UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045493 |
|---|---|
| Receipt number | R000051937 |
| Scientific Title | Development of an online lifestyle-related improvement program aimed at increasing physical activity for teleworkers: RCT program |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2023/09/19 11:47:11 |
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Basic information
Public title
Development of an online lifestyle-related improvement program aimed at increasing physical activity for teleworkers
Acronym
Development of an online lifestyle-related improvement program aimed at increasing physical activity for teleworkers
Scientific Title
Development of an online lifestyle-related improvement program aimed at increasing physical activity for teleworkers: RCT program
Scientific Title:Acronym
Development of an online lifestyle-related improvement program aimed at increasing physical activity for teleworkers: RCT program
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to develop a three-month online health education program for teleworking workers to increase physical activity. In addition, a randomized controlled trial (RCT) will be conducted using the program to clarify the effect of the intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-step test score
Key secondary outcomes
Stages of behavior change, physical activity, locomotive level, lifestyle, mental health, self-efficacy, BMI, blood pressure, muscle strength, muscle endurance, balance, flexibility, walking speed
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the first half, group A will be the intervention group and group B will be the control group.
Intervention: Conducting a three-month online health education program for teleworking workers to increase physical activity.
Interventions/Control_2
Control: Group B will carry out the same program after the program of Group A is completed.
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male and female workers aged 30 to 59 who are teleworking
2. It is possible to access the internet
3. Those who can record the practice status of the program by themselves
Key exclusion criteria
1. Experienced hospitalization or surgery for orthopedic disease within 3 months
2. Participating in other health-related programs
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Rumi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Health Care Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5350
r-tsukinoki.phn@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Shiomitsu |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Health Care Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5350
Homepage URL
ns173001@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine Research Ethics Committee, Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-58033-5096
syomu1.adm@tmd.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
東京医科歯科大学(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Reason for cancellation:
It was pointed out that the protocol needed to be revised, so the ethical review application was temporarily withdrawn in order to review the content.
Because the application was registered before ethical review approval, a provisional date was entered as the date of approval by the ethics committee.
We are currently revising the protocol and submitting a new application for ethical review, but the research design will be changed to a cluster RCT and the title of the project will also be changed.
This research will be "research discontinued."
Management information
Registered date
| 2021 | Year | 09 | Month | 15 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051937
