Alcohol DrinkingBESAFENCT03335735
Smartphone-paired Breathalyzers and Loss- and Gain-framed Texts for Reducing Drinking and Driving
A study testing Loss-framed text message and Gain-Framed text message in people with Alcohol Drinking and Alcohol Intoxication, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Intoxication, Alcohol Impairment
- What is being tested?
- Loss-framed text message and Gain-Framed text message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Drinking, Alcohol Intoxication, Alcohol Impairment, Drive, Driving Impaired, Driving Under the Influence
- Being tested
- Loss-framed text message, Gain-Framed text message
- Keywords
- alcohol, driving, breathalyzers, smartphone
- Medical subject headings
- Alcohol Drinking, Alcoholic Intoxication, Driving Under the Influence, Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loss-framed text messageBehavioural
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.
Gain-Framed text messageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Loss-Framed Text Messages | Experimental | Loss-framed text message Receives: Behavioral: Loss-framed text message |
| Control | No intervention | Participants in this arm will not receive any intervention. |
| Gain-Framed Messaging Group | Experimental | Gain-framed text message Receives: Behavioral: Gain-Framed text message |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the change in proportion of breathalyzer measurements submitted with self-reported drinking episodes across groups.
Measured: baseline up to 8 weeks
Secondary outcomes (3)
Change in frequency of BACtrack monitoring within intervention group from baseline
Measured: baseline up to 8 weeks
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
Measured: 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)
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
Measured: baseline up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start21 Dec 2017
- Primary completion9 Apr 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kit Delgado, MD, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335735
- Sponsor's protocol ID
- 827345
- Acronym
- BESAFE
- Status last verified
- Aug 2018
- First submitted
- 5 Oct 2017
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
White A, Hingson R. The burden of alcohol use: excessive alcohol consumption and related consequences among college students. Alcohol Res. 2013;35(2):201-18. doi: 10.35946/arcr.v35.2.11.
PubMed 24881329Sloan FA, Eldred LM, Xu Y. The behavioral economics of drunk driving. J Health Econ. 2014 May;35:64-81. doi: 10.1016/j.jhealeco.2014.01.005. Epub 2014 Feb 11.
PubMed 24603444Naimi TS, Brewer RD, Mokdad A, Denny C, Serdula MK, Marks JS. Binge drinking among US adults. JAMA. 2003 Jan 1;289(1):70-5. doi: 10.1001/jama.289.1.70.
PubMed 12503979Matjasko JL, Cawley JH, Baker-Goering MM, Yokum DV. Applying Behavioral Economics to Public Health Policy: Illustrative Examples and Promising Directions. Am J Prev Med. 2016 May;50(5 Suppl 1):S13-S19. doi: 10.1016/j.amepre.2016.02.007.
PubMed 27102853Schneider TR, Salovey P, Apanovitch AM, Pizarro J, McCarthy D, Zullo J, Rothman AJ. The effects of message framing and ethnic targeting on mammography use among low-income women. Health Psychol. 2001 Jul;20(4):256-66. doi: 10.1037//0278-6133.20.4.256.
PubMed 11515737Toll BA, O'Malley SS, Katulak NA, Wu R, Dubin JA, Latimer A, Meandzija B, George TP, Jatlow P, Cooney JL, Salovey P. Comparing gain- and loss-framed messages for smoking cessation with sustained-release bupropion: a randomized controlled trial. Psychol Addict Behav. 2007 Dec;21(4):534-44. doi: 10.1037/0893-164X.21.4.534.
PubMed 18072836List JA, Samek AS. The behavioralist as nutritionist: leveraging behavioral economics to improve child food choice and consumption. J Health Econ. 2015 Jan;39:135-46. doi: 10.1016/j.jhealeco.2014.11.002. Epub 2014 Nov 21.
PubMed 25530206MacKillop J, Amlung MT, Few LR, Ray LA, Sweet LH, Munafo MR. Delayed reward discounting and addictive behavior: a meta-analysis. Psychopharmacology (Berl). 2011 Aug;216(3):305-21. doi: 10.1007/s00213-011-2229-0. Epub 2011 Mar 4.
PubMed 21373791Petry NM, Martin B, Cooney JL, Kranzler HR. Give them prizes, and they will come: contingency management for treatment of alcohol dependence. J Consult Clin Psychol. 2000 Apr;68(2):250-7. doi: 10.1037//0022-006x.68.2.250.
PubMed 10780125Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available.
PubMed 18042920Patel MS, Asch DA, Volpp KG. Wearable devices as facilitators, not drivers, of health behavior change. JAMA. 2015 Feb 3;313(5):459-60. doi: 10.1001/jama.2014.14781. No abstract available.
PubMed 25569175Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996 Sep;42(1):49-54. doi: 10.1016/0376-8716(96)01263-x.
PubMed 8889403Case MA, Burwick HA, Volpp KG, Patel MS. Accuracy of smartphone applications and wearable devices for tracking physical activity data. JAMA. 2015 Feb 10;313(6):625-6. doi: 10.1001/jama.2014.17841. No abstract available.
PubMed 25668268South EC, Kondo MC, Cheney RA, Branas CC. Neighborhood blight, stress, and health: a walking trial of urban greening and ambulatory heart rate. Am J Public Health. 2015 May;105(5):909-13. doi: 10.2105/AJPH.2014.302526. Epub 2015 Mar 19.
PubMed 25790382Byrnes HF, Miller BA, Wiebe DJ, Morrison CN, Remer LG, Wiehe SE. Tracking Adolescents With Global Positioning System-Enabled Cell Phones to Study Contextual Exposures and Alcohol and Marijuana Use: A Pilot Study. J Adolesc Health. 2015 Aug;57(2):245-7. doi: 10.1016/j.jadohealth.2015.04.013.
PubMed 26206448
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial Leveraging Smartphone-paired Breathalyzers and Loss- and Gain-framed Text Notifications for Reducing Drinking Driving
- ClinicalTrials.gov ID
- NCT03335735
- Acronym / sponsor ID
- BESAFE / 827345
- Conditions
- Alcohol Drinking, Alcohol Intoxication, Alcohol Impairment, Drive, Driving Impaired, Driving Under the Influence
- Keywords
- alcohol, driving, breathalyzers, smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Loss-Framed Text Messages | Experimental | Behavioral: Loss-framed text messageLoss-framed text message |
| Control | No intervention | –Participants in this arm will not receive any intervention. |
| Gain-Framed Messaging Group | Experimental | Behavioral: Gain-Framed text messageGain-framed text message |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loss-framed text messageParticipants 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. | Behavioural | Loss-Framed Text Messages |
| Gain-Framed text messageParticipants 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. | Behavioural | Gain-Framed Messaging Group |
Primary outcome
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
3 secondary outcomes
Change in frequency of BACtrack monitoring within intervention group from baseline
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Background: PubMed 24881329White A, Hingson R. The burden of alcohol use: excessive alcohol consumption and related consequences among college students. Alcohol Res. 2013;35(2):201-18. doi: 10.35946/arcr.v35.2.11.
- Background: PubMed 24603444Sloan FA, Eldred LM, Xu Y. The behavioral economics of drunk driving. J Health Econ. 2014 May;35:64-81. doi: 10.1016/j.jhealeco.2014.01.005. Epub 2014 Feb 11.
- Background: PubMed 12503979Naimi TS, Brewer RD, Mokdad A, Denny C, Serdula MK, Marks JS. Binge drinking among US adults. JAMA. 2003 Jan 1;289(1):70-5. doi: 10.1001/jama.289.1.70.
- Background: PubMed 27102853Matjasko JL, Cawley JH, Baker-Goering MM, Yokum DV. Applying Behavioral Economics to Public Health Policy: Illustrative Examples and Promising Directions. Am J Prev Med. 2016 May;50(5 Suppl 1):S13-S19. doi: 10.1016/j.amepre.2016.02.007.
- Background: PubMed 11515737Schneider TR, Salovey P, Apanovitch AM, Pizarro J, McCarthy D, Zullo J, Rothman AJ. The effects of message framing and ethnic targeting on mammography use among low-income women. Health Psychol. 2001 Jul;20(4):256-66. doi: 10.1037//0278-6133.20.4.256.
- Background: PubMed 18072836Toll BA, O'Malley SS, Katulak NA, Wu R, Dubin JA, Latimer A, Meandzija B, George TP, Jatlow P, Cooney JL, Salovey P. Comparing gain- and loss-framed messages for smoking cessation with sustained-release bupropion: a randomized controlled trial. Psychol Addict Behav. 2007 Dec;21(4):534-44. doi: 10.1037/0893-164X.21.4.534.
- Background: PubMed 25530206List JA, Samek AS. The behavioralist as nutritionist: leveraging behavioral economics to improve child food choice and consumption. J Health Econ. 2015 Jan;39:135-46. doi: 10.1016/j.jhealeco.2014.11.002. Epub 2014 Nov 21.
- Background: PubMed 21373791MacKillop J, Amlung MT, Few LR, Ray LA, Sweet LH, Munafo MR. Delayed reward discounting and addictive behavior: a meta-analysis. Psychopharmacology (Berl). 2011 Aug;216(3):305-21. doi: 10.1007/s00213-011-2229-0. Epub 2011 Mar 4.
- Background: PubMed 10780125Petry NM, Martin B, Cooney JL, Kranzler HR. Give them prizes, and they will come: contingency management for treatment of alcohol dependence. J Consult Clin Psychol. 2000 Apr;68(2):250-7. doi: 10.1037//0022-006x.68.2.250.
- Background: PubMed 18042920Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available.
- Background: PubMed 25569175Patel MS, Asch DA, Volpp KG. Wearable devices as facilitators, not drivers, of health behavior change. JAMA. 2015 Feb 3;313(5):459-60. doi: 10.1001/jama.2014.14781. No abstract available.
- Background: PubMed 8889403Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996 Sep;42(1):49-54. doi: 10.1016/0376-8716(96)01263-x.
- BacTrack Mobile Pro breathalyzer deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kit Delgado, MD, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loss-framed text message and Gain-Framed text message in people with Alcohol Drinking and Alcohol Intoxication, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335735, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.