- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05469477
Increasing Seat Belt Wearing and Decreasing Handheld Phone Use While Driving
September 29, 2023 updated by: M. Kit Delgado, MD, University of Pennsylvania
Behavioral Interventions to Increase Seat Belt Wearing and Decrease Handheld Phone Use While Driving
The study team is proposing to conduct a randomized controlled trial to determine the effectiveness of behavioral and financial incentives on phone use while driving and seat belt adherence.
Each arm will receive a support text if their app is not collecting data.
The behavioral engagement intervention includes persuasive education, mental contrasting with implementation intentions, customized habit tips, weekly feedback about participants' streaks, and encouraging SMS texts.
The two financial incentive interventions add on weekly raffles or shared pots for participants with perfect streaks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Behavioral: Weekly SMS Support text
- Behavioral: Persuasive education
- Behavioral: WOOP (aka, mental contrasting with implementation intentions., Wish, Outcome, Obstacle, Plan)
- Behavioral: Customized Habit Tips
- Behavioral: Weekly SMS Encouragement
- Behavioral: Raffle Financial Incentive
- Behavioral: Shared Pot Financial Incentive
Study Type
Interventional
Enrollment (Actual)
1139
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 Contact
- Name: Dina Abdel-Rahman, BS
- Phone Number: 267-438-7201
- Email: dina.abdel-rahman@pennmedicine.upenn.edu
Study Locations
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Are a GM/OnStar customer.
- Are 18 or older.
- Meet minimum trip requirements.
- Uses vehicle with OnStar
- At least 5 weeks of baseline trip data with >=8 trips/week at baseline on average
- Baseline seat belt use <= 75% on trips less than 2 miles and <= 90 on trips greater than 2 miles
- English reading ability
- Have an email address
- Have a smartphone with iPhone iOS 12 or later or Android OS 7 or later
Exclusion Criteria:
- You are unable to read and understand English
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: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control
Participants are asked to buckle up and not engage in handheld phone use while driving.
No further messaging will be provided about their behavior, and participants will not receive financial incentives for avoiding risky driving behavior.
|
Participants will receive a support SMS to troubleshoot, etc. if the Way to Drive app is not collecting trip data.
|
Experimental: Behavioral Engagement
Participants will receive a multicomponent safer driving intervention based on behavioral science.
This will include persuasive education, WOOP (mental contrasting with implementation intentions) and customized habit tips.
|
Participants will receive a support SMS to troubleshoot, etc. if the Way to Drive app is not collecting trip data.
The research team will use psychology and communications research to present information about seat belts and distracted driving in a way that builds intrinsic motivation to change.
Because positively framed messages are more effective at promoting seat belt wearing, the team's messaging will employ this framing.
Education will address common reasons that survey participants give for not consistently buckling up or for phone use while driving.
Participants will receive an intervention on improving driving behavior with a specific goal in mind and how to reach that goal.
Participants will do this by thinking through 4 parts: a wish, an outcome, an obstacle and a plan.
This has been shown to build motivation, and help achieve the desired change.
Participants will receive weekly text-message tips, informed by findings from survey responses, plus reminders to address stated obstacles.
Those who have a perfect streak going midway through each week will receive an additional encouraging message cheering them on.
|
Experimental: Raffle incentive + behavioral engagement
Participants will receive the entire multicomponent safer driving behavioral intervention from arm 2. Participants will also be eligible for the Raffle Financial incentive, where participants can earn prize money for seat belt adherence and/or no phone use while driving.
|
Participants will receive a support SMS to troubleshoot, etc. if the Way to Drive app is not collecting trip data.
The research team will use psychology and communications research to present information about seat belts and distracted driving in a way that builds intrinsic motivation to change.
Because positively framed messages are more effective at promoting seat belt wearing, the team's messaging will employ this framing.
Education will address common reasons that survey participants give for not consistently buckling up or for phone use while driving.
Participants will receive an intervention on improving driving behavior with a specific goal in mind and how to reach that goal.
Participants will do this by thinking through 4 parts: a wish, an outcome, an obstacle and a plan.
This has been shown to build motivation, and help achieve the desired change.
Participants will receive weekly text-message tips, informed by findings from survey responses, plus reminders to address stated obstacles.
Those who have a perfect streak going midway through each week will receive an additional encouraging message cheering them on.
Each week, participants who adhere to seat belt use or abstain from phone use while driving get a chance at prize money.
One winner will be randomly chosen for each target behavior and earn prize money; the rest will not receive compensation.
|
Experimental: Shared pot incentive + behavioral engagement
Participants will receive the entire multicomponent safer driving behavioral intervention from arm 2. This arm will be identical to Arm 3, except there will be a shared pot financial incentive instead of a raffle.
Participants that abstain from phone use while driving and seat belt adherence earn an equal share of prize money allocated for the entire group.
|
Participants will receive a support SMS to troubleshoot, etc. if the Way to Drive app is not collecting trip data.
The research team will use psychology and communications research to present information about seat belts and distracted driving in a way that builds intrinsic motivation to change.
Because positively framed messages are more effective at promoting seat belt wearing, the team's messaging will employ this framing.
Education will address common reasons that survey participants give for not consistently buckling up or for phone use while driving.
Participants will receive an intervention on improving driving behavior with a specific goal in mind and how to reach that goal.
Participants will do this by thinking through 4 parts: a wish, an outcome, an obstacle and a plan.
This has been shown to build motivation, and help achieve the desired change.
Participants will receive weekly text-message tips, informed by findings from survey responses, plus reminders to address stated obstacles.
Those who have a perfect streak going midway through each week will receive an additional encouraging message cheering them on.
This will be identical to the raffle incentive, except that each week participants who adhere to seat belt use or abstain from phone use while driving will be guaranteed an equal share of prize money.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of trips with seat belt use
Time Frame: 105 days
|
Calculated as the number of trips during which a driver's seat belt click was detected, divided by total number of trips (defined as 1/10 of a mile or greater).
|
105 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seconds of active (handheld) phone use per hour of driving
Time Frame: 105 days
|
This is a composite outcome that measures the proportion of total trip time in which the driver is engaged in handheld phone call use or non-call handheld use (e.g.
texting, swiping, and typing), as measured by the Way to Drive app.
|
105 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mucio Delgado, 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
- Klauer SG, Guo F, Simons-Morton BG, Ouimet MC, Lee SE, Dingus TA. Distracted driving and risk of road crashes among novice and experienced drivers. N Engl J Med. 2014 Jan 2;370(1):54-9. doi: 10.1056/NEJMsa1204142.
- Dingus TA, Guo F, Lee S, Antin JF, Perez M, Buchanan-King M, Hankey J. Driver crash risk factors and prevalence evaluation using naturalistic driving data. Proc Natl Acad Sci U S A. 2016 Mar 8;113(10):2636-41. doi: 10.1073/pnas.1513271113. Epub 2016 Feb 22.
- Gershon P, Sita KR, Zhu C, Ehsani JP, Klauer SG, Dingus TA, Simons-Morton BG. Distracted Driving, Visual Inattention, and Crash Risk Among Teenage Drivers. Am J Prev Med. 2019 Apr;56(4):494-500. doi: 10.1016/j.amepre.2018.11.024. Epub 2019 Feb 21.
- Simons-Morton BG, Guo F, Klauer SG, Ehsani JP, Pradhan AK. Keep your eyes on the road: young driver crash risk increases according to duration of distraction. J Adolesc Health. 2014 May;54(5 Suppl):S61-7. doi: 10.1016/j.jadohealth.2013.11.021.
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)
March 12, 2023
Primary Completion (Actual)
June 29, 2023
Study Completion (Actual)
June 29, 2023
Study Registration Dates
First Submitted
July 18, 2022
First Submitted That Met QC Criteria
July 18, 2022
First Posted (Actual)
July 21, 2022
Study Record Updates
Last Update Posted (Actual)
October 3, 2023
Last Update Submitted That Met QC Criteria
September 29, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 851411
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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