UMIN-ICDS Clinical Trial

Public title

Development of an online lifestyle improvement program aimed at improving the motor function of telework workers

Acronym

Development of an online lifestyle improvement program aimed at improving the motor function of telework workers

Scientific Title

Development of an online lifestyle improvement program aimed at improving motor function of telework workers: Cluster RCT

Scientific Title:Acronym

Development of an online lifestyle improvement program aimed at improving motor function of telework workers: Cluster RCT

Region

Japan

Condition

Not applicable

Classification by specialty

Nursing	Not applicable	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study was to use an 8-week online health education program for telework workers in their 30s to 50s to improve their lifestyle habits, promote physical activity, and improve motor function during telework. The purpose of this study was to conduct a cluster randomized controlled trial to verify the effectiveness of a program with step length as the primary endpoint.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

maximum stride length

Key secondary outcomes

Physical activity level, CS-30, toe grip strength

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Group A will be the intervention group and Group B will be the control group.
Intervention: Implement an 8-week online health education program to improve motor function for teleworkers.

Interventions/Control_2

Control: Group B will undergo an equivalent program after completing the program of Group A.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Research target business establishment
Businesses that meet all of the following conditions are targeted.
1) The selection criteria for establishments is that each department has at least 10 male and female workers between the ages of 30 and 59 engaged in telework.
2) A department to which regular employees in the same or similar industry belong.
3) A person in charge of this research will be assigned in the department and will be able to respond to intervention programs for research subjects and the workplace.

2. Research subjects
Persons who meet all of the following conditions in departments that meet the requirements for research target business establishments will be targeted.
1) Regular male and female employees aged 30 to 59 engaged in telework
2) You can access the Internet by yourself to watch videos and respond to web surveys.
3) Possible to conduct and participate in physical measurements and physical fitness measurements
4) Those who have given their free written consent after receiving sufficient explanation and understanding to participate in this research.

Key exclusion criteria

1) Those who have been hospitalized or had surgery for orthopedic disease within the past 3 months
2) Persons participating in other health-related programs
3) Any other person who is judged by the research director (co-partner) to be inappropriate as a research subject.

Target sample size

120

Name of lead principal investigator

1st name	Rumi
Middle name
Last name	Tsukinoki

Organization

Tokyo Medical and Dental University

Division name

Graduate School of Health Care Sciences

Zip code

113-8519

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5350

Email

r-tsukinoki.phn@tmd.ac.jp

Name of contact person

1st name	Tomoko
Middle name
Last name	Shiomitsu

Organization

Tokyo Medical and Dental University

Division name

Graduate School of Health Care Sciences

Zip code

113-8519

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

03-5803-5350

Homepage URL

Email

ns173001@tmd.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Nomura Real Estate Holdings, Inc

Organization

Faculty of Medicine Research Ethics Committee, Tokyo Medical and Dental University

Address

113-8519 1-5-45 Yushima, Bunkyo-ku, Tokyo

Tel

03-5803-5096

Email

syomu1.adm@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

01

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

12

Month

31

Day

Date of IRB

Anticipated trial start date

2024

Year

01

Month

01

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

10

Month

06

Day

Last modified on

2023

Year

10

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059838