NCT03335735

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 21, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

October 5, 2017

Last Update Submit

August 6, 2018

Conditions

Keywords

alcoholdrivingbreathalyzerssmartphone

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

EXPERIMENTAL

Loss-framed text message

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

Behavioral: Gain-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.

Loss-Framed Text Messages

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.

Gain-Framed Messaging Group

Eligibility Criteria

Age21 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Related Publications (16)

  • 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.

    PMID: 24881329BACKGROUND
  • Sloan 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.

    PMID: 24603444BACKGROUND
  • Naimi 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.

    PMID: 12503979BACKGROUND
  • Matjasko 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.

    PMID: 27102853BACKGROUND
  • Schneider 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.

    PMID: 11515737BACKGROUND
  • Toll 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.

    PMID: 18072836BACKGROUND
  • List 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.

    PMID: 25530206BACKGROUND
  • MacKillop 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.

    PMID: 21373791BACKGROUND
  • Petry 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.

    PMID: 10780125BACKGROUND
  • Loewenstein 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.

    PMID: 18042920BACKGROUND
  • Patel 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.

    PMID: 25569175BACKGROUND
  • Sobell 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.

    PMID: 8889403BACKGROUND
  • Case 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.

    PMID: 25668268BACKGROUND
  • South 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.

    PMID: 25790382BACKGROUND
  • Byrnes 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.

    PMID: 26206448BACKGROUND
  • Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, Sproat S, Hyson C, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial. Ann Intern Med. 2016 Mar 15;164(6):385-94. doi: 10.7326/M15-1635. Epub 2016 Feb 16.

    PMID: 26881417BACKGROUND

Related Links

MeSH Terms

Conditions

Alcohol DrinkingAlcoholic IntoxicationDriving Under the InfluenceDrinking Behavior

Condition Hierarchy (Ancestors)

BehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCriminal BehaviorDangerous Behavior

Study Officials

  • Kit Delgado, MD, MS

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

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.

Locations