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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036544
Receipt No. 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

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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
Institute University of the Ryukyus
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 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
URL(English) https://upload.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


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