Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use

NCT05163119 | Recruiting DMC

• 2 other identifiers: STUDY00001601R01HD102439
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

Keywords

Texting; Driving; Mobile Technology

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  5-month intervention period

Study Arms (3)

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.

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.

Behavioral: Driving Mode

Interventions

Commercial Cellphone-Blocking App (Active) BEHAVIORAL

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.

Commercial Cellphone-Blocking App

Driving Mode BEHAVIORAL

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).

Driving Mode

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Motao Zhu: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Ohio State University: collaborator
• University of Iowa: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

MeSH Terms

Conditions

Cell Phone Use

Interventions

Exercise

Condition Hierarchy (Ancestors)

Communication; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Motao Zhu

  Abigail Wexner Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Motao Zhu, MD,MS,PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2021
• First Posted: December 20, 2021
• Study Start: November 9, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)