Smartphone-paired Breathalyzers and Loss- and Gain-framed Texts for Reducing Drinking and Driving
BESAFE
Pilot Trial Leveraging Smartphone-paired Breathalyzers and Loss- and Gain-framed Text Notifications for Reducing Drinking Driving
1 other identifier
interventional
58
1 country
1
Brief Summary
This project aims to demonstrate the feasibility of a scalable behavioral intervention using smartphone-paired breathalyzers and text message aimed at reducing drinking and driving among individuals who report heavy drinking. All participants receive a smartphone breathalyzer to provide feedback on their estimated blood alcohol level. The intervention compares loss- and gain-framed messages that make the consequences of drinking and driving more salient to standard messages not to drink and drive.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2017
CompletedFirst Posted
Study publicly available on registry
November 8, 2017
CompletedStudy Start
First participant enrolled
December 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedAugust 8, 2018
August 1, 2018
4 months
October 5, 2017
August 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure will be the change in proportion of breathalyzer measurements submitted with self-reported drinking episodes across groups.
baseline up to 8 weeks
Secondary Outcomes (3)
Change in frequency of BACtrack monitoring within intervention group from baseline
baseline up to 8 weeks
Drinking and driving episodes in which their BAC via self-report or BAC measure is expected to be positive
baseline up to 8 weeks
Changes in accuracy of BAC guess vs actual BAC measure with continued use (Does a participant become more accurate overtime in predicting what their BAC will be prior to measuring)
baseline up to 8 weeks
Study Arms (3)
Loss-Framed Text Messages
EXPERIMENTALLoss-framed text message
Control
NO INTERVENTIONParticipants in this arm will not receive any intervention.
Gain-Framed Messaging Group
EXPERIMENTALGain-framed text message
Interventions
Participants in the intervention group will receive loss-framed text messages related to drinking and driving on days during the week with a higher likelihood of alcohol consumption (Thursday-Saturday). Loss aversion refers to people's tendency to prefer avoiding losses to acquiring equivalent gains: it's better to not lose $5 than to find $5, so the content of the messages will be related to loss of personal freedom, loss of money, and loss of future employment opportunities due to Driving Under the Influence (DUI) convictions.
Participants in the intervention group will receive gain-framed text messages related to drinking and driving on days during the week with a higher likelihood of alcohol consumption (Thursday-Saturday). Gain-framed messages have been shown to have a positive effect on preventative healthcare and include content framed in a manner that the participant gains something from taking preventative action. Message content will be related to saving lives, gaining control, and making loved ones happy.
Eligibility Criteria
You may qualify if:
- Between the ages of 21-39
- Reports an average of one heavy drinking day (men more than five drinks, women more than four drinks) per week over the preceding 8 weeks
- Has a valid photo identification (ID)
- Are willing and able to use an Uber or Lyft or septa as transportation home
- Drives four or more trips per week
- Owns an Apple iPhone or Android smartphone
You may not qualify if:
- Desire for alcohol treatment now or have received alcohol treatment within the past 6 months
- Alcohol use disorder rated as severe per DSM-V criteria
- Non-English-speaking
- Women who are pregnant
- Individuals who should not consume alcohol due to a medical condition such as liver disease, cancer, and seizure disorders. Participants will be asked to answer yes if they have any disorder that their doctor has suggested that they should not drink alcohol. If they are unsure or say I don't know the investigators will ask them to speak with their doctor prior to participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (16)
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PMID: 26881417BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kit Delgado, MD, MS
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participant will be blinded to their random assignment into the control, loss-framed messaging, or gain-framed messaging group.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2017
First Posted
November 8, 2017
Study Start
December 21, 2017
Primary Completion
April 9, 2018
Study Completion
June 30, 2018
Last Updated
August 8, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share
There is no plan to make individual participant data (IPD) available to other researchers. In fact, there will be an NIH Certificate of Confidentiality protecting participants' data.