UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034114 |
|---|---|
| Receipt number | R000038892 |
| Scientific Title | Community-wide promotion of physical activity by utilizing neighboring environmental data obtained from geographic information system. |
| Date of disclosure of the study information | 2018/09/13 |
| Last modified on | 2018/09/13 10:08:38 |
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Basic information
Public title
Community-wide promotion of physical activity by utilizing neighboring environmental data obtained from geographic information system.
Acronym
Community-wide promotion of physical activity
Scientific Title
Community-wide promotion of physical activity by utilizing neighboring environmental data obtained from geographic information system.
Scientific Title:Acronym
Community-wide promotion of physical activity
Region
| Japan |
Condition
Condition
Physical inactivity
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of community-wide promotion on increasing physical activity among older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in physical activity obtained by two independent questionnares at baseline (February 2016) and follow-up (February 2018).
Key secondary outcomes
Differences in perceived environmental attributes obtained by two independent questionnares at baseline (February 2016) and follow-up (February 2018).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Control group: For the 21-month, residents in the control area live as usual.
Interventions/Control_2
Intervention group:For 21-month, a community-wide campaign (distributing walking maps and organizing walking events)is held to promote physical activity in the area.
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
| 65 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Older adults (aged 65-84 years)
Key exclusion criteria
People with disabilities , who report any limitations in activity due to chronic conditions.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Kubota |
Organization
Tokai University
Division name
School of Physical Education
Zip code
Address
4-1-1 Kitakaname, Hiratsuka-shi, Kanagawa
TEL
0463-58-1211
ka092000@tsc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Kubota |
Organization
Tokai University
Division name
School of Physical Education
Zip code
Address
4-1-1 Kitakaname, Hiratsuka-shi, Kanagawa
TEL
0463-58-1211
Homepage URL
ka092000@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
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
| 2018 | Year | 09 | Month | 13 | 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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 13 | Day |
Last modified on
| 2018 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038892
