UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052709 |
|---|---|
| Receipt number | R000060146 |
| Scientific Title | Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2026/02/09 21:19:47 |
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Basic information
Public title
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study
Acronym
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study
Scientific Title
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study
Scientific Title:Acronym
Factors for Changes in Alcohol-Related Indicators Due to Non-Alcoholic Beverage Provision in the Workplace: A Pilot Study
Region
| Japan |
Condition
Condition
Excessive drinking that increases the risk of lifestyle-related diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a study investigating the impact of non-alcoholic beverage provision on alcohol consumption levels and identify the various factors that influence drinking behaviors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total alcohol intake for past 3 weeks from baseline (3 weeks after intervention)
Key secondary outcomes
Correlation Between Non-Alcoholic and Alcoholic Beverage Consumption, Total Alcohol Intake, Heavy Drinking Days, Heavy Episodic Drinking, and Binge Drinking Patterns Over Three Weeks
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Provision of non-alcoholic beverages for 3 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Drinkers who drink four days or more a week
2.Drinkers who drink 40g or more for men, 20g or more for women per day
Key exclusion criteria
1.Pregnant / lactating
2.Alcohol dependence syndrome
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Yoshimoto |
Organization
University of Tsukuba
Division name
R&D Center for Lifestyle Innovation
Zip code
305-8550
Address
1-2 Kasuga, Tsukuba 305-8550
TEL
029-853-1019
hisashiyoshi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Ohata |
Organization
University of Tsukuba
Division name
R&D Center for Lifestyle Innovation
Zip code
305-8550
Address
1-2 Kasuga, Tsukuba
TEL
029-853-1019
Homepage URL
lifestyle-tsukuba@un.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, R&D Center for Lifestyle Innovation
Institute
Department
Personal name
Funding Source
Organization
ASAHI BREWERIES, LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba 305-8575
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.cell.com/heliyon/fulltext/S2405-8440(26)00020-4
Publication of results
Published
Result
URL related to results and publications
https://www.cell.com/heliyon/fulltext/S2405-8440(26)00020-4
Number of participants that the trial has enrolled
24
Results
Alcohol consumption was significantly reduced three weeks after the intervention compared to before the intervention (-9.8 g/day, p < 0.01), but this significant reduction in alcohol consumption disappeared six weeks after the intervention (-5.9 g/day, p = 0.057). Non-alcoholic beverage consumption increased three weeks after the intervention (p < 0.01), and this significant increase was maintained even six weeks after the intervention (p < 0.01, Fig. 1B).
Results date posted
| 2026 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 01 | Month | 15 | Day |
Baseline Characteristics
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.
Participant flow
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.
Adverse events
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.
Outcome measures
Our previous study demonstrated that providing three cases of non-alcoholic beverages on separate occasions significantly reduced alcohol consumption among heavy drinkers. However, interventions with reduced costs are required, particularly for health promotion in the workplace. Therefore, we investigated whether a single provision of one case of non-alcoholic beverages could reduce alcohol consumption among workers who drink heavily. This was a single-center, open-label, single-arm study. Participants aged 20 years or older who usually drink heavily but were not diagnosed with alcohol dependence were recruited. Each participant received one case of free non-alcoholic beverages (twenty-four 350 mL cans). From three weeks before to six weeks after the provision of non-alcoholic beverages, the consumption of alcoholic and non-alcoholic beverages was recorded in a drinking diary. Twenty-four individuals participated in this study, one of whom dropped out. Changes in alcohol consumption were analyzed using repeated measures analysis of variance and within-individual associations with non-alcoholic beverage consumption were examined using repeated measures correlation. Alcohol consumption significantly decreased three weeks after the intervention compared to baseline, but this effect was no longer evident at six weeks after the intervention. The reduction in alcohol consumption was associated with the replacement of non-alcoholic beverages without changes in the total intake of alcoholic and non-alcoholic beverages. These findings demonstrate that even a one-time provision of non-alcoholic beverages may be an effective, scalable strategy to reduce alcohol consumption among heavy-drinking workers.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060146
