UMIN-CTR Clinical Trial

Public title

Effectiveness of digital peer support mobile application for behavior change (Pilot study)

Acronym

Effectiveness of digital peer support mobile application for behavior change

Scientific Title

Pilot study on effectiveness of digital peer support mobile application "minchalle" for behavior change

Scientific Title:Acronym

Pilot study on effectiveness of digital peer support mobile application "minchalle" for behavior change

Region

Japan

Condition

Lifestyle diseases

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effectiveness of digital peer support mobile application "minchalle" for behavior change

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Average footsteps count, proportion of achievement of target daily footsteps

Key secondary outcomes

Lifestyle index(dietary habitat, exercise habitat, sleep. smoking, alcohol intake)
Psychosocial factors(social support, stress, anxiety, solitude and others)
Body index (weight, BMI, somatic fat, blood pressure)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

To use digital peer support mobile application "minchalle" for three months

Interventions/Control_2

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

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

Those who have smartphone and are able to manipulate it

Key exclusion criteria

Those who are unable to make a decision and sign the informed consent document on their own
Those who have difficulty in filling in the questionnaire on their own
Those who face challenging in communication in Japanese
Those who are unable to walk on their own without help
Those who are supposed to have adverse physical or mental effect by the intervention and are regarded inappropriate to be a participant
Those who have a habit of taking regular exercise (doing 30 minute moderate to vigorous exercise a day and twice a week and this habit has lasted more than one year OR doing more than one hour walking or relevant physical exercise everyday)
Those who have experience to participate in ME-BYO living labo projects initiated by Kanagawa Prefecture
Those who have participated in other exercise intervention programs
Those who are ordered by doctors to refrain from exercise
Those who are an expecting mother

Target sample size

50

Name of lead principal investigator

1st name	Hiroto
Middle name
Last name	Narimatsu

Organization

Kanagawa University of Human Services

Division name

Graduate School of Health Innovation

Zip code

210-0821

Address

Research Gate Building TONOMACHI 2-A Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa

TEL

044-589-8100

Email

hiroto-narimatsu@umin.org

Name of contact person

1st name	Narimatsu
Middle name
Last name	Hiroto

Organization

Kanagawa University of Human Services

Division name

Graduate School of Health Innovation

Zip code

210-0821

Address

Research Gate Building TONOMACHI 2-A Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa

TEL

044-589-8100

Homepage URL

Email

hiroto-narimatsu@umin.org

Institute

Kanagawa University of Human Services

Institute

Department

Personal name

Organization

Kanagawa University of Human Services

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Graduate School of Health Innovation, Kanagawa University of Human Services

Address

Research Gate Building TONOMACHI 2-A Tonomachi, Kawasaki-ku, Kawasaki-shi, Kanagawa

Tel

044-589-8100

Email

health-innovation@kuhs.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

2020

Year

11

Month

24

Day

URL releasing protocol

https://www.kuhs.ac.jp/research/ethics_kawasaki/

Publication of results

Unpublished

URL related to results and publications

NA

Number of participants that the trial has enrolled

63

Results

Of the 63 participants who enrolled, 62 completed the intervention. The retention rate was 98% (62/63). The average daily step count during the intervention was 6,993 (standard deviation (SD):2,328), a 1,182 step increase compared to that observed one week before the intervention began.

Results date posted

2023

Year

11

Month

26

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participants from local government offices in Kanagawa, Japan.

Participant flow

Of the 63 participants who enrolled, 62 completed the intervention.

Adverse events

None

Outcome measures

Retention rate and evaluated its feasibility during a three-month intervention period

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2020

Year

10

Month

26

Day

Date of IRB

2020

Year

11

Month

16

Day

Anticipated trial start date

2020

Year

11

Month

27

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

23

Day

Last modified on

2023

Year

11

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048540