UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045025 |
|---|---|
| Receipt number | R000051128 |
| Scientific Title | The effect of personalized normative feedback on alcohol consumption of middle-aged or older adults |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2024/02/01 22:08:44 |
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Basic information
Public title
The effect of personalized normative feedback on alcohol consumption of middle-aged or older adults
Acronym
The effect of personalized normative feedback on alcohol consumption of middle-aged or older adults
Scientific Title
The effect of personalized normative feedback on alcohol consumption of middle-aged or older adults
Scientific Title:Acronym
The effect of personalized normative feedback on alcohol consumption of middle-aged or older adults
Region
| Japan |
Condition
Condition
Heavy drinkers
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of personalized normative feedback on alcohol consumption of middle-aged or older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in average alcohol consumption per day between baseline and week4
Key secondary outcomes
Change in alcohol use disorders identification test (AUDIT) between baseline and week4
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Personalized normative feedback to drinking behavior at baseline
Interventions/Control_2
Usual feedback to drinking behavior at baseline
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
those who have taken the specific health checkup
those who drink every day or sometimes
those who drink >= 6 drinks on a usual drinking day
Key exclusion criteria
nothing
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Ryuhei |
| Middle name | |
| Last name | So |
Organization
Okayama Psychiatric Medical Center
Division name
Division of Clinical Research
Zip code
700-0915
Address
Shikata-honmachi 3-16, Kita-ku, Okayama-shi, Okayama-ken
TEL
086-225-3821
nexttext@gmail.com
Public contact
Name of contact person
| 1st name | Ryuhei |
| Middle name | |
| Last name | So |
Organization
Okayama Psychiatric Medical Center
Division name
Division of Clinical Research
Zip code
700-0915
Address
Shikata-honmachi 3-16, Kita-ku, Okayama-shi, Okayama-ken
TEL
086-225-3821
Homepage URL
nexttext@gmail.com
Sponsor or person
Institute
Okayama Psychiatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
Masason Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Psychiatric Medical Center Institutional Review Board
Address
Shikata-honmachi 3-16, Kita-ku, Okayama-shi, Okayama-ken
Tel
086-225-3821
nexttext@gmail.com
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
| 2021 | Year | 07 | Month | 31 | 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
730
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
Terminated
Date of protocol fixation
| 2021 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051128
