UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029853 |
|---|---|
| Receipt number | R000032535 |
| Scientific Title | The effectiveness of program to promote physical activity using activity monitor and information and communication technology: a randomized controlled trial |
| Date of disclosure of the study information | 2017/11/07 |
| Last modified on | 2022/11/10 09:40:51 |
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Basic information
Public title
The effectiveness of program to promote physical activity using activity monitor and information and communication technology: a randomized controlled trial
Acronym
Efficacy of physical activity intervention using activity monitor and ICT
Scientific Title
The effectiveness of program to promote physical activity using activity monitor and information and communication technology: a randomized controlled trial
Scientific Title:Acronym
Efficacy of physical activity intervention using activity monitor and ICT
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of physical activity intervention using activity monitor and information and ICT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical activity
Key secondary outcomes
Weight, waist circumference, percent body fat, peak oxygen uptake, and exercise self-efficacy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Phase 1 (6 months): using activity monitor and receiving feedback from coach
Phase 2 (6 months): using activity monitor
Interventions/Control_2
Phase 1 and 2 (12 months): using activity monitor
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
Participants who
1) are aged 30-59 years old
2) do not have exercise habits
3) are not restricted from exercising by a medical doctor
4) have smartphone (iOS or Android OS)
5) have never used wearable activity monitors (except for pedometer)
6) provided informed consent
Key exclusion criteria
Participants who
1) have received exercise prescription or health guidance in the past for 1 year
2) have participated in exercise intervention in the past for 1 year
3) are using a bicycle for main means of transportation
4) have a pregnant plan
5) have severe medical histories
6) are shift workers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiko Tsujimoto |
Organization
Shimane University
Division name
Faculty of Human Sciences
Zip code
Address
1060 Nishikawatsu-cho, Matsue, Shimane
TEL
0852-32-9060
tsujimoto@hmn.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiko Tsujimoto |
Organization
Shimane University
Division name
Faculty of Human Sciences
Zip code
Address
1060 Nishikawatsu-cho, Matsue, Shimane
TEL
0852-32-9060
Homepage URL
tsujimoto@hmn.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 11 | Month | 07 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 05 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032535
