UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029853
Receipt number R000032535
Scientific Title The effectiveness of program to promote physical activity using activity monitor and information and communication technology: a randomized controlled trial
Date of disclosure of the study information 2017/11/07
Last modified on 2022/11/10 09:40:51

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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 or person

Institute

Shimane University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032535


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name