UMIN-ICDS Clinical Trial

Public title

An Empirical Study on the Prevention of Social Isolation and Loneliness among Middle-aged and Older Men

Acronym

Social Isolation and Loneliness among Middle-aged and Older Men

Scientific Title

An Empirical Study on the Prevention of Social Isolation and Loneliness among Middle-aged and Older Men

Scientific Title:Acronym

Social Isolation and Loneliness among Middle-aged and Older Men

Region

Japan

Condition

Healthy older people or older people with mild frailty who live in community

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This project aims to implement Men's Shed, a community space for men, in Japan. The purpose of this study is to verify whether the Men's Shed functions effectively as a primary prevention system for social isolation and loneliness among middle-aged and older men, and whether it has a positive impact on their health, based on field investigations and psychological, brain, and health examinations.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Mental functioning (loneliness, depression), social identity, and participation in activities at one and two years after the intervention

Key secondary outcomes

Health status, cognitive function, subjective well-being, brain structure, and brain function at one and two years after the intervention

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Other

Interventions/Control_1

Participants in the intervention group belong to and participate in a Men's shed, which is a social activity in their community. In the Men's Shed, members gather in their own "base (shed)" and engage in a variety of activities according to their preferences, skills, and environment. They divide and manage their own roles. Participants can decide how often and when they want to participate in the shed according to their own availability and preferences. The duration of the program is two years.

Interventions/Control_2

Participants in the control group participate in local social activities outside of the Men's Shed. Participants can decide the type of social activities, frequency, and time of participation according to their convenience and preference. However, the type of social activities depends on the social resources in the community where the participants live. The duration of the program is two years.

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

50

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

Those who
- live in the suburbs of Sapporo
- can speak daily conversation
- can communicate in Japanese

Key exclusion criteria

Hospitalized patients

Target sample size

110

Name of lead principal investigator

1st name	Risa
Middle name
Last name	Takashima

Organization

Hokkaido University

Division name

Department of Rehabilitation Science, Faculty of Health Sciences

Zip code

0600812

Address

Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan

TEL

011-706-3380

Email

risa-t@hs.hokudai.ac.jp

Name of contact person

1st name	Risa
Middle name
Last name	Takashima

Organization

Hokkaido University

Division name

Department of Rehabilitation Science, Faculty of Health Sciences

Zip code

0600812

Address

Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan

TEL

011-706-3380

Homepage URL

Email

risa-t@hs.hokudai.ac.jp

Institute

Hokkaido University

Institute

Department

Personal name

Risa Takashima

Organization

Japan Science and Technology Agency (JST)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Expert committee of faculty of health sciences of Hokkaido university

Address

Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-0812, Japan

Tel

011-706-3316

Email

shomu@hs.hokudai.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

地域の会館や施設等（Public halls and facilities in community）

Date of disclosure of the study information

2023

Year

12

Month

15

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

15

Day

Date of IRB

Anticipated trial start date

2024

Year

01

Month

15

Day

Last follow-up date

2027

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

12

Month

14

Day

Last modified on

2023

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060598