Back to resultsSmartphone Technology: Young Adult Drinking (STEADY)
Primary Purpose
Alcohol Use, Alcohol Drinking, Drinking Behavior
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Smartphone breathalyzer device/app use
BAC estimator app use
Text messaging procedure
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Use focused on measuring Brief intervention, Harm reduction, Young adult, College Student
Eligibility Criteria
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
Sites / Locations
- EDGE Laboratory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Smartphone breathalyzer device & app
BAC estimator app
Text Messaging
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Quantity of alcohol consumption
Compare forms of mobile technology for their effects on alcohol consumption
Secondary Outcome Measures
Quantity of alcohol consumption
Compare forms of mobile technology for their effects on alcohol consumption
Full Information
NCT ID
NCT02963818
First Posted
November 8, 2016
Last Updated
June 21, 2019
Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT02963818
Brief Title
Smartphone Technology: Young Adult Drinking
Acronym
STEADY
Official Title
Smartphone Technology Effects on Alcohol Drinking Among Young (STEADY) Adults Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Alcohol Drinking, Drinking Behavior
Keywords
Brief intervention, Harm reduction, Young adult, College Student
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smartphone breathalyzer device & app
Arm Type
Experimental
Arm Description
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.
Arm Title
BAC estimator app
Arm Type
Experimental
Arm Description
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.
Arm Title
Text Messaging
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Smartphone breathalyzer device/app use
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
BAC estimator app use
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Text messaging procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quantity of alcohol consumption
Description
Compare forms of mobile technology for their effects on alcohol consumption
Time Frame
During one alcohol drinking session, an average of 2 hours
Secondary Outcome Measure Information:
Title
Quantity of alcohol consumption
Description
Compare forms of mobile technology for their effects on alcohol consumption
Time Frame
two-week field period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert F Leeman, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
EDGE Laboratory
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34766785
Citation
Leeman RF, Berey BL, Frohe T, Rowland BHP, Martens MP, Fucito LM, Stellefson M, Nixon SJ, O'Malley SS. A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults. Psychol Addict Behav. 2022 Sep;36(6):710-723. doi: 10.1037/adb0000780. Epub 2021 Nov 11.
Results Reference
derived
Learn more about this trial
Smartphone Technology: Young Adult Drinking
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