UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013581
Receipt number R000015868
Scientific Title Risk-strategy in preventive medicine in Takahata
Date of disclosure of the study information 2014/04/01
Last modified on 2024/03/01 13:28:51

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Basic information

Public title

Risk-strategy in preventive medicine in Takahata

Acronym

Takahata "GENKI" project

Scientific Title

Risk-strategy in preventive medicine in Takahata

Scientific Title:Acronym

Takahata "GENKI" project

Region

Japan


Condition

Condition

Obesity

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficasy of the intervention based on the risk strategy in preventive medicine

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

body mass index

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Intensive education on life habits

Interventions/Control_2

Control

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

40 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

BMI is equal or more than 25.
eGFR is less than 90.
People who underwent the screening by the Takahata city.

Key exclusion criteria

None

Target sample size

83


Research contact person

Name of lead principal investigator

1st name Hiroto
Middle name
Last name NARIMATSU

Organization

Kanagawa Cancer Center Research Institute

Division name

Cancer Prevention and Control Division

Zip code

241-8515

Address

2-2-2 Nakao, Asahi-ku,Yokohama, 241-8515

TEL

045-520-2222

Email

hiroto-narimatsu@umin.org


Public contact

Name of contact person

1st name Hiroto
Middle name
Last name NARIMATSU

Organization

Kanagawa Cancer Center Research Institute

Division name

Cancer Prevention and Control Division

Zip code

241-8515

Address

2-2-2 Nakao, Asahi-ku,Yokohama, 241-8515

TEL

045-520-2222

Homepage URL


Email

hiroto-narimatsu@umin.org


Sponsor or person

Institute

Cancer Prevention and Control Division
Kanagawa Cancer Center Research Institute

Institute

Department

Personal name



Funding Source

Organization

Takahata city

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kanagawa Cancer Center

Address

2-2-2 Nakao Asahi-ku Yokohama

Tel

045-520-2222

Email

chiken-jimu4@kcch.jp


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

2014 Year 04 Month 01 Day


Related information

URL releasing protocol

https://www.dovepress.com/getfile.php?fileID=73810

Publication of results

Published


Result

URL related to results and publications

https://www.dovepress.com/getfile.php?fileID=73810

Number of participants that the trial has enrolled

195

Results

After one year, neither BMI nor eGFR differed significantly between groups. However, after three years, the BMI in the intervention group was significantly reduced compared to that in the control group.

Results date posted

2024 Year 03 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 09 Month 04 Day

Baseline Characteristics

Residents in the high-risk group based on the results of health check-ups conducted in 2014

Participant flow

In this study, we recruited 195 patients, of whom 117 were assigned to the control group and 78 to the intervention group.

Adverse events

Not reported

Outcome measures

BMI after one year

Plan to share IPD

not applicable

IPD sharing Plan description

not applicable


Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 03 Month 05 Day

Date of IRB

2014 Year 02 Month 17 Day

Anticipated trial start date

2014 Year 04 Month 21 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 03 Month 31 Day

Last modified on

2024 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015868


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name