UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010809 |
|---|---|
| Receipt number | R000012541 |
| Scientific Title | Tenshi Health and Nutrition Clinic - Prevention and Alleviation Effects on Metabolic Syndrome - |
| Date of disclosure of the study information | 2013/05/27 |
| Last modified on | 2022/12/05 12:24:01 |
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Basic information
Public title
Tenshi Health and Nutrition Clinic - Prevention and Alleviation Effects on Metabolic Syndrome -
Acronym
Tenshi Health and Nutrition Clinic - Prevention and Alleviation Effects on Metabolic Syndrome -
Scientific Title
Tenshi Health and Nutrition Clinic - Prevention and Alleviation Effects on Metabolic Syndrome -
Scientific Title:Acronym
Tenshi Health and Nutrition Clinic - Prevention and Alleviation Effects on Metabolic Syndrome -
Region
| Japan |
Condition
Condition
Men and women aged 40 and over without a critical disease
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare groups which received intervention for eating behaviors physical activity and rest versus the control group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The stage of change in exercise behavior, self efficacy (SE), social support (SS) scores, physical fitness, body composition, blood test results and nutrient intake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Measurement of body size and blood pressure, blood collection (biochemical analysis), dietary survey and lifestyle survey.
The same investigation is conducted in three months.
Interventions/Control_2
The intervention group received both group and individual support about eating behaviors, and physical activity and rest 6 times in three months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy male and female volunteers
2. Aged 40 and over
3. Be able to provide written informed consent
Key exclusion criteria
with a critical disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Musashi |
Organization
Tenshi College
Division name
School of Nursing and Nutrition
Zip code
0650013
Address
Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL
011-741-1051
musashi@tenshi.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Musashi |
Organization
Tenshi College
Division name
School of Nursing and Nutrition
Zip code
0650013
Address
Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL
011-741-1051
Homepage URL
http://clinic.tenshidaigaku.net/
musashi@tenshi.ac.jp
Sponsor or person
Institute
Tenshi College, School of Nursing and Nutrition, Department of Nutrition
Institute
Department
Personal name
Funding Source
Organization
Special Research Grant of Tenshi College
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
Tenshi College
Address
Kita 13-jo Higashi 3-chome 1-30, Higashi-ku, Sapporo, Hokkaido
Tel
011-741-1051
kenkyurinri@tenshi.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
天使大学（北海道） Tenshi College (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 27 | 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
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
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012541
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
