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Smartphone-paired Breathalyzers and Loss- and Gain-framed Texts for Reducing Drinking and Driving (BESAFE)

Primary Purpose

Alcohol Drinking, Alcohol Intoxication, Alcohol Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Loss-framed text message
Gain-Framed text message
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking focused on measuring alcohol, driving, breathalyzers, smartphone

Eligibility Criteria

21 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Loss-Framed Text Messages

Control

Gain-Framed Messaging Group

Arm Description

Loss-framed text message

Participants in this arm will not receive any intervention.

Gain-framed text message

Outcomes

Primary Outcome Measures

The primary outcome measure will be the change in proportion of breathalyzer measurements submitted with self-reported drinking episodes across groups.

Secondary Outcome Measures

Change in frequency of BACtrack monitoring within intervention group from baseline
Drinking and driving episodes in which their BAC via self-report or BAC measure is expected to be positive
To be assessed using a driving monitoring app passively running on participants' phones throughout the trial
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)
Participants are able to guess their BAC within the app before collecting the measurement. We will examine the changes in the accuracy of their guesses over time

Full Information

First Posted
October 5, 2017
Last Updated
August 6, 2018
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03335735
Brief Title
Smartphone-paired Breathalyzers and Loss- and Gain-framed Texts for Reducing Drinking and Driving
Acronym
BESAFE
Official Title
Pilot Trial Leveraging Smartphone-paired Breathalyzers and Loss- and Gain-framed Text Notifications for Reducing Drinking Driving
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
April 9, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

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
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.
Detailed Description
The overall objective of this project is to leverage smartphone-paired breathalyzers to implement cost-effective and scalable behavioral interventions to reduce risky drinking behaviors such as drinking and driving. Prospect theory proposes that messages framed in different ways can elicit different responses from individuals. 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. People are more motivated to avoid losing something than they are to win something. Studies have found that delivering messaging framed as a loss are also effective in motivating certain behaviors. On the other hand, gain-framed messages have been shown to have a positive effect on preventative healthcare. By using automated remote monitoring, innovative loss aversion and gain-framed messaging strategies incorporating insights from behavioral economics could be more easily implemented by delivering effective messaging prior to a risky behavior taking place. The investigators hope that the use of loss aversive and/or gain-framed messaging will lead to individuals improving planning behavior around drinking, especially in regards to drinking and driving. The objective of this project is to demonstrate the feasibility of a scalable intervention using loss- gain-framed messaging to reduce drinking and driving, compare the effectiveness of each type of messaging, and to increase the use of Blood Alcohol Content (BAC) monitors as a way to plan safer strategies when drinking. The investigators' long-term objective is to secure federal funding for research that leverages insights from behavioral economics supported by smartphone technology to reduce risky drinking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Intoxication, Alcohol Impairment, Drive, Driving Impaired, Driving Under the Influence, Behavior, Drinking
Keywords
alcohol, driving, breathalyzers, smartphone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participant will be blinded to their random assignment into the control, loss-framed messaging, or gain-framed messaging group.
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loss-Framed Text Messages
Arm Type
Experimental
Arm Description
Loss-framed text message
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this arm will not receive any intervention.
Arm Title
Gain-Framed Messaging Group
Arm Type
Experimental
Arm Description
Gain-framed text message
Intervention Type
Behavioral
Intervention Name(s)
Loss-framed text message
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Gain-Framed text message
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measure will be the change in proportion of breathalyzer measurements submitted with self-reported drinking episodes across groups.
Time Frame
baseline up to 8 weeks
Secondary Outcome Measure Information:
Title
Change in frequency of BACtrack monitoring within intervention group from baseline
Time Frame
baseline up to 8 weeks
Title
Drinking and driving episodes in which their BAC via self-report or BAC measure is expected to be positive
Description
To be assessed using a driving monitoring app passively running on participants' phones throughout the trial
Time Frame
baseline up to 8 weeks
Title
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)
Description
Participants are able to guess their BAC within the app before collecting the measurement. We will examine the changes in the accuracy of their guesses over time
Time Frame
baseline up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kit Delgado, MD, MS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
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Links:
URL
http://www.bactrack.com/products/bactrack-mobile-breathalyzer?gclid=Cj0KEQiAzO6zBRC25Ju1idGJiZkBEiQAP3Sf6MVZKaULJEmXCJnBgqXvqrzfuiYe3hpIEsgMir1_QXUaAl_o8P8HAQ
Description
BacTrack Mobile Pro breathalyzer device
URL
http://www-nrd.nhtsa.dot.gov/Pubs/812139.pdf
Description
National Highway Traffic Safety Administration. Traffic Safety Facts: Alcohol-Impaired Driving.; 2015
URL
http://www.cdc.gov/brfss/brfssprevalence
Description
Centers for Disease Control and Prevention. BRFSS Prevalence & Trends Data.; 2015

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Smartphone-paired Breathalyzers and Loss- and Gain-framed Texts for Reducing Drinking and Driving

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