UMIN-CTR Clinical Trial

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
Email	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
Email	tsujimoto@hmn.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032535