UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020305 |
|---|---|
| Receipt number | R000023303 |
| Scientific Title | The review of lifestyle works on clinical data related to health |
| Date of disclosure of the study information | 2015/12/22 |
| Last modified on | 2018/07/03 14:25:19 |
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Basic information
Public title
The review of lifestyle works on clinical data related to health
Acronym
The review of lifestyle works on clinical data related to health
Scientific Title
The review of lifestyle works on clinical data related to health
Scientific Title:Acronym
The review of lifestyle works on clinical data related to health
Region
| Japan |
Condition
Condition
metabolic syndrome reserve
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conducted a randomized controlled trial (RCT) to examine the efficacy of reviewing of lifestyle and establishing one's goals for improving life style in pharmacies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight after 6 months from the beginning of intervention
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
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Reviewing of lifestyle
Interventions/Control_2
No intervention
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Person who fulfilled at least of one criteria as follows. BMI >= 25 kg/m2, systolic blood pressure >= 130 mmHg, diastolic blood pressure >= 85 mmHg, fasting blood glucose >= 100 mg/dL, casual blood glucose >= 140 mg/dL, HbA1c >= 5.6%, HDL cholesterol < 40 mg/dL, Triglyceride >= 150 mg/dL, Non-HDL cholesterol >= 150mg/dL
Key exclusion criteria
None
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Suzuki |
Organization
Nagoya City University Graduate School of Pharmaceutical Sciences
Division name
Department of Clinical Pharmacy
Zip code
Address
3-1 Tanabe-dori, Mizuho-ku, Nagoya
TEL
+81-52-836-3616
t-suzuki@phar.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chigusa Kikuchi |
Organization
Nagoya City University Graduate School of Pharmaceutical Sciences
Division name
Department of Clinical Pharmacy
Zip code
Address
3-1 Tanabe-dori, Mizuho-ku, Nagoya
TEL
+81-52-836-3460
Homepage URL
kikuchi@phar.nogoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Aichi Pharmaceutical Association
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 12 | Month | 22 | 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
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 22 | Day |
Last modified on
| 2018 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023303
