UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018389 |
|---|---|
| Receipt number | R000021256 |
| Scientific Title | Community-wide promotion of physical activity based on Japanese physical activity guideline in Fujisawa city. |
| Date of disclosure of the study information | 2015/07/23 |
| Last modified on | 2023/01/27 12:05:07 |
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Basic information
Public title
Community-wide promotion of physical activity based on Japanese physical activity guideline in Fujisawa city.
Acronym
Community-wide promotion of physical activity based on Japanese physical activity guideline.
Scientific Title
Community-wide promotion of physical activity based on Japanese physical activity guideline in Fujisawa city.
Scientific Title:Acronym
Community-wide promotion of physical activity based on Japanese physical activity guideline.
Region
| Japan |
Condition
Condition
Physical inactivity
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of community-wide promotion on increasing physical activity among community dwelling people.
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 and two years later for randomly sampled Fujisawa adults.
Key secondary outcomes
Differences in awareness of physical activity guideline and stage of change obtained by two independent questionnares at baseline and two years later for randomly sampled Fujisawa adults.
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 2 year, residents in the control area live as usual.
Interventions/Control_2
Intervention group:For 2 year, a community-wide campaign (information delivery, education delivery, community support delivery)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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling adults living in the area, who is 20 years old or more.
Key exclusion criteria
People with disabilities , who report any limitations in activity due to chronic conditions.
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Oguma |
Organization
Keio University
Division name
Sports Medicine Research Center and Graduate School of Health Management
Zip code
2230061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
0455661090
yoguma@keio.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Oguma |
Organization
Keio University
Division name
Sports Medicine Research Center & Graduate School of Health Management
Zip code
2230061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
045-566-1090
Homepage URL
yoguma@keio.jp
Sponsor or person
Institute
Graduate School of Health Management, Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
City of Fujisawa
Fujisawa City Health and Medical Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Graduate School of Health Management, Keio University
Address
4411 Endo, Fujisawa, Kanagawa
Tel
0466-49-6265
nmc-hm@adst.keio.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
| 2015 | Year | 07 | Month | 23 | Day |
Related information
URL releasing protocol
http://jaee.umin.jp/REE/J/18_2_88.pdf
Publication of results
Partially published
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
| 2013 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021256
