UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046638 |
|---|---|
| Receipt number | R000053181 |
| Scientific Title | Effectiveness of a multicomponent intervention to promote physical activity among Japanese remote workers: A pilot randomized controlled trial |
| Date of disclosure of the study information | 2022/01/15 |
| Last modified on | 2025/08/13 19:10:16 |
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Basic information
Public title
Effectiveness of a multicomponent intervention to promote physical activity among Japanese remote workers: A pilot randomized controlled trial
Acronym
A multicomponent physical activity intervention for remote workers
Scientific Title
Effectiveness of a multicomponent intervention to promote physical activity among Japanese remote workers: A pilot randomized controlled trial
Scientific Title:Acronym
A multicomponent physical activity intervention for remote workers
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness and feasibility of a multicomponent intervention for improving physical activity among Japanese remote workers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Changes in objectively measured moderate-to-vigorous physical activity over 2 months
Key secondary outcomes
Changes in objectively measured physical activity (steps, light physical activity, moderate physical activity, and vigorous physical activity), work-related questionnaire (UWES, SWIMG-J, WHO-HPQ, and the Brief Job Stress Questionnaire), and health-related quality of life (SF-36) over 2 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
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
Minimal intervention (offering posters)
Interventions/Control_2
Multicomponent intervention which is composed of individual strategies (lecture, feedback, print material, short messages, self-monitoring, and goal setting), sociocultural environmental strategy (team-based activity), physical environmental strategy (poster), and organizational strategies (encouraging messages from an executive)
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
Men and women aged 20-65 years who understood the purpose and contents of the study and provided written informed consent
Key exclusion criteria
Those who will permanently or temporarily retire during the study
Those who cannot use a smartphone
Those who have gait disturbance
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | NAKATA |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3957
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
Faculty of Health and Sport Sciences
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3957
Homepage URL
nakata.yoshio.gn@u.tsukuba.ac.jp
Sponsor or person
Institute
Faculty of Health and Sport Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of the Faculty of Health and Sport Sciences at the University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba
Tel
029-853-2571
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
| 2022 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
https://academic.oup.com/joh/article/66/1/uiae052/7749909
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/joh/article/66/1/uiae052/7749909
Number of participants that the trial has enrolled
51
Results
There was no significant difference in the change of moderate-to-vigorous physical activity (MVPA) between the intervention and control groups. In the subdomain analysis, although no significant difference in the change of MVPA was observed between the two groups, the intervention group showed a significant increase of 9.4 minutes per day (p = 0.005) in MVPA on workdays.
Results date posted
| 2024 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 05 | Day |
Baseline Characteristics
Intervention (n = 25)
Age, years 38 (10)
Women, n (%) 9 (36)
Height, cm 169 (8)
Weight, kg* 69 (18)
Body mass index, kg/m2* 24 (5)
Current smoker, n (%) 7 (28)
Four-year college graduate, n (%) 17 (68)
Continuous years of service, years 2 (0-9)
Manager, n (%) 9 (36)
Living with one or other people, n (%) 15 (60)
Currently married, n (%) 11 (44)
Remote working day (per 5 working day)*
5 18 (75)
4 3 (13)
3 0 (0)
2 1 (4)
1 1 (4)
0 1 (4)
*n = 24
Control (n = 26)
Age, years 38 (9)
Women, n (%) 10 (39)
Height, cm 167 (10)
Weight, kg* 64 (17)
Body mass index, kg/m2* 22 (4)
Current smoker, n (%) 4 (15)
Four-year college graduate n (%) 21 (81)
Continuous years of service, years 3 (0-10)
Manager, n (%) 13 (50)
Living with one or other people, n (%) 20 (77)
Currently married, n (%) 15 (58)
Remote working day (per 5 working day)*
5 13 (54)
4 8 (33)
3 1 (4)
2 0 (0)
1 1 (4)
0 1 (4)
*n = 24
Participant flow
A total of 250 workers from the participating company were invited to participate the study, and 52 agreed to participate. At the time of baseline measurement, one participant withdrew from the study due to illness. After the baseline measurement, 51 participants were randomly allocated to either the control group (n = 26) or the intervention group (n = 25). All 51 participants completed the study, and 44 participants who met the primary outcome inclusion criteria (wearing an accelerometer for at least 3 days, with at least 10 hours of wear time per day) were included in the analysis.
Adverse events
There were no reports of adverse events from the study participants.
Outcome measures
The primary outcome of this study was the change in moderate-to-vigorous physical activity (MVPA), objectively measured using an accelerometer. The secondary outcomes were, for physical activity-related outcomes: light-intensity physical activity (LPA), moderate-intensity physical activity (MPA), vigorous-intensity physical activity (VPA), number of steps, and sedentary time (ST); and for work-related outcomes: the 9-item Utrecht Work Engagement Scale, the WHO World Mental Health Japan Survey version, the Japanese version of the Work-Life Balance Scale, the Brief Job Stress Questionnaire, and the SF-36.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 03 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053181
