Inspired: Smartphone Videogame-Based Smoking Cessation Intervention

• ClinicalTrials.gov Identifier: NCT03929003
• Recruitment Status: Completed
• First Posted: April 26, 2019
• Last Update Posted: March 10, 2020
• Sponsor: Rowan University
• Information provided by (Responsible Party): Rowan University

Tracking Information

• First Submitted Date: September 26, 2017
• First Posted Date: April 26, 2019
• Last Update Posted Date: March 10, 2020
• Actual Study Start Date: April 5, 2019
• Actual Primary Completion Date: January 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 24, 2019)

Smoking abstinence [ Time Frame: 7 days ]

self-report of smoking abstinence over the previous 7-day period.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 24, 2019)

Demographic [ Time Frame: 7 weeks ]

description of participants

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Inspired: Smartphone Videogame-Based Smoking Cessation Intervention
• Official Title: Breathe Free: Smartphone Videogame-Based Incentives for Smoking Cessation
• Brief Summary: The investigators are testing a new, smartphone videogame-based intervention for smoking cessation.
• Detailed Description: The investigators have developed a novel smartphone videogame, where smokers are required to submit breath carbon monoxide samples to demonstrate smoking abstinence, and where they will earn game-based rewards contingent on meeting CO goals. Players will be working with teams to earn group and social rewards to help advance their game.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two group randomization

Masking: Single (Participant)
Masking Description:

Participants will not be told whether they are in the control or experimental group.

Primary Purpose: Treatment

• Condition: Smoking Cessation

Intervention

Behavioral: Inspired

The investigators will be studying the ability of using videogame-based rewards to increase smoking abstinence when they are made contingent on meeting abstinence goals.

Study Arms

• Experimental: Contingent
  Participants in this arm will be required to meet CO goals in order to earn game-based rewards.
  Intervention: Behavioral: Inspired
• Active Comparator: Non-contingent
  Participants in this arm will submit CO verifications but will earn game-based rewards independent of meeting CO goals.
  Intervention: Behavioral: Inspired

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 9, 2020): 48
• Original Estimated Enrollment (submitted: April 24, 2019): 114
• Actual Study Completion Date: January 20, 2020
• Actual Primary Completion Date: January 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Inclusionary criteria: Participants will be required to be of legal smoking age (>19 in Alabama, Alaska, New Jersey, Utah, and in Onondaga, Nassau and Suffolk Counties in New York, > 18 years of age in the remainder of the United States). Participants must also report smoking >10 cigarettes per day, report smoking for >2 years, answer 8 or higher on a Likert scale asking how much the person wishes to quit smoking right now (1 = not at all, 10 =very much), have a smartphone with a data plan and active contract extending for at least two months from the enrollment date (i.e., the duration of the study), and reside in the U.S. Participants in the study must submit an initial CO reading > 10ppm (to prevent nonsmokers from enrolling in the study), Literacy will be assessed by having the participant read the first few lines of the consent form out loud, and will be an inclusion criterion because elements of "Breathe Free" will require reading.

Exclusion Criteria:

• Individuals will be excluded from the study if they report smoking any combustible products >2 times per month, report unstable medical/psychiatric conditions that might interfere with the study objectives (e.g., asthma), report living with someone who smokes in the house, or has a career that results in excessive exposure to CO. All excluded participants will be emailed the following smoking cessation information: the "Clearing the Air" packet developed by the National Cancer Institute, Smokefree.gov, Quitsmokinghelpline.com, and the National Academies Press "Dying to quit."

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03929003
• Other Study ID Numbers: ProG0520140170
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Rowan University
• Study Sponsor: Rowan University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Rowan University
• Verification Date: March 2020