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

August 6, 2018 updated by: University of Pennsylvania

Pilot Trial Leveraging Smartphone-paired Breathalyzers and Loss- and Gain-framed Text Notifications for Reducing Drinking Driving

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

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

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

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 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants in this arm will not receive any intervention.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in frequency of BACtrack monitoring within intervention group from baseline
Time Frame: baseline up to 8 weeks
baseline up to 8 weeks
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
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)
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
baseline up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Kit Delgado, MD, MS, University of Pennsylvania

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.

General Publications

Helpful Links

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 (Actual)

December 21, 2017

Primary Completion (Actual)

April 9, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

October 5, 2017

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 827345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

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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