UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024069 |
|---|---|
| Receipt number | R000027716 |
| Scientific Title | An intervention study for health promoting workplace environment to improve physical activity among white-collar workers: a cluster randomized controlled study |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2018/09/17 09:44:17 |
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Basic information
Public title
An intervention study for health promoting workplace environment to improve physical activity among white-collar workers: a cluster randomized controlled study
Acronym
An intervention study to improve physical activity among workers
Scientific Title
An intervention study for health promoting workplace environment to improve physical activity among white-collar workers: a cluster randomized controlled study
Scientific Title:Acronym
An intervention study to improve physical activity among workers
Region
| Japan |
Condition
Condition
Not applicable
Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the effectiveness of an intervention program for health promoting workplace environment on improving physical activity among white-collar workers, comparison with a control treatment (only receiving feedback of assessment and basic occupational health service). We also aim to examine the effectiveness of the intervention program on reducing psychological distress, and improving self-regulation for physical activity and subjective health among white-collar workers as secondary outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical activity (before randomization, and 3 and 6 months after intervention)
Physical activity will be measured by a self-report questionnaire (Global Physical Activity Questionnaire, GPAQ)
Key secondary outcomes
1) Psychological distress measured by the Brief Job Stress Questionnaire (BJSQ)
2) Self-regulation for physical activity measured by Physical Activity Self-Regulation scale (PASR-12)
3) Subjective health measured by a "Generally, how much better do you feel about your health?"
All outcomes will be measured before randomization, and 3 and 6 months after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
A 3-month structured intervention program developed by the concept of a scale that assesses health promoting workplace environment (the Environmental Assessment Tool, DeJoy et al., 2008; Watanabe et al., 2016). The program will be tailored based on the pre-assessment at before randomization using the EAT.
The program consists of core-programs which approach workplace environment considered effective to improve physical activity (written policy and psychological education), and optional-programs which approach other workplace environment, selected by each worksite.
Interventions/Control_2
A control treatment: three times feedback of assessment of the amount of physical activity and basic occupational health service
This control treatment will also be applied for the intervention group.
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 workers employed by the employer of the worksites
2) White-collar workers
Key exclusion criteria
None
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Watanabe |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81358413522
kzwatanabe-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Watanabe |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81358413522
Homepage URL
kzwatanabe-tky@umin.ac.jp
Sponsor or person
Institute
Department of Mental Health, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS), Grant-in-Aid for JSPS Fellows
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本の関東地方に所在する事業所 (詳細未定)
Worksites located in Kanto area, Japan
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs12529-018-9747-7
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
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 15 | Day |
Last modified on
| 2018 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027716
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
