UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036544
Receipt number R000041437
Scientific Title Challenge and New Strategy of Health Promotion for Health and Longevity in Okinawa Residents 2: Yui Kenko Project 2
Date of disclosure of the study information 2019/06/30
Last modified on 2019/04/02 09:44:10

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Basic information

Public title

Challenge and New Strategy of Health Promotion for Health and Longevity in Okinawa Residents 2: Yui Kenko Project 2

Acronym

Yui Kenko Project 2

Scientific Title

Challenge and New Strategy of Health Promotion for Health and Longevity in Okinawa Residents 2: Yui Kenko Project 2

Scientific Title:Acronym

Yui Kenko Project 2

Region

Japan


Condition

Condition

Healthy individuals

Classification by specialty

Adult Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Aim of this study is to clarify effect of the information intervention of dietary habits on body weight, nutrition, blood pressure, and physical activity in Okinawa residents.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Change in body weight one year after the information intervention of dietary habits in participants with or without obesity

Key secondary outcomes

1) Change in body mass index in participants with or without obesity
2) Change in salt intake
3) Change in vegetable intake
4) Change in blood pressure
5) Change in physical activity
6) Change in health checkup rate and laboratory parameters
7) Association between primary outcomes and socio-economic factors
8) Association between secondary outcomes (2 - 6) and socio-economic factors
9) Association between baseline characteristics and socio-economic factors
10) Nutrition survey and body weight in elementary school children


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

nutrition survey and information intervention of dietary habit

Interventions/Control_2

health education

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

6 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. healthy elementary school parents in Okinawa prefecture, Japan
2. elementary school children in Okinawa prefecture, Japan

Key exclusion criteria

1. the patient treated with potassium restriction therapy
2. the patient with malignant diseases or connective tissue diseases
3. the patient with acute stroke or acute myocardial infarction within 6 months
4. the patient with past history of cancer within 5 years
5. patient with heart failure (NYHA II and over)
6. the patient with liver damage (ALT more than 100 IU/Land/or AST more than 100 IU/L)
7. the patient with chronic kidney disease (serum Cr 3.0 mg/dl and over)
8. the patient treated with insulin therapy
9. the patient who was excluded by the medical decision of the investigators

Target sample size

5000


Research contact person

Name of lead principal investigator

1st name Yusuke
Middle name
Last name Ohya

Organization

Graduate School of Medicine, University of the Ryukyus

Division name

Department of Cardiovascular Medicine, Nephrology and Neurology

Zip code

903-0215

Address

207 Uehara, Nishihara-cho, Okinawa, Japan

TEL

098-895-1150

Email

3naika-crc@w3.u-ryukyu.ac.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Ohya

Organization

Graduate School of Medicine, University of the Ryukyus

Division name

Department of Cardiovascular Medicine, Nephrology and Neurology

Zip code

903-0215

Address

207 Uehara, Nishihara-cho, Okinawa, Japan

TEL

098-895-1150

Homepage URL


Email

3naika-crc@w3.u-ryukyu.ac.jp


Sponsor or person

Institute

University of the Ryukyus

Institute

Department

Personal name



Funding Source

Organization

Okinawa Prefecture

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

University of the Ryukyus

Address

1 Senbaru, Nishihara-cho, Okinawa, Japan

Tel

098-895-8016

Email

nknkyu@to.jim.u-ryukyu.ac.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

2019 Year 06 Month 30 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

12374

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

No longer recruiting

Date of protocol fixation

2013 Year 06 Month 19 Day

Date of IRB

2013 Year 06 Month 19 Day

Anticipated trial start date

2013 Year 06 Month 19 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 19 Day

Last modified on

2019 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041437


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name