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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

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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
Email 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
Email 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

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 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
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


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