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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000017740 |
Receipt No. | R000016818 |
Scientific Title | Observational study and intervention study for alcohol related problems in Japanese rural populations. |
Date of disclosure of the study information | 2015/06/01 |
Last modified on | 2017/09/13 |
Basic information | ||
Public title | Observational study and intervention study for alcohol related problems in Japanese rural populations. | |
Acronym | Observational study and intervention study for alcohol related problems in Japanese rural populations. | |
Scientific Title | Observational study and intervention study for alcohol related problems in Japanese rural populations. | |
Scientific Title:Acronym | Observational study and intervention study for alcohol related problems in Japanese rural populations. | |
Region |
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Condition | |||
Condition | metabolic syndrome | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to examine the effecacy of intervention for alcohol intake in communities. We will cooperate with local governments. We will use AUDIT and brief intervention method. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Body weight, waist circumference, score of AUDIT, blood pressure levels and blood tests (serum fatty acids, blood glucose, HbA1c and hepatic enzymes) |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Non-randomized |
Randomization unit | |
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 |
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Interventions/Control_1 | (Intervention group)Do brief intervention for alcohol intake in addition to ordinary health education to control metabolic syndrome. | |
Interventions/Control_2 | (Control group)Do ordinary health education to control metabolic syndrome. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Subjects who met all criterias below.
1. Diagnosed with metabolic syndrome by health check-up 2. Point out excess of low-risk alcohol intake by AUDIT 3. Agreed with the protocol of this study. |
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Key exclusion criteria | Subjects who did not meet criterias.
1. Diagnosed with metabolic syndrome by health check-up 2. Point out excess of low-risk alcohol intake by AUDIT 3. Agreed with the protocol of this study. |
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Target sample size | 180 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Dokkyo Medical University, School of Medicine | ||||||
Division name | Department of Public Health | ||||||
Zip code | |||||||
Address | 880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi, Japan | ||||||
TEL | 0282-87-2133 | ||||||
starlight-shower@nifty.com |
Public contact | |||||||
Name of contact person |
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Organization | Dokkyo Medical University, School of Medicine | ||||||
Division name | Department of Public Health | ||||||
Zip code | |||||||
Address | 880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi, Japan | ||||||
TEL | 0282-87-2133 | ||||||
Homepage URL | |||||||
starlight-shower@nifty.com |
Sponsor | |
Institute | Department of Public Health, Dokkyo Medical University, School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Health, Labour and Welfare |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
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 | 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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://mhlw-grants.niph.go.jp/index.html |
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 | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Research reports are released at the MHLW GRANTS SYSTEM. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016818 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |