UMIN-CTR Clinical Trial

Basic information
Public title	Challenge and New Strategy of Health Promotion for Health and Longevity in Okinawa Residents: Yui Kenko Project
Acronym	Yui Kenko Project
Scientific Title	Challenge and New Strategy of Health Promotion for Health and Longevity in Okinawa Residents: Yui Kenko Project
Scientific Title:Acronym	Yui Kenko Project
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	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	annual nutrition survey and information intervention of dietary habit
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

Eligibility
Age-lower limit	6 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. healthy local residents or 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	10000

Research contact person
Last 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
1st 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
Institute	Graduate School of Medicine, University of the Ryukyus Department of Cardiovascular Medicine, Nephrology and Neurology
Institute
Department

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	knknkyu@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	3559
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041374