Alcohol Drinking Clinical Trial
— BESAFEOfficial title:
Pilot Trial Leveraging Smartphone-paired Breathalyzers and Loss- and Gain-framed Text Notifications for Reducing Drinking Driving
NCT number | NCT03335735 |
Other study ID # | 827345 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 21, 2017 |
Est. completion date | June 30, 2018 |
Verified date | August 2018 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 58 |
Est. completion date | June 30, 2018 |
Est. primary completion date | April 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 39 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. — View Citation
MacKillop J, Amlung MT, Few LR, Ray LA, Sweet LH, Munafò 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in frequency of BACtrack monitoring within intervention group from baseline | baseline up to 8 weeks | ||
Secondary | 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 | baseline up to 8 weeks | |
Secondary | 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 | baseline up to 8 weeks |
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