UMIN-CTR Clinical Trial

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
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IRB Contact (For public release)
Organization
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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	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
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Research case data
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