UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a population strategy for promoting physical activity in local community.
Title of the study (Brief title)	A population strategy for promoting physical activity.
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 adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differences in physical activity obtained by two independent questionnares at baseline (March 2013) and follow-up (January 2015).
Key secondary outcomes

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 18-month, residents in the control area live as usual.
Interventions/Control_2	Intervention group:For 18-month, a community-wide campaign 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	30 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	Adult residents (aged 30-74 years)
Key exclusion criteria	People with disabilities , who report any limitations in activity due to chronic conditions.
Target sample size	6400

Research contact person
Name of lead principal investigator	Takashi Arao
Organization	Meiji Yasuda Life Foundation of Health and Welfare
Division name	Physical Fitness Research Institute
Address	150 Tobukimachi, Hachiouji, Tokyo
TEL	042-691-1163
Email	tarao@waseda.jp

Public contact
Name of contact person	Akio Kubota
Organization	Tokai University
Division name	School of Physical Education
Address	4-1-1 Kitakaname, Hiratsuka-shi, Kanagawa
TEL	0463-58-1211
Homepage URL
Email	ka092000@tsc.u-tokai.ac.jp

Sponsor
Institute	Waseda 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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 05 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	https://doi.org/10.14838/jjls.11.43
Publication of results	Unpublished
URL releasing results
Results
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=R000038893