi
Organization Kagawa Nutrition University
Division name Nutrition Ecology
Zip code
Address 3-9-21 Chiyoda Sakado Saitama
TEL 049-282-3721
Email takemi@eiyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Sakaguchi
Organization Graduate school of Kagawa Nutrition University
Division name Nutrition Ecology
Zip code
Address 3-9-21 Chiyoda Sakado Saitama
TEL 049-282-3721
Homepage URL
Email skb161@eiyo.ac.jp

Sponsor
Institute Kagawa Nutrition University
Institute
Department

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
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2019 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 21 Day
Last follow-up date
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
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041056

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.