UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026837 |
|---|---|
| Receipt number | R000030761 |
| Scientific Title | Effects of physical and nutrition instruction for community dwelling people with risk of metabolic syndrome. |
| Date of disclosure of the study information | 2017/04/03 |
| Last modified on | 2022/10/07 09:55:51 |
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Basic information
Public title
Effects of physical and nutrition instruction for community dwelling people with risk of metabolic syndrome.
Acronym
Physical and nutrition instruction for people with risk of metabolic syndrome.
Scientific Title
Effects of physical and nutrition instruction for community dwelling people with risk of metabolic syndrome.
Scientific Title:Acronym
Physical and nutrition instruction for people with risk of metabolic syndrome.
Region
| Japan |
Condition
Condition
People with risk of metabolic syndrome
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate how physical and nutrition instruction affect risk of metabolic syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in outcomes as follows during health examinations for the intervention start year and health examinations after one year.
Body weight, hematologic test
Key secondary outcomes
Dietary habit, food consciousness
Step count, physical activity amount
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
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
Periodic assessment and follow up of physical activity amounts, motor function, dietary habits, and food consciousness.
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Community dwelling people who will be extracted as target of specific health guidance by annual specific health examination carried out by local government.
Key exclusion criteria
People who have already received periodic follow up and medication by diabetes mellitus, hyperlipidemia, hyper blood pressure.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanaka Shigeya |
Organization
Takasaki Univesity of Health and Welfare
Division name
Department of Psysical therapy, Faculty of Health care
Zip code
Address
501 Nakaoruicho, Takasaki City, Gunma
TEL
027-352-1291
tanaka-s@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tanaka Shigeya |
Organization
Takasaki Univesity of Health and Welfare
Division name
Department of Psysical therapy, Faculty of Health care
Zip code
Address
501 Nakaoruicho, Takasaki City, Gunma
TEL
027-352-1291
Homepage URL
tanaka-s@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Wealfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
2853
Org. issuing International ID_1
Takasaki University of Health and Wealfare
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 03 | 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
50
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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 03 | Day |
Last modified on
| 2022 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030761
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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