Cell Phone UseNCT05163119
Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use
A study testing Commercial Cellphone-Blocking App (Active) and Driving Mode in people with Cell Phone Use and Automobile Driving, run by Motao Zhu at 1 site in United States.
Trial summary
The purpose of this study is to conduct a randomized controlled trial to determine the effects of a cellphone app and a driving mode intervention on driving behavior in drivers aged 18-24 years. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Cell Phone Use, Automobile Driving
- What is being tested?
- Commercial Cellphone-Blocking App (Active) and Driving Mode
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18-24 years of age at time of recruitment
- Must have ownership and exclusive access to a passenger vehicle
- Must have car insurance with at least state-minimum coverage
- Must live in Greater Columbus (Ohio) area
- Must drive at least 2 days a week on average
- Must have functioning iPhone or Android smartphone with an active phone service account (Ex: Verizon, AT\&T, etc.)
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- Must self-report handheld calling or texting while driving (≥ 1 time/week)
- Must not be enrolled in another driving-related research study during the study period.
- Must be willing to be randomized and comply with study requirements
- Must have no plans to change cellphones or vehicles in next 6 months or agree to transfer FleetSafer app/DriveCam if they change cellphones or vehicles
- Must speak and read English
Who cannot join
- Drivers under 18 years of age
- Drivers holding learner's permits
- Drivers who share a vehicle with a family member or others
- Infrequent drivers (Drive 2 days a week or less)
- Participants from the pilot R21 project
- Current users of a cellphone-blocking app or driving mode who do not agree to uninstall/de-activate the app for the duration of participation in the study
- Current users of a car insurance monitoring device (physical device or app)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Motao Zhu, MD,MS,PhD, 614-355-6687, motao.zhu@nationwidechildrens.org
Motao Zhu, MD,MS,PhD
About this study
The purpose of this study is to conduct a randomized controlled trial to determine the effects of a cellphone app and a driving mode intervention on driving behavior in drivers aged 18-24 years.
Read the detailed description
For this study, 1200 teens aged 18-24 years will be randomized into one of three study groups for 6 months. Researchers aim to evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on cellphone use while driving and evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on high-risk driving events.
- Conditions
- Cell Phone Use, Automobile Driving
- Being tested
- Commercial Cellphone-Blocking App (Active), Driving Mode
- Keywords
- Texting, Driving, Mobile Technology
- Medical subject headings
- Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial Cellphone-Blocking App (Active)Behavioural
The Fleetsafer app, which is a commercial cellphone app that uses a cellphone's standard sensors and function to block handheld cellphone use while driving, will be downloaded on the participant's smartphone.
Driving ModeBehavioural
Apple's "Do Not Disturb" driving mode provided by Apple for iPhones or Google Do Not Disturb, Verizon Messages +, Android Auto or have another app, called LifeSaver installed on their Android phone (collectively referred to as driving modes; the specific driving mode for participants in this arm will be determined based on smartphone type and service provider).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Commercial cell-phone blocking app installed on smartphone, but app will be inactive. |
| Commercial Cellphone-Blocking App | Experimental | Commercial cellphone-blocking app that blocks handheld cellphone use while driving, but allows emergency calls and phone use after pressing the passenger button will be installed on smartphone. Receives: Behavioral: Commercial Cellphone-Blocking App (Active) |
| Driving Mode | Experimental | Driving mode blocks handheld phone use while driving or facilitates hands free use (exact functionality dependent on smartphone type and service provider).This group will also have the commercial cell-phone blocking app installed on smartphone, but app will be inactive. Receives: Behavioral: Driving Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calling, texting, and handheld cell phone use while driving
Number of calling occurrences, texting occurrences, and handheld phone use occurrences, per 1,000 miles driven. Higher numbers signify more calling, texting, and handheld cell phone use.
Measured: 5-month intervention period
High-risk driving events
Total number of high-risk driving events (e.g., hard-braking, sudden acceleration, swerving) per 1,000 miles driven. Higher numbers signify more high-risk driving events.
Measured: 5-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start9 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cell Phone UseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Motao Zhu
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ohio State University, University of Iowa
- Responsible party
- Sponsor-investigator, Motao Zhu, Nationwide Children's Hospital
- Investigators
- Motao Zhu, Principal investigator, Abigail Wexner Research Institute at Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163119
- Sponsor's protocol ID
- STUDY00001601
- Other IDs
- R01HD102439
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use
- ClinicalTrials.gov ID
- NCT05163119
- Acronym / sponsor ID
- STUDY00001601
- Conditions
- Cell Phone Use, Automobile Driving
- Keywords
- Texting, Driving, Mobile Technology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Motao ZhuUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ohio State University, University of Iowa
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Dec 2021 (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.
The purpose of this study is to conduct a randomized controlled trial to determine the effects of a cellphone app and a driving mode intervention on driving behavior in drivers aged 18-24 years.
Detailed description
For this study, 1200 teens aged 18-24 years will be randomized into one of three study groups for 6 months. Researchers aim to evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on cellphone use while driving and evaluate the effectiveness of commercial cellphone-blocking apps and driving mode interventions on high-risk driving events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Commercial cell-phone blocking app installed on smartphone, but app will be inactive. |
| Commercial Cellphone-Blocking App | Experimental | Behavioral: Commercial Cellphone-Blocking App (Active)Commercial cellphone-blocking app that blocks handheld cellphone use while driving, but allows emergency calls and phone use after pressing the passenger button will be installed on smartphone. |
| Driving Mode | Experimental | Behavioral: Driving ModeDriving mode blocks handheld phone use while driving or facilitates hands free use (exact functionality dependent on smartphone type and service provider).This group will also have the commercial cell-phone blocking app installed on smartphone, but app will be inactive. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Adults 18-24 years of age at time of recruitment
- Must have ownership and exclusive access to a passenger vehicle
- Must have car insurance with at least state-minimum coverage
- Must live in Greater Columbus (Ohio) area
- Must drive at least 2 days a week on average
Key exclusion criteria (7 listed)
- Drivers under 18 years of age
- Drivers holding learner's permits
- Drivers who share a vehicle with a family member or others
- Infrequent drivers (Drive 2 days a week or less)
- Participants from the pilot R21 project
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 |
|---|---|---|
| Commercial Cellphone-Blocking App (Active)The Fleetsafer app, which is a commercial cellphone app that uses a cellphone's standard sensors and function to block handheld cellphone use while driving, will be downloaded on the participant's smartphone. | Behavioural | Commercial Cellphone-Blocking App |
| Driving ModeApple's "Do Not Disturb" driving mode provided by Apple for iPhones or Google Do Not Disturb, Verizon Messages +, Android Auto or have another app, called LifeSaver installed on their Android phone (collectively referred to as driving modes; the specific driving mode for participants in this arm will be determined based on smartphone type and service provider). | Behavioural | Driving Mode |
Primary outcome
Calling, texting, and handheld cell phone use while driving
Time frame: 5-month intervention period
Number of calling occurrences, texting occurrences, and handheld phone use occurrences, per 1,000 miles driven. Higher numbers signify more calling, texting, and handheld cell phone use.
High-risk driving events
Time frame: 5-month intervention period
Total number of high-risk driving events (e.g., hard-braking, sudden acceleration, swerving) per 1,000 miles driven. Higher numbers signify more high-risk driving events.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Motao Zhu principal investigator
Abigail Wexner Research Institute at Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial Cellphone-Blocking App (Active) and Driving Mode in people with Cell Phone Use and Automobile Driving, run by Motao Zhu 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 11 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Motao Zhu, MD,MS,PhD ((614)-355-6687, motao.zhu@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calling, texting, and handheld cell phone use while driving (time frame: 5-month intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.