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

Not Applicable

Completed

Interventions: Behavioral: Game Module
Behavioral: Smoke Free smartphone application

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.

Detailed Description: PRIMARY OBJECTIVES:

I. Augment an existing smartphone cessation app for smoking cessation with a video game to increase user engagement.

II. Test the feasibility, engagement, and early efficacy of the 'gamified' app, compared to one without gamification.

OUTLINE:

Participants are recruited through the Smoke Free smartphone app and randomized to 1 of 2 arms.

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

ARM II: Participants receive an educational intervention through the Smoke Free application without the video game module (core app only). Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Education plus game module	Smoke Free smartphone application	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.
Education plus game module	Game Module	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.
Education module only	Smoke Free smartphone application	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.

Primary Outcome Measures

Name	Time	Method
Number of Unique App Sessions	Enrollment through 56 days after participant's selected quit date (56 to 63 days total)	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.
Minutes of App Usage Per Session	Enrollment through 56 days after participant's selected quit date (56 to 63 days total)	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.

Secondary Outcome Measures

Name	Time	Method
Unique Days With at Least One App Session	Enrollment through 56 days after participant's selected quit date (56 to 63 days total)	Number of unique days with at least one app session, passively collected by the app and averaged by study group.
Self-reported 7-day Point-prevalence Abstinence at 2 Months	56 days after participant's selected quit date (56 to 63 days after enrollment)	Proportion of participants who self-report having abstained for the prior 7 days during the 2-month follow-up assessment, assuming missing = smoking.
Self-reported 30-day Point-prevalence Abstinence at 2 Months	56 days after participant's selected quit date (56 to 63 days after enrollment)	Proportion of participants who who self-report having abstained for the prior 30 days during the 2-month follow-up assessment, assuming missing = smoking.
Satisfaction With App	56 days after participant's selected quit date (56 to 63 days after enrollment)	Rating of satisfaction with assigned app on a 5-point Likert scale from "Not at all" (1) to "Extremely" (5), assessed in the 2-month follow-up questionnaire. The measure is averaged by study group.
Satisfaction With Game (Intervention Group Only)	56 days after participant's selected quit date (56 to 63 days after enrollment)	Rating of satisfaction with the game on a 5-point Likert scale from "Not at all" (1) to "Extremely" (5), assessed in the 2-month follow-up questionnaire. The measure is averaged for the intervention group.

Locations (1): University of California San Francisco
🇺🇸
San Francisco, California, United States