- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02963818
Smartphone Technology: Young Adult Drinking (STEADY)
February 23, 2024 updated by: University of Florida
Smartphone Technology Effects on Alcohol Drinking Among Young (STEADY) Adults Study
Exploring technology based tools to reduce drinking is important.
The purpose of this research study is to compare different BAC monitoring apps for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in six phases: a web-based and in-person screening assessment; brief counseling session on the day before the alcohol drinking session; brief appointment on the day of the alcohol drinking session; alcohol drinking session; two-week field period; and a follow-up appointment.
Participation in this study will last approximately two months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Florida
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Gainesville, Florida, United States, 32611
- EDGE Laboratory
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be able to read/write English and complete study assessments
- Drink alcohol regularly
Exclusion Criteria:
- Test positive on a urine test for use of certain illegal drugs
- Undergraduate student enrolled at the University of Florida
- Graduate students from the College of Health and Human Performance at the University of Florida
- Pregnant, or currently breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smartphone breathalyzer device & app
This is a small device that connects to a smartphone with an accompanying app that produces accurate breath alcohol readings when a user blows into a small tube attached to the device.
Participants randomized to this study condition will have the opportunity to use this device and app during an alcohol drinking session in an actual bar and during a two-week field period.
|
Participants randomized to this condition will be able to blow into the smartphone breathalyzer after consuming each alcoholic drink, which produces an accurate breath alcohol reading on the app.
These breath alcohol readings may inform participants' subsequent decisions regarding drinking.
|
|
Experimental: BAC estimator app
This is an app that produces estimated blood alcohol content (eBAC) readings based on sex, weight, number of drinks and time taken to consume drinks.
Participants randomized to this study condition will have the opportunity to use this app during an alcohol drinking session in an actual bar and during a two-week field period.
|
Participants randomized to this condition will be able to make an entry into the BAC estimator app after consuming each alcoholic drink, which produces an estimated blood alcohol concentration based on the individual's sex, weight, number of alcoholic drinks and time spent drinking alcohol.
These estimated blood alcohol concentrations may inform participants' subsequent decisions regarding drinking.
|
|
Experimental: Text Messaging
A procedure whereby one sends a text message to the phone one is using after each alcoholic drink.
Participants randomized to this study condition will have the opportunity to the text messaging procedure during an alcohol drinking session in an actual bar and during a two-week field period.
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Participants randomized to this condition will be instructed to send a text to a smartphone they will use for the study after each alcoholic drink.
A consideration of the number of texts sent may inform participants' subsequent decisions regarding drinking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantity of alcohol consumption
Time Frame: During one alcohol drinking session, an average of 2 hours
|
Compare forms of mobile technology for their effects on alcohol consumption
|
During one alcohol drinking session, an average of 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantity of alcohol consumption
Time Frame: two-week field period
|
Compare forms of mobile technology for their effects on alcohol consumption
|
two-week field period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert F Leeman, Ph.D., University of Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
June 20, 2019
Study Completion (Actual)
June 20, 2020
Study Registration Dates
First Submitted
November 8, 2016
First Submitted That Met QC Criteria
November 10, 2016
First Posted (Estimated)
November 15, 2016
Study Record Updates
Last Update Posted (Actual)
February 26, 2024
Last Update Submitted That Met QC Criteria
February 23, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201600614-N
- R21AA023368 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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