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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024069 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Not applicable
Adult |
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Classification by specialty |
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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 |
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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. |
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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. |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Japanese workers employed by the employer of the worksites
2) White-collar workers |
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Key exclusion criteria | None | |||
Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Mental Health, Graduate School of Medicine, The University of Tokyo |
Institute | |
Department |
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 |
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IRB Contact (For public release) | |
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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 |
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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 |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027716 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |