UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and preliminary trial of the program for improving work performance
Title of the study (Brief title)	Development and preliminary trial of the program for improving work performance
Region	Japan

Condition
Condition	none
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development and improvement of the self-care program for workers by collecting measurement outcomes and impressions.
Basic objectives2	Others
Basic objectives -Others	Since pre-post design, accomplishing efficacy for the program is difficult
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	total time of light physical activity in weekdays and of moderate and vigorous physical activity in weekends assessed by an accelerometer at post-intervention compared to pre-intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Group acceptance & commitment tTherapy; Ninety minutes in two times over 2 weeks
Interventions/Control_2
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Currently employed
Key exclusion criteria	None
Target sample size	15

Research contact person
Name of lead principal investigator	Masao Tsuchiya
Organization	National Institute of Occupational Safety and Health, Japan
Division name	Health Administration and Psychosocial Factor Research Group
Address	6-21-1 Nagao, Tama-Ku, Kawasaki 214-8585 Japan
TEL	044-865-6111
Email	tsuchiya@h.jniosh.johas.go.jp

Public contact
Name of contact person	Masao Tsuchiya
Organization	National Institute of Occupational Safety and Health, Japan
Division name	Health Administration and Psychosocial Factor Research Group
Address	6-21-1 Nagao, Tama-Ku, Kawasaki 214-8585 Japan
TEL	044-865-6111
Homepage URL
Email	tsuchiya@h.jniosh.johas.go.jp

Sponsor
Institute	National Institute of Occupational Safety and Health, Japan
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science(JSPS)
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 24 Day
Anticipated trial start date	2016 Year 05 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 02 Day
Last modified on	2017 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026022