UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of vibrotactile feedback on sedentary behaviors: a pilot randomized controlled trial
Title of the study (Brief title)	Vibrotactile feedback to reduce sedentary behaviors
Region	Japan

Condition
Condition	Healthy but sedentary population
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether vibrotactile feedback can reduce sedentary time in previously sedentary adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sedentary time (change from baseline to the intervention period)
Key secondary outcomes	Changes from baseline to the intervention period for the following outcomes; -Transitions from sitting/lying to standing -Light-intensity physical activity -Moderate-to-vigorous physical activity -Step counts Changes from baseline to week 8 for the following outcomes; -Sedentary time -Transitions from sitting/lying to standing -Light-intensity physical activity -Moderate-to-vigorous physical activity -Step counts -Body weight -Abdominal visceral fat level -Pulse wave velocity -Central arterial pressure -Vascular endothelial function

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Assessment of sedentary behavior plus feedback program using spontaneous vibration and a weekly report
Interventions/Control_2	Assessment of sedentary behavior only
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Self-reported sedentary time is 8 hours per day or longer
Key exclusion criteria	1. Pregnant or trying to get pregnant during the study period. 2. Irregular working conditions such as night/shift work. 3. Scheduled to disturb life rhythm such as an extended business trip during the study period. 4. Current participation or intention to participate in other clinical trials. 5. Considered ineligible judged by the principal investigator.
Target sample size	32

Research contact person
Name of lead principal investigator	Seiji Maeda
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-8859
Email	maeda@taiiku.tsukuba.ac.jp

Public contact
Name of contact person	Hiroyuki Sasai
Organization	University of Tsukuba
Division name	Faculty of Medicine
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3076
Homepage URL
Email	hiroyuki.sasai@gmail.com

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	筑波大学総合研究棟D

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 03 Day
Anticipated trial start date	2016 Year 10 Month 14 Day
Last follow-up date	2016 Year 12 Month 25 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 05 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 12 Day
Last modified on	2018 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028056