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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Weekly SMS Support text
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.
Behavioral: Weekly SMS Support text
Participants will receive a support SMS to troubleshoot, etc. if the Way to Drive app is not collecting trip data.
Behavioral: Persuasive education
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.
Behavioral: WOOP (aka, mental contrasting with implementation intentions., Wish, Outcome, Obstacle, Plan)
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.
Behavioral: Customized Habit Tips
Participants will receive weekly text-message tips, informed by findings from survey responses, plus reminders to address stated obstacles.
Behavioral: Weekly SMS Encouragement
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.
Behavioral: Weekly SMS Support text
Participants will receive a support SMS to troubleshoot, etc. if the Way to Drive app is not collecting trip data.
Behavioral: Persuasive education
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.
Behavioral: WOOP (aka, mental contrasting with implementation intentions., Wish, Outcome, Obstacle, Plan)
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.
Behavioral: Customized Habit Tips
Participants will receive weekly text-message tips, informed by findings from survey responses, plus reminders to address stated obstacles.
Behavioral: Weekly SMS Encouragement
Those who have a perfect streak going midway through each week will receive an additional encouraging message cheering them on.
Behavioral: Raffle Financial Incentive
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.
Behavioral: Weekly SMS Support text
Participants will receive a support SMS to troubleshoot, etc. if the Way to Drive app is not collecting trip data.
Behavioral: Persuasive education
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.
Behavioral: WOOP (aka, mental contrasting with implementation intentions., Wish, Outcome, Obstacle, Plan)
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.
Behavioral: Customized Habit Tips
Participants will receive weekly text-message tips, informed by findings from survey responses, plus reminders to address stated obstacles.
Behavioral: Weekly SMS Encouragement
Those who have a perfect streak going midway through each week will receive an additional encouraging message cheering them on.
Behavioral: Shared Pot Financial Incentive
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
General Motors (GM)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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