Alcohol DrinkingNCT05779774
WayToServePlus: Improving Responsible Alcohol Service Ph II
A study testing WayToServe Plus In-service Component and WayToServe Training Only in people with Alcohol Drinking and Alcohol Intoxication, run by Klein Buendel, Inc. at 1 site in United States.
Trial summary
Responsible beverage service (RBS) training for alcohol servers is a promising intervention for reducing driving while intoxicated (DWI) by alcohol. Training, certification, and in-service contact improves professionalism and effectiveness of prevention interventions delivered by community members such as alcohol… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Intoxication, Alcohol Use, Unspecified
- What is being tested?
- WayToServe Plus In-service Component and WayToServe Training Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 years of age or older
- Own/manage a licensed premises or be an alcohol server (waitress, waiter or bartender)
- Have completed the WayToServe responsible beverage service training (Phase I only)
- Be proficient in English
- Consent to participate
Who cannot join
- Have a family/household member already participating in project • Younger than 19 years old (18 and younger cannot legally serve alcohol in either state)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WayToServe Plus: In-service Professional Development Component to Improve Responsible Alcohol Service Ph II
Responsible beverage service (RBS) training for alcohol servers is a promising intervention for reducing driving while intoxicated (DWI) by alcohol. Training, certification, and in-service contact improves professionalism and effectiveness of prevention interventions delivered by community members such as alcohol servers. This SBIR Fast-track project will develop and test an in-service professional development component to the WayToServe® online RBS training to improve the effectiveness of RBS training in order to make further gains in reducing problem alcohol behavior in communities.
Read the detailed description
Among the interventions targeting driving while intoxicated (DWI) by alcohol, Responsible Beverage Service (RBS) training of alcohol servers has shown promise. RBS training is currently required or incentivized by 36 U.S. states and California will require it starting in 2022. The research team has shown that an online RBS training, named WayToServe®, was effective in two randomized trials. These results filled a gap in the literature on RBS training that is limited by the lack of randomized trials, poor measurement of training implementation, and almost exclusive focus on live training when online training predominates. The goal of this SBIR Fast-track research is to develop and test an in-service professional development component for alcohol servers trained by WayToServe to improve its effectiveness. It is intended to motivate servers to implement the RBS skills in the face of common barriers, provide support for RBS actions from a "community" of alcohol servers, and prevent natural degradation of skills over time. Rationale for this product is provided by past research showing that training, certification, and in-service contact improves professionalism and efficacy of community prevention interventions. Scientific premise is provided by the positive results of our trials on the WayToServe® training. The in-service component will be delivered through the WayToServe Facebook page that currently is "followed" by over 20,000 alcohol servers trained by WayToServe. The specific aims of Phase I are to: 1) develop content of in-service professional development on RBS skills with a) premises owners/ managers interviews and b) alcohol servers in New Mexico and Washington State trained by the WayToServe online RBS training through focus group discussions; 2) produce a prototype WayToServe Plus in-service professional development component in flowcharts and an initial library of Facebook posts, including text, graphics, and interactive elements and evaluate it for acceptability, usability, and engagement in focus groups and field pilot trial with alcohol servers in New Mexico and Washington State trained by the WayToServe online RBS training, and 3) determine feasibility of WayToServe Plus in-service professional development component and develop evaluation plans for Phase II research. Milestones will be an EAB-approved Phase I research plans and development of the content outline and WayToServe Plus prototype, evaluation of WayToServe Plus prototype, and feasibility assessment of the WayToServe Plus in-service professional development component. Phase II specific aims will achieve the milestones of full production of WayToServe Plus and a randomized trial testing its effectiveness by: 4) producing the full WayToServe Plus in-service professional development component and 5) conducting a randomized trial with 160 alcohol premises in New Mexico and Washington State evaluating effectiveness of WayToServe Plus on refusal of sales to PiP (primary outcome). The SBIR research is innovative as WayToServe Plus will be the first continuous in-service professional development for RBS and will increase the WayToServe training's effectiveness and commercial advantage with alcohol servers and corporate clients.
- Being tested
- WayToServe Plus In-service Component, WayToServe Training Only
- Keywords
- Alcohol service, Driving under influence, DWI prevention, Safe alcohol service
- Medical subject headings
- Alcohol Drinking, Alcoholic Intoxication, Driving Under the Influence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WayToServe Plus In-service ComponentBehavioural
Investigators will test WayToServe Plus in-service component's ability to increase refusal of service to intoxicated patrons in a randomized trial. A two-group randomized field trial (WayToServe training only [comparison control] v. WayToServe training plus WayToServe Plus in-service component [intervention]) with 2 assessment rounds (Baseline, Posttest) will yield a 2 factorial design. Investigators will randomly assign premises to WayToServe training and WayToServe Plus after baseline in Month 18, stratified by state and location. Remaining premises will receive WayToServe Training Only. All premises will be recruited to have servers complete WayToServe training. Servers in intervention group will be accepted into a Facebook private group after WayToServe training to receive in-service component with ~3 posts per week for 12 months. In Months 30-32, all premises will be posttested with PiP assessments (blind to condition).
WayToServe Training OnlyBehavioural
Investigators will test WayToServe Plus in-service component's ability to increase refusal of service to intoxicated patrons in a randomized trial. A two-group randomized field trial (WayToServe Training Only [comparison control] v. WayToServe Plus In-service Component [intervention]) with 2 assessment rounds (Baseline, Posttest) will yield a 2 factorial design. Investigators will randomly assign premises to WayToServe Traiing Only after baseline in Month 18, stratified by state and location. In Months 30-32, all premises will be posttested with PiP assessments (blind to condition).
| Study group | Role | What they receive |
|---|---|---|
| WayToServe Plus In-service Component | Experimental | Intervention group of servers to participate in Facebook group. Receives: Behavioral: WayToServe Plus In-service Component |
| WayToServe Training Only | Experimental | Control group of servers who do not participate in Facebook group and receive WayToServe Training only. Receives: Behavioral: WayToServe Training Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refusal rate of alcohol service to apparently-intoxicated patrons
Primary outcome measure, refusal rate of alcohol service to apparently-intoxicated patrons, will be obtained via a pseudo-intoxicated patron (PiP) assessment. Confederate buyers will feign intoxication and record if servers agree to serve them an alcoholic beverage. PiP protocol presents a server with the most overt situation in which alcohol service should be refused, (i.e., when a patron is showing clear signs of intoxication), models behavior of patrons most at risk, and is relatively low cost.
Measured: Change in refusal rate between baseline and 1 year posttest assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Oct 2022
- Primary completion1 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Pacific Institute for Research and Evaluation
- Responsible party
- Sponsor
- Investigators
- David Buller, PhD, Principal investigator, Klein Buendel, Inc.Gill Woodall, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779774
- Sponsor's protocol ID
- 0338
- Other IDs
- 4R44AA029364-02
- Status last verified
- Oct 2026
- First submitted
- 7 Feb 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Woodall WG, Buller D, Saltz R, Martinez L. Professional Development to Improve Responsible Beverage Service Training: Formative Research Results and Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jan 24;13:e49680. doi: 10.2196/49680.
PubMed 38265847Buller DB, Woodall GW, Saltz R, Martinez L, Small A, Chirico N, Cutter GR. Sales to Apparently Intoxicated Customers in Three States With Different Histories of Responsible Beverage Service Training. J Stud Alcohol Drugs. 2024 May;85(3):312-321. doi: 10.15288/jsad.23-00258. Epub 2024 Jan 16.
PubMed 38227392
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WayToServe Plus: In-service Professional Development Component to Improve Responsible Alcohol Service Ph II
- ClinicalTrials.gov ID
- NCT05779774
- Acronym / sponsor ID
- 0338
- Keywords
- Alcohol service, Driving under influence, DWI prevention, Safe alcohol service
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Pacific Institute for Research and Evaluation
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Responsible beverage service (RBS) training for alcohol servers is a promising intervention for reducing driving while intoxicated (DWI) by alcohol. Training, certification, and in-service contact improves professionalism and effectiveness of prevention interventions delivered by community members such as alcohol servers. This SBIR Fast-track project will develop and test an in-service professional development component to the WayToServe® online RBS training to improve the effectiveness of RBS training in order to make further gains in reducing problem alcohol behavior in communities.
Detailed description
Among the interventions targeting driving while intoxicated (DWI) by alcohol, Responsible Beverage Service (RBS) training of alcohol servers has shown promise. RBS training is currently required or incentivized by 36 U.S. states and California will require it starting in 2022. The research team has shown that an online RBS training, named WayToServe®, was effective in two randomized trials. These results filled a gap in the literature on RBS training that is limited by the lack of randomized trials, poor measurement of training implementation, and almost exclusive focus on live training when online training predominates. The goal of this SBIR Fast-track research is to develop and test an in-service professional development component for alcohol servers trained by WayToServe to improve its effectiveness. It is intended to motivate servers to implement the RBS skills in the face of common barriers, provide support for RBS actions from a "community" of alcohol servers, and prevent natural degradation of skills over time. Rationale for this product is provided by past research showing that training, certification, and in-service contact improves professionalism and efficacy of community prevention interventions. Scientific premise is provided by the positive results of our trials on the WayToServe® training. The in-service component will be delivered through the WayToServe Facebook page that currently is "followed" by over 20,000 alcohol servers trained by WayToServe. The specific aims of Phase I are to: 1) develop content of in-service professional development on RBS skills with a) premises owners/ managers interviews and b) alcohol servers in New Mexico and Washington State trained by the WayToServe online RBS training through focus group discussions; 2) produce a prototype WayToServe Plus in-service professional development component in flowcharts and an initial library of Facebook posts, including text, graphics, and interactive elements and evaluate it for acceptability, usability, and engagement in focus groups and field pilot trial with alcohol servers in New Mexico and Washington State trained by the WayToServe online RBS training, and 3) determine feasibility of WayToServe Plus in-service professional development component and develop evaluation plans for Phase II research. Milestones will be an EAB-approved Phase I research plans and development of the content outline and WayToServe Plus prototype, evaluation of WayToServe Plus prototype, and feasibility assessment of the WayToServe Plus in-service professional development component. Phase II specific aims will achieve the milestones of full production of WayToServe Plus and a randomized trial testing its effectiveness by: 4) producing the full WayToServe Plus in-service professional development component and 5) conducting a randomized trial with 160 alcohol premises in New Mexico and Washington State evaluating effectiveness of WayToServe Plus on refusal of sales to PiP (primary outcome). The SBIR research is innovative as WayToServe Plus will be the first continuous in-service professional development for RBS and will increase the WayToServe training's effectiveness and commercial advantage with alcohol servers and corporate clients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WayToServe Plus In-service Component | Experimental | Behavioral: WayToServe Plus In-service ComponentIntervention group of servers to participate in Facebook group. |
| WayToServe Training Only | Experimental | Behavioral: WayToServe Training OnlyControl group of servers who do not participate in Facebook group and receive WayToServe Training only. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 19 years of age or older
- Own/manage a licensed premises or be an alcohol server (waitress, waiter or bartender)
- Have completed the WayToServe responsible beverage service training (Phase I only)
- Be proficient in English
- Consent to participate
Key exclusion criteria (1 listed)
- Have a family/household member already participating in project • Younger than 19 years old (18 and younger cannot legally serve alcohol in either state)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WayToServe Plus In-service ComponentInvestigators will test WayToServe Plus in-service component's ability to increase refusal of service to intoxicated patrons in a randomized trial. A two-group randomized field trial (WayToServe training only [comparison control] v. WayToServe training plus WayToServe Plus in-service component [intervention]) with 2 assessment rounds (Baseline, Posttest) will yield a 2 factorial design. Investigators will randomly assign premises to WayToServe training and WayToServe Plus after baseline in Month 18, stratified by state and location. Remaining premises will receive WayToServe Training Only. All premises will be recruited to have servers complete WayToServe training. Servers in intervention group will be accepted into a Facebook private group after WayToServe training to receive in-service component with ~3 posts per week for 12 months. In Months 30-32, all premises will be posttested with PiP assessments (blind to condition). | Behavioural | WayToServe Plus In-service Component |
| WayToServe Training OnlyInvestigators will test WayToServe Plus in-service component's ability to increase refusal of service to intoxicated patrons in a randomized trial. A two-group randomized field trial (WayToServe Training Only [comparison control] v. WayToServe Plus In-service Component [intervention]) with 2 assessment rounds (Baseline, Posttest) will yield a 2 factorial design. Investigators will randomly assign premises to WayToServe Traiing Only after baseline in Month 18, stratified by state and location. In Months 30-32, all premises will be posttested with PiP assessments (blind to condition). | Behavioural | WayToServe Training Only |
Primary outcome
Refusal rate of alcohol service to apparently-intoxicated patrons
Time frame: Change in refusal rate between baseline and 1 year posttest assessments
Primary outcome measure, refusal rate of alcohol service to apparently-intoxicated patrons, will be obtained via a pseudo-intoxicated patron (PiP) assessment. Confederate buyers will feign intoxication and record if servers agree to serve them an alcoholic beverage. PiP protocol presents a server with the most overt situation in which alcohol service should be refused, (i.e., when a patron is showing clear signs of intoxication), models behavior of patrons most at risk, and is relatively low cost.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Derived from this study: PubMed 38265847Woodall WG, Buller D, Saltz R, Martinez L. Professional Development to Improve Responsible Beverage Service Training: Formative Research Results and Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jan 24;13:e49680. doi: 10.2196/49680.
- Derived from this study: PubMed 38227392Buller DB, Woodall GW, Saltz R, Martinez L, Small A, Chirico N, Cutter GR. Sales to Apparently Intoxicated Customers in Three States With Different Histories of Responsible Beverage Service Training. J Stud Alcohol Drugs. 2024 May;85(3):312-321. doi: 10.15288/jsad.23-00258. Epub 2024 Jan 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Buller, PhD principal investigator
Klein Buendel, Inc.
Gill Woodall, PhD principal investigator
Klein Buendel, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WayToServe Plus In-service Component and WayToServe Training Only in people with Alcohol Drinking and Alcohol Intoxication, run by Klein Buendel, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refusal rate of alcohol service to apparently-intoxicated patrons (time frame: Change in refusal rate between baseline and 1 year posttest assessments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779774, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.