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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034114
Receipt No. 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

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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
Email 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
Email ka092000@tsc.u-tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038892

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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