UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053861 |
|---|---|
| Receipt number | R000061478 |
| Scientific Title | The effectiveness trial of occupational lifestyle intervention enhancing physical activity, preventing musculoskeletal health, and improving work environment of teleworkers: a cluster randomized controlled trial (TELEWORK Study) |
| Date of disclosure of the study information | 2024/03/15 |
| Last modified on | 2024/03/14 14:49:10 |
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Basic information
Public title
The effectiveness trial of occupational lifestyle intervention enhancing physical activity, preventing musculoskeletal health, and improving work environment of teleworkers: a cluster randomized controlled trial (TELEWORK Study)
Acronym
The effectiveness trial of occupational lifestyle intervention enhancing physical activity, preventing musculoskeletal health, and improving work environment of teleworkers: a cluster randomized controlled trial (TELEWORK Study)
Scientific Title
The effectiveness trial of occupational lifestyle intervention enhancing physical activity, preventing musculoskeletal health, and improving work environment of teleworkers: a cluster randomized controlled trial (TELEWORK Study)
Scientific Title:Acronym
The effectiveness trial of occupational lifestyle intervention enhancing physical activity, preventing musculoskeletal health, and improving work environment of teleworkers: a cluster randomized controlled trial (TELEWORK Study)
Region
| Japan |
Condition
Condition
Not applicable (Adult)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to examine the effect of a comprehensive, multi-component occupational lifestyle intervention on teleworkers' physical activity, musculoskeletal health, and work environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Objectively measured number of steps (before and 3 months after intervention)
Key secondary outcomes
1) Objectively measured physical activity (low-intensity, moderate-intensity, and high-intensity physical activity time, as well as sedentary time)
2) Work engagement (Utrecht Work Engagement Scale)
3) Work productivity (WHO Health and Work Performance Questionnaire)
4) Mental health (K6)
5) Work environment (home and office, subjectively and objectively measured) (SAP-Subjective Assessment of workplace Productivity)
6) Work environment improvement actions
7) Physical symptoms (Somatic Symptom Scale-8)
8) Presence and severity of low back pain and its impact on work
9) Attitudes toward low back pain
10) Frequency of low back pain exercises
Above outcomes will be measured before and 3 months after intervention
11) Subjective improvement of low back pain (Patient Global Impression of Change) after intervention
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
Intervention group
The intervention program consist of three components as follows:
1) Physical activity promotion
Online lectures and distribution of lecture materials
Competitions on the number of steps taken
Feedback on physical activity
2) Musculoskeletal health
Online lectures and distribution of lecture materials
Distribution of pamphlets
3) Work environment improvement
Online lectures and distribution of lecture materials
The abovementioned program will be delivered through our website and periodic messages to encourage healthy behaviors. Moreover, messages of recommendations from the upper management in the workplace will be delivered.
Not necessarily all intervention components will be implemented.
Control group
No education (wait-list control)
Interventions/Control_2
Control group
No education (wait-list control)
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
1) Healthy adults
2) Home-based teleworkers for at least one day per week
Key exclusion criteria
1) Persons who are prohibited from exercising by their doctors
2) Persons who are planning long-term business trips or retirement during the study
3) Persons who are pregnant or possibly pregnant
4) Persons whose participation is deemed inappropriate by the research director
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Kai |
Organization
Public Interest Corporation Meiji Yasuda Life Foundation of Health and Welfare
Division name
Physical Fitness Research Institute
Zip code
192-0001
Address
150 Tobuki, Hachioji, Tokyo
TEL
042-691-1163
y-kai@my-zaidan.or.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Wada |
Organization
Public Interest Corporation Meiji Yasuda Life Foundation of Health and Welfare
Division name
Physical Fitness Research Institute
Zip code
192-0001
Address
150 Tobuki, Hachioji, Tokyo
TEL
042-691-1163
Homepage URL
ay-wada@my-zaidan.or.jp
Sponsor or person
Institute
Public Interest Corporation Meiji Yasuda Life Foundation of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tsukuba University, Teikyo University, Showa University, Tokyo Medical and Dental University, Tokyo Institute of Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Yasuda Life Foundation of Health and Welfare Research Ethics Review Board for Research Involving Human Subjects
Address
150 Tobuki, Hachioji, Tokyo
Tel
042-691-1163
yoshida@my-zaidan.or.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
| 2024 | Year | 03 | Month | 15 | 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
| 2024 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 03 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061478
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
