UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061227 |
|---|---|
| Receipt number | R000070056 |
| Scientific Title | Effects of low-cost multicomponent workplace interventions on physical activity in Japan: a cluster randomized controlled trial |
| Date of disclosure of the study information | 2026/04/11 |
| Last modified on | 2026/04/10 15:23:56 |
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Basic information
Public title
Effects of low-cost multicomponent workplace interventions on physical activity in Japan: a cluster randomized controlled trial
Acronym
Active Workplace Trial
Scientific Title
Effects of low-cost multicomponent workplace interventions on physical activity in Japan: a cluster randomized controlled trial
Scientific Title:Acronym
Active Workplace Trial
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of a low-cost, multi-component workplace physical activity intervention on promoting physical activity among workers in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Changes in objectively measured daily step counts over a 3-month intervention period
Key secondary outcomes
Objectively measured various intensity levels of physical activity (low, moderate, and high)
Objectively measured sedentary behavior (total duration and a bout)
Work engagement (Utrecht Work Engagement Scale-9)
Work performance and absenteeism (WHO Health and Work Performance Questionnaire)
Work-Home Interaction (Japanese version of the Survey Work-Home Interaction)
Work stress (Brief Job Stress Questionnaire)
Psychological distress (Kessler Screening Scale for Psychological Distress)
Quality of life (EuroQol five-dimensional questionnaire Japanese version)
Somatic symptoms (Somatic Symptom Scale-8)
Severity of low back pain and its impact on work
Physical fitness (Maximum Step Length test, 30 Second Chair Stand Test)
Perceived benefits and obstacles of the intervention program through focus-group interviews
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
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 |
Interventions/Control_1
The intervention program consists of four different strategies.
1) Individual: email reminder, animation videos, exercise videos, leaflet, and feedback.
2) Sociocultural: step competitions, lunchtime walking
3) Physical environmental: poster, relocate trash bins and printers
4) Organizational: physical activity policy, top-down motivation, and encouragement from managers
Interventions/Control_2
Control group: being placed on a waiting list and maintaining their usual working environment without receiving any intervention during the study period.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
working in Japan; employed at least 0.6 full-time equivalent; accessible to the Internet; and able to move independently
Key exclusion criteria
being absent from work for more than two weeks during the intervention period; being pregnant during the intervention period; being relocated or retiring from work during the intervention period
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Nakata |
Organization
University of Tsukuba
Division name
Institute of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
02998533957
nakata.yoshio.gn@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Nakata |
Organization
University of Tsukuba
Division name
Institute of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
0298533957
Homepage URL
nakata.yoshio.gn@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Yoshio Nakata
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of the Institute of Health and Sport Sciences at the University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
0298532571
tg-kenkyurinri@un.tsukuba.ac.jp
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
| 2026 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070056
