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
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
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
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
