Recruiting

Mobile Technology

Sponsor:

Motao Zhu

Code:

NCT05163119

Conditions

Cell Phone Use

Automobile Driving

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Accepted

Interventions

Commercial Cellphone-Blocking App (Active)

Driving Mode

Study Details

Brief 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.

Conditions

Cell Phone Use

Automobile Driving

Study ID

NCT05163119

Start date

Nov 9, 2022

Status verified date

Sep, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.)
  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control Group

Commercial cell-phone blocking app installed on smartphone, but app will be inactive.

experimental: Commercial Cellphone-Blocking App

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.

experimental: Driving Mode

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.

Interventions

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.

Driving Mode

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).

Primary outcome measure

  • Calling, texting, and handheld cell phone use while driving [ Time Frame: 5-month intervention period ]
  • High-risk driving events [ Time Frame: 5-month intervention period ]

Central Contacts and Locations

Central contacts

Motao Zhu, MD,MS,PhD

(614)-355-6687motao.zhu@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Motao Zhu, MD,MS,PhD

614-355-6687motao.zhu@nationwidechildrens.org

Principal Investigator:

Motao Zhu, MD,MS,PhD

More Information

Sponsor

Motao Zhu

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • Texting
  • Driving
  • Mobile Technology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Motao Zhu on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.