Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation

NCT05227027 | Completed Results

• 4 other identifiers: 19-29335NCI-2021-07004P30AG012839R21CA238301
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of a video game embedded in a commercially available mobile application (app) for smoking cessation. Smokers are increasingly turning to mobile health apps for assistance with quitting smoking, and there is a critical need for strategies to engage app users to increase retention and efficacy. Video games are designed to increase users' motivation and engagement, which in turn may increase their exposure and adherence to a smoking cessation program. The hypothesis is that the game increases engagement, retention, and smoking abstinence rates compared with a core version of the app without the game. A two-arm individually randomized pilot trial of 500 adult smokers will test this hypothesis, comparing outcomes for participants randomized to receive the core app plus embedded game with participants randomized to receive the core app only. Primary outcomes relate to user engagement with the app. Secondary outcomes relate to user engagement, efficacy (smoking abstinence), and user satisfaction.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (2)

• Number of Unique App Sessions

  Number of times the app was opened; passively collected by the app and averaged in analysis to calculate mean number of app opens by study group over the study period. A new session is defined as use of the app after at least 30 minutes of inactivity.

  Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

• Minutes of App Usage Per Session

  Passively collected by the app and averaged in analysis among those with a session to calculate mean number of minutes of usage per session by study group.

  Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

Secondary Outcomes (5)

• Unique Days With at Least One App Session

  Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

• Self-reported 7-day Point-prevalence Abstinence at 2 Months

  56 days after participant's selected quit date (56 to 63 days after enrollment)

• Self-reported 30-day Point-prevalence Abstinence at 2 Months

  56 days after participant's selected quit date (56 to 63 days after enrollment)

• Satisfaction With App

  56 days after participant's selected quit date (56 to 63 days after enrollment)

• Satisfaction With Game (Intervention Group Only)

  56 days after participant's selected quit date (56 to 63 days after enrollment)

Other Outcomes (9)

• Biochemically Verified 7-day Point-prevalence Abstinence at 2 Months

  56 days after participant's selected quit date (56 to 63 days after enrollment)

• Biochemically Verified 30-day Point-prevalence Abstinence at 2 Months

  56 days after participant's selected quit date (56 to 63 days after enrollment)

• Repeated 1-day Point-prevalence Smoking Abstinence

  During the 56 days after participant's selected quit date

Study Arms (2)

Education plus game module

EXPERIMENTAL

Participants receive an educational intervention through the Smoke Free application with the embedded game module. Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

Behavioral: Game Module; Behavioral: Smoke Free smartphone application

Education module only

ACTIVE COMPARATOR

Participants receive an educational intervention through the Smoke Free application only (core app only). Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

Behavioral: Smoke Free smartphone application

Interventions

Game Module BEHAVIORAL

Receive access to the the game module through the free, 'Smoke Free' smartphone application

Also known as: In-application game module

Education plus game module

Smoke Free smartphone application BEHAVIORAL

Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)

Also known as: Educational intervention

Education module only; Education plus game module

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provides electronic informed consent.
• Male or female, aged 18 and older
• Has downloaded and opened the Smoke Free app
• A smoker of at least 1 cigarette per day
• Plans to quit smoking within the next 7 days
• Speaks, reads, and writes English
• Lives in the United States

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator
• National Institute on Aging (NIA): collaborator
• University of California, Berkeley: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

• White JS, Salem MK, Toussaert S, Westmaas JL, Raiff BR, Crane D, Warrender E, Lyles C, Abroms L, Thrul J. Developing a Game (Inner Dragon) Within a Leading Smartphone App for Smoking Cessation: Design and Feasibility Evaluation Study. JMIR Serious Games. 2023 Aug 11;11:e46602. doi: 10.2196/46602.

  PMID: 37566442 BACKGROUND

• White JS, Toussaert S, Raiff BR, Salem MK, Chiang AY, Crane D, Warrender E, Lyles CR, Abroms LC, Westmaas JL, Thrul J. Evaluating the Impact of a Game (Inner Dragon) on User Engagement Within a Leading Smartphone App for Smoking Cessation: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 30;26:e57839. doi: 10.2196/57839.

  PMID: 39475840 DERIVED

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Dr. Justin White, Associate Professor
• Organization: University of California, San Francisco

justin.white@ucsf.edu

415-476-8045

Study Officials

• Justin White, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: February 9, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: January 3, 2024
• Results First Posted: January 3, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)