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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335735
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Alcohol Intoxication Alcohol Impairment Drive Driving Impaired Driving Under the Influence Behavior, Drinking Behavioral: Loss-framed text message Behavioral: Gain-Framed text message Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participant will be blinded to their random assignment into the control, loss-framed messaging, or gain-framed messaging group.
Primary Purpose: Prevention
Official Title: Pilot Trial Leveraging Smartphone-paired Breathalyzers and Loss- and Gain-framed Text Notifications for Reducing Drinking Driving
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : June 30, 2018

Arm Intervention/treatment
Experimental: Loss-Framed Text Messages
Loss-framed text message
Behavioral: Loss-framed text message
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.

No Intervention: Control
Participants in this arm will not receive any intervention.
Experimental: Gain-Framed Messaging Group
Gain-framed text message
Behavioral: Gain-Framed text message
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 Measures :
  1. 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 Measures :
  1. Change in frequency of BACtrack monitoring within intervention group from baseline [ Time Frame: baseline up to 8 weeks ]
  2. Drinking and driving episodes in which their BAC via self-report or BAC measure is expected to be positive [ Time Frame: baseline up to 8 weeks ]
    To be assessed using a driving monitoring app passively running on participants' phones throughout the trial

  3. 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) [ Time Frame: baseline up to 8 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335735


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Kit Delgado, MD, MS University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Study Protocol  [PDF] October 4, 2017
Statistical Analysis Plan  [PDF] November 1, 2017

Additional Information:
Publications:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03335735    
Other Study ID Numbers: 827345
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
alcohol
driving
breathalyzers
smartphone
Additional relevant MeSH terms:
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Alcoholic Intoxication
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders